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## Protocol Section ### Identification Module **NCT ID:** NCT05013879 **Brief Title:** Kinesiotape for Edema After Bilateral Total Knee Arthroplasty **Official Title:** Effect of Kinesiotaping on Edema Management, Pain and Function on Patients With Bilateral Total Knee Arthroplasty #### Organization Study ID Info **ID:** 2021-13203 #### Organization **Class:** OTHER **Full Name:** Montefiore Medical Center ### Status Module #### Completion Date **Date:** 2023-11-24 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-24 **Type:** ACTUAL #### Start Date **Date:** 2021-10-18 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2021-08-19 **Type:** ACTUAL **Study First Submit Date:** 2021-08-02 **Study First Submit QC Date:** 2021-08-18 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Burke Rehabilitation Hospital #### Lead Sponsor **Class:** OTHER **Name:** Montefiore Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to determine if kinesiotaping for edema management will decrease post-operative edema in patients with bilateral total knee arthroplasty. The leg receiving kinesiotaping during inpatient rehabilitation may have decreased edema and pain and improved movement and function when compared to the leg not receiving kinesiotape. **Detailed Description:** After being informed about the study and potential risk, all patients undergoing inpatient rehabilitation after bilateral total knee arthroplasty will have Kinesio(R)Tape applied to one randomly selected leg while the other leg serves as a control. Measurement of bilateral leg circumference, knee range of motion, numerical rating scale for pain, and selected questions from the Knee Injury and Osteoarthritis Outcome Score will occur at regular intervals throughout the rehabilitation stay. Patients will receive standard rehabilitation. ### Conditions Module **Conditions:** - Arthroplasty Complications - Arthroplasty, Replacement, Knee **Keywords:** - edema - arthroplasty, knee, bilateral - kinesiotaping ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Repeated measures with two within-subjects factors: time and taped/untaped leg ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 65 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Kinesio(R)Tape for edema management applied to a randomly selected lower extremity plus standard inpatient rehabilitation after bilateral total knee arthroplasty **Intervention Names:** - Device: Kinesio(R)Tape for edema control **Label:** Kinesiotape leg plus standard rehabilitation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control leg receiving standard inpatient rehabilitation alone. **Label:** Control leg with standard rehabilitation alone **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Kinesiotape leg plus standard rehabilitation **Description:** Kinesio(R)Tape is an elastic, cotton tape with an adhesive backing. When applied for edema management, strips of Kinesio(R)Tape are applied to the lower leg in a criss-cross fashion by a physical therapist who is a Certified Kinesiotape Practitioner. **Name:** Kinesio(R)Tape for edema control **Other Names:** - kinesiotaping or kinesiological taping **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Bilateral circumferences, in centimeters, at the following points: 10 cm above the superior pole of the patella; middle of the knee joint; calf circumference at the broadest part of the calf and at 3 inches below the fibular head landmark; figure of eight method for foot and ankle circumference - a measurement from the lateral malleolus to the navicular tuberosity, under the plantar aspect of the foot towards the tuberosity of the fifth metatarsal, around to the medial malleolus, and posterior to the leg to return to the lateral malleolus. **Measure:** Change from baseline and during 1-2-day time intervals of circumferences of both knees and lower extremities **Time Frame:** During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8 #### Secondary Outcomes **Description:** Patient self-report: Pain rating for each leg on a integer scale of 0 (no pain) to 10 (worst pain imaginable) **Measure:** Change from baseline and day-to-day changes of bilateral knee pain on numerical pain rating scale **Time Frame:** During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8 **Description:** Physical therapist's measurement of active and active assistive knee range of motion (degrees) for flexion and extension using a standard goniometer **Measure:** Change from baseline and during 1-2-day time intervals for bilateral knee range of motion **Time Frame:** During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8 **Description:** Patient self-report using the KOOS sections relating to pain, stiffness, activities of daily living **Measure:** Change from baseline to Day 4 to Discharge Day for selected parts of the Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report **Time Frame:** At start of study, 4 days after start of study, and day 8 **Description:** Time (sec) to rise from a seated position, walk 10 m, turn, walk back to seat, and sit down. Patient will use appropriate assistive device and have appropriate guarding by a physical therapist. **Measure:** Change from baseline and during 1-2-day time intervals for Timed Up-and-Go Test **Time Frame:** During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * admitted to Burke Rehabilitation Hospital for inpatient rehabilitation within 5 days after same-day or staged bilateral total knee arthroplasty; * 50-85 years of age; * able to read and understand English or a hospital-provided translator when consenting for the study; * free from contraindications for kinesiotaping (see below); and, * able to tolerate an active rehabilitation program. Exclusion Criteria: * stage III or IV heart failure, stage III or IV renal failure; * fragile, very hairy or sensitive skin; * anesthesia or paraesthesia of any area of the lower extremity, except the surgical sites * active skin rashes or infections or skin lesions in the lower extremity; * prior history of allergic reactions to skin taping, bandaids, surgical tape; athletic tape or other skin-adhering electrode adhesives; * prior history of lower extremity lymphedema;3 * prior history of lower extremity venous or arterial disease; * post-operative complications in the surgical sites;4 * partial joint arthroplasty or revision arthroplasty of one or both knees;1,5 * inability to give informed consent offered in English or through a hospital-provided translator * age less than 50 years or over 85 years; * inability to tolerate an active rehabilitation program. **Maximum Age:** 85 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** White Plains **Country:** United States **Facility:** Burke Rehabilitation Hospital **State:** New York **Zip:** 10605 #### Overall Officials **Official 1:** **Affiliation:** Burke Rehabilitation Hospital **Name:** Suzanne Babyar, PT, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Tornatore L, De Luca ML, Ciccarello M, Benedetti MG. Effects of combining manual lymphatic drainage and Kinesiotaping on pain, edema, and range of motion in patients with total knee replacement: a randomized clinical trial. Int J Rehabil Res. 2020 Sep;43(3):240-246. doi: 10.1097/MRR.0000000000000417. **PMID:** 32459670 **Citation:** Guney Deniz H, Kinikli GI, Onal S, Sevinc C, Caglar O, Yuksei I. Comparison of Kinesio Tape application and manual lymphatic drainage on lower extremity oedema and functions after total knee arthroplasty. [Abstract]. Ann Rheum Dis. 2018; 77: 1791. **Citation:** Donec V, Krisciunas A. The effectiveness of Kinesio Taping(R) after total knee replacement in early postoperative rehabilitation period. A randomized controlled trial. Eur J Phys Rehabil Med. 2014 Aug;50(4):363-71. Epub 2014 May 13. **PMID:** 24819349 **Citation:** Sulman M, Riaz S, Khan RR, Faisal Z, Rajput R, Noor M. Effectiveness of Kinesio Taping on pain and function after total knee arthroplasty. Pak J Med Health Sci. 2020;14:1267-1270. **Citation:** Oktas B, Vergili O. The effect of intensive exercise program and kinesiotaping following total knee arthroplasty on functional recovery of patients. J Orthop Surg Res. 2018 Sep 12;13(1):233. doi: 10.1186/s13018-018-0924-9. **PMID:** 30208939 **Citation:** Alghadir A, Anwer S, Brismee JM. The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis. BMC Musculoskelet Disord. 2015 Jul 30;16:174. doi: 10.1186/s12891-015-0637-8. **PMID:** 26223312 **Citation:** Hancock GE, Hepworth T, Wembridge K. Accuracy and reliability of knee goniometry methods. J Exp Orthop. 2018 Oct 19;5(1):46. doi: 10.1186/s40634-018-0161-5. **PMID:** 30341552 **Citation:** Unver B, Ertekin O, Karatosun V. Pain, fear of falling and stair climbing ability in patients with knee osteoarthritis before and after knee replacement: 6 month follow-up study. J Back Musculoskelet Rehabil. 2014;27(1):77-84. doi: 10.3233/BMR-130422. **PMID:** 23948839 **Citation:** Bakar Y, Ozdemir OC, Sevim S, Duygu E, Tugral A, Surmeli M. Intra-observer and inter-observer reliability of leg circumference measurement among six observers: a single blinded randomized trial. J Med Life. 2017 Jul-Sep;10(3):176-181. **PMID:** 29075347 **Citation:** Collins NJ, Roos EM. Patient-reported outcomes for total hip and knee arthroplasty: commonly used instruments and attributes of a "good" measure. Clin Geriatr Med. 2012 Aug;28(3):367-94. doi: 10.1016/j.cger.2012.05.007. Epub 2012 Jun 22. **PMID:** 22840304 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M7657 - Name: Edema - Relevance: HIGH - As Found: Edema ### Condition Browse Module - Meshes - ID: D000004487 - Term: Edema ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01402479 **Brief Title:** An Open-labeled Trial of Ramipril in Patients With Migraine **Official Title:** An Open-labeled Trial of Ramipril in Patients With Migraine #### Organization Study ID Info **ID:** 0408-131-005 #### Organization **Class:** OTHER **Full Name:** Seoul National University Hospital ### Status Module #### Completion Date **Date:** 2005-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-08-08 **Type:** ESTIMATED **Last Update Submit Date:** 2011-08-05 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2005-07 **Type:** ACTUAL #### Start Date **Date:** 2004-10 **Status Verified Date:** 2011-07 #### Study First Post Date **Date:** 2011-07-26 **Type:** ESTIMATED **Study First Submit Date:** 2011-07-24 **Study First Submit QC Date:** 2011-07-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Seoul National University Hospital #### Responsible Party **Old Name Title:** Manho Kim, MD, PhD **Old Organization:** Department of Neurology, Seoul National University Hospital ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Physiology of migraine involving renin-angiotensin systems (RAS) has been implicated. Ramipril is a broadly-used angiotensin-converting enzyme inhibitor. The investigators attempt to test the efficacy of ramipril on the prophylaxis of migraine attacks. ### Conditions Module **Conditions:** - Migraine With Hypertension **Keywords:** - migraine, - ramipril, - hypertension ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** open label single arm trial **Intervention Names:** - Drug: Ramipril **Label:** ramipril **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - ramipril **Description:** ramipril 2.5mg twice a day **Name:** Ramipril **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** headache days **Measure:** headache frequency **Time Frame:** 12 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with chronic migraine are included in this study. Migraineurs should be aged 20 to 70 years old with the ability to read and understand the self-report scales, including the headache diary, used in this study. Exclusion Criteria: 1. Medication overuse headache are excluded in this study. 2. Treatment with other ACEI or medication that may affect ARS 3. Treatment with migraine prophylactic medications or anti-hypertensive agents including β adrenergic receptor or calcium channel blockers 4. Past history of hepatic or renal dysfunction; an abnormal electrocardiography; a psychiatric disorder; a history of substance abuse; pregnancy or lactation; use of anti-psychotics, antidepressants, or anti-anxiety drugs. **Maximum Age:** 70 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Seoul National University Hospital **Zip:** 110-744 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M9351 - Name: Headache - Relevance: LOW - As Found: Unknown - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M26657 - Name: Headache Disorders, Primary - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008881 - Term: Migraine Disorders - ID: D000006973 - Term: Hypertension ### Intervention Browse Module - Ancestors - ID: D000000806 - Term: Angiotensin-Converting Enzyme Inhibitors - ID: D000011480 - Term: Protease Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000959 - Term: Antihypertensive Agents ### Intervention Browse Module - Browse Branches - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M19553 - Name: Ramipril - Relevance: HIGH - As Found: Behavioral intervention - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4134 - Name: Angiotensin-Converting Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M19609 - Name: HIV Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M14343 - Name: Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017257 - Term: Ramipril ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05600179 **Brief Title:** OCTA in Epivascular Glia After Dex Implant **Official Title:** Evaluation of Changes in Epivascular Glia Before and After Intravitreal Dexamethasone Implant : an OCT Pilot Study #### Organization Study ID Info **ID:** 0110/2022 #### Organization **Class:** OTHER **Full Name:** Federico II University ### Status Module #### Completion Date **Date:** 2022-09-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-12-08 **Type:** ACTUAL **Last Update Submit Date:** 2022-12-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-09-30 **Type:** ACTUAL #### Start Date **Date:** 2021-01-01 **Type:** ACTUAL **Status Verified Date:** 2022-12 #### Study First Post Date **Date:** 2022-10-31 **Type:** ACTUAL **Study First Submit Date:** 2022-10-26 **Study First Submit QC Date:** 2022-10-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Federico II University #### Responsible Party **Investigator Affiliation:** Federico II University **Investigator Full Name:** Gilda Cennamo **Investigator Title:** professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this prospective study was for the first time, to analyze specific morphologic features in diabetic eyes with macular oedema, such as changes of the foveal avascular zone and the presence of epivascular glia, and see how they would change after dexamethasone intravitreal implant ### Conditions Module **Conditions:** - Diabetic Retinopathy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 38 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Dexamethasone intravitreal implant **Label:** patients with diabetic macular edema #### Arm Group 2 **Label:** healthy patients ### Interventions #### Intervention 1 **Arm Group Labels:** - patients with diabetic macular edema **Description:** Dexamethasone intravitreal implant **Name:** Dexamethasone intravitreal implant **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Changes in epivascular glia after Dexamethasone implant in patients with diabetic retinopathy and inflammatory macular edema **Time Frame:** up to 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * diabetic retinopathy complicated by macular edema Exclusion Criteria: * congenital eye disorders, * previous diagnosis of other ocular diseases * history of vitreous hemorrhage **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The participans were older than 18 years with diagnosis of inflammatory diabetic macular edema glaucoma.. ### Contacts Locations Module #### Locations **Location 1:** **City:** Naples **Country:** Italy **Facility:** University of Naples "Federico II" **Zip:** 80100 ### IPD Sharing Statement Module **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000003925 - Term: Diabetic Angiopathies - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M7125 - Name: Diabetic Retinopathy - Relevance: HIGH - As Found: Diabetic Retinopathy - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M7120 - Name: Diabetic Angiopathies - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003930 - Term: Diabetic Retinopathy ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7102 - Name: Dexamethasone - Relevance: HIGH - As Found: Children - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003907 - Term: Dexamethasone ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03878979 **Brief Title:** Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN **Official Title:** Preoperative Immune Checkpoint Inhibitor Therapy for Patients With Primary Untreated or Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN) #### Organization Study ID Info **ID:** J1923 #### Organization **Class:** OTHER **Full Name:** Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins #### Secondary ID Infos **Domain:** JHM IRB **ID:** IRB00207577 **Type:** OTHER **Domain:** Bristol-Myers Squibb **ID:** CA209-9H7 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2023-10-17 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-10-17 **Type:** ACTUAL #### Start Date **Date:** 2019-07-08 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2019-03-18 **Type:** ACTUAL **Study First Submit Date:** 2019-03-15 **Study First Submit QC Date:** 2019-03-15 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Bristol-Myers Squibb #### Lead Sponsor **Class:** OTHER **Name:** Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN). **Detailed Description:** This research is being done to see if it is safe and feasible to give the investigational drugs, nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN). Patients with recurrent disease may have a limited number of sites of metastatic (spread) squamous cell carcinoma of head and neck. Another goal of this study is to learn how nivolumab impacts the immune system's ability to treat the cancer. While nivolumab is approved by the U. S. Food and Drug Administration (FDA) for the treatment of patients with metastatic SCCHN with progression on or after platinum-based chemotherapy, the word "investigational" in this context means that the study drugs are not approved by the FDA for the treatment of head and neck cancers prior to surgery and thus is still being tested in research studies. However, the FDA is allowing the use of nivolumab in this study. This study will have two arms. Cohort (arm) 1 will examine one dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN. Twelve patients will be enrolled to this arm. Cohort 2 will examine one dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred and possibly spread to distant sites, but still can be resected with one surgery. Twelve patients will be enrolled to this arm. ### Conditions Module **Conditions:** - Head and Neck Squamous Cell Carcinoma - Head and Neck Cancer - Head and Neck Cancer Metastatic ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The study will accrue to 2 cohorts, each of which consists of about 12 patients. If enrollment on 1 cohort is significantly faster, the lesser enrolling cohort number of patients may be decreased in favor of the better enrolling cohort to keep the total number of evaluable patients at 24 patients.Total of 24 patients will be accrued to the study. ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 26 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN. **Intervention Names:** - Drug: Nivolumab 480mg and surgical resection **Label:** Newly diagnosed SCCHN **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred. **Intervention Names:** - Drug: Nivolumab 480mg and surgical resection **Label:** Reccurence of SCCHN **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Newly diagnosed SCCHN - Reccurence of SCCHN **Description:** One dose of Nivolumab 480mg given four weeks prior to surgical resection. **Name:** Nivolumab 480mg and surgical resection **Other Names:** - Opdivo - ONO-4538 - BMS-936558 - MDX 1106 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Safety of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection measured by number of participants with drug related adverse events as defined by CTCAE v5.0, occurring up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer) **Measure:** Safety as measured by number of participants with drug-related adverse events **Time Frame:** Up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer) **Description:** Feasibility of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection, measured by number of participants with successful completion of preoperative treatment and proceeding to surgery without any extended treatment related delays more than \> 28 days from pre-planned day 0. **Measure:** Feasibility as measured by number of participants with successful completion of preoperative treatment and no extended treatment-related delays **Time Frame:** Up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer) #### Secondary Outcomes **Description:** Number of participants with \< 10% residual tumor in the resection specimen. **Measure:** Major pathologic response rate **Time Frame:** Day 0 (after surgery) **Description:** Number of months until radiologic or clinical progression or death, whichever occurs first. **Measure:** Progression free survival (PFS) **Time Frame:** up to 3 years **Description:** Number of participants with response as determined by RECIST version 1.1 and immune-related response criteria (irRC). Per RECIST criteria, Complete response (CR) is a disappearance of all target lesions, Partial response (PR) is \>= 30% decrease in the sum of the largest diameter (LD) of target lesions, Progressive disease (PD) is \>= 20% increase in the sum of the LD of target lesions. Per irRC, immune-related Complete Response (irCR) is the disappearance of all lesions, measured or unmeasured, and no new lesions; an immune-related Partial Response (irPR) is a 50% drop in tumour burden from baseline as defined by the irRC; and immune-related Progressive Disease (irPD) is a 25% increase in tumour burden from the lowest level recorded. **Measure:** Radiographic response rate **Time Frame:** up to 4 weeks post-intervention ### Eligibility Module **Eligibility Criteria:** Inclusion: Cohort 1: Subjects must have histologically confirmed previously untreated squamous cell carcinoma of the head and neck which is amenable to surgical resection as part of standard of care. Cohort 2: Subjects must have histologically confirmed recurrent squamous cell carcinoma of head and neck, which is amenable for salvage surgery. Sites of recurrence may either be locoregional or distant if resection can be done ideally in one surgical field. * The primary site should be a head and neck squamous cell carcinoma (including, but not limited to oral cavity, oropharynx, hypopharynx, or larynx, paranasal sinuses, nasal cavity). Squamous cell carcinoma of unknown primary, diagnosed in lymph nodes in neck, can be included but should be tested for p16 and confirmed specific assay. * Subjects with oropharyngeal primary tumors must have confirmation of human papillomavirus (HPV) tumor status per clinical standards, although not necessary at enrollment. * Subjects must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist and a radiation oncologist. * Subjects must have at least one lesion that can be biopsied at baseline. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Age \>18 years. * Life expectancy of greater than 6 months. * Patients must have normal organ and marrow function as defined below: * leukocytes ≥ 1,500/ microliter (mcL) * absolute neutrophil count ≥ 1,000/mcL * platelets ≥ 100,000/mcL * total bilirubin ≤ 1.5 X institutional upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin \< 3.0 mg/dL) * AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal * Creatinine OR creatinine clearance within normal institutional limits OR ≥ 40 mL/min (using modified Cockcroft-Gault formula) for patients with creatinine levels above institutional normal. * Resting and walking O2 saturation must remain above 90% at the time of screening * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment. * Women must not be breastfeeding * Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment and for 5 months post-treatment completion. Women should use an adequate method(s) of contraception (Refer to nivolumab IB for WOCBP and methods of contraception to be provided) * Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (Refer to protocol appendix E) for the duration of treatment with study treatment(s) and 7 months post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception * Patient understands the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form. Voluntary signed and dated IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines must be obtained before the performance of any protocol related procedures that are not part of normal patient care. Subjects must be competent to report adverse events (AEs), understand the drug dosing schedule and use of medications to control AEs. * Measurable disease - either radiologically (per RECIST) or clinically measurable on exam in order to assess treatment response. Exclusion Criteria * Any active history of a known autoimmune disease. Subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * Patients who have had prior chemotherapy for newly diagnosed (cohort 1) or recurrent (cohort 2) head and neck cancer. In cohort 2 only, previous perioperative chemotherapy or chemoradiation for the management of localized or locally advanced disease permitted. * Patients who had prior surgical resection of distant metastasis (metastatectomy) within 3 months of enrollment. * Patients who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti CD137, anti-CTLA-4 antibody therapies, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. Any live / attenuated vaccine (eg varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella (MMR)) during treatment and until 100 days post last dose. * Patients with uncontrolled brain metastases * Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks without the use of steroids or on stable or decreasing dose of \< 10mg daily prednisone (or equivalent), and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of carcinomatous meningitis are not eligible. * Patients who have an active concurrent malignancy that is not controlled/cured and could impact life expectancy within the next 3 years. E.g. patients with localized cutaneous squamous cell carcinoma or basal cell carcinoma or treated prostate cancer with no evidence of disease progression may be allowed to enroll after review by the study team. * Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, administration of live vaccination in the prior 3 months, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, myocardial infarction or new onset angina within six months of enrollment, or psychiatric illness/social situations that would limit compliance with study requirements. * Women who are pregnant or nursing. * Men with female partners who are not willing to use contraception. * Active infection with hepatitis B or hepatitis C. * Patients with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids and adrenal replacement steroid doses \< 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * Patients Epstein-Barr virus + (EBV+) with nasopharynx carcinoma * Patient with HIV are excluded given the unknown risk of interaction with HAART and the unknown benefit of immunotherapy in this population. * Participants who have received a live / attenuated vaccine within 30 days of first treatment. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Baltimore **Country:** United States **Facility:** Johns Hopkins Sidney Kimmel Comprehensive Cancer Center **State:** Maryland **Zip:** 21287 #### Overall Officials **Official 1:** **Affiliation:** Johns Hopkins University **Name:** Tanguy Lim-Seiwert, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000009371 - Term: Neoplasms by Site ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: HIGH - As Found: Head and Neck Cancer - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Carcinoma - ID: M1689 - Name: Squamous Cell Carcinoma of Head and Neck - Relevance: HIGH - As Found: Head and Neck Squamous Cell Carcinoma - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000077195 - Term: Squamous Cell Carcinoma of Head and Neck ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1854 - Name: Nivolumab - Relevance: HIGH - As Found: Prospective - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077594 - Term: Nivolumab ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04175379 **Brief Title:** The Effect of Permissive Hypercapnia on Oxygenation and Post-operative Pulmonary Complication During One-lung Ventilation **Official Title:** The Effect of Permissive Hypercapnia on Oxygenation and Post-operative Pulmonary Complication During One-lung Ventilation : Prospective, Randomized Controlled Study #### Organization Study ID Info **ID:** 4-2019-0904 #### Organization **Class:** OTHER **Full Name:** Yonsei University ### Status Module #### Completion Date **Date:** 2021-10 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** ENROLLING_BY_INVITATION #### Last Update Post Date **Date:** 2020-01-02 **Type:** ACTUAL **Last Update Submit Date:** 2019-12-30 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2021-08 **Type:** ESTIMATED #### Start Date **Date:** 2019-11-25 **Type:** ACTUAL **Status Verified Date:** 2019-12 #### Study First Post Date **Date:** 2019-11-25 **Type:** ACTUAL **Study First Submit Date:** 2019-11-15 **Study First Submit QC Date:** 2019-11-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Yonsei University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Permissive hypercapnia increased the survival rate in patients with acute respiratory distress syndrome (ARDS) who required mechanical ventilation in critical care medicine. This has been explained by its association with ventilator induced lung injury. Since then, a protective lung ventilation strategy has been very important, with a low tidal volume of 4-6 ml/kg. Patients undergoing surgery will inevitably require mechanical ventilation. In particular, patients undergoing one lung ventilation for thoracic surgery may have increased airway pressure and a greater chance of ventilator induced lung injury. Recently, protective lung ventilation has been applied to patients undergoing one ung ventilation during thoracic surgery. The purpose of this study is to evaluate the difference in the degree of pulmonary oxygenation and the incidence of postoperative pulmonary complications in hypercapnia induced by controlling the respiratory rate with a constant tidal volume. ### Conditions Module **Conditions:** - Thoracic Surgery ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Random sampling using random numbers is divided into three groups, and the ratio of each group is 1: 1: 1. ##### Masking Info **Masking:** TRIPLE **Masking Description:** Patients, care givers and outcomes assessors are blinded. The investigator should not be included in the blind because they need to adjust the ventilator settings. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 279 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In group 40, target PaCO2 is 40 during surgery **Intervention Names:** - Other: group 40 **Label:** group 40 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In group 50, target PaCO2 is 50 during surgery **Intervention Names:** - Other: group 50 **Label:** group 50 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** In group 60, target PaCO2 is 60 during surgery **Intervention Names:** - Other: group 60 **Label:** group 60 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - group 40 **Description:** During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 40 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2). **Name:** group 40 **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - group 50 **Description:** During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 50 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2). **Name:** group 50 **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - group 60 **Description:** During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 60 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2). **Name:** group 60 **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** (arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2 (PaO2 of ABGA/FiO2) T2 **Measure:** PaO2/FiO2 ratio **Time Frame:** about 60 minutes after reaching to the target PaCO2 (T2) #### Secondary Outcomes **Description:** desaturation event (\<90%) the first 3 days after surgery **Measure:** Post-op complication: desaturation event **Time Frame:** first 3 days after surgery **Description:** necessity of oxygen therapy within the first 2\~7 days after surgery hospitalized days, ICU days, expire **Measure:** Post-op complication: oxygen therapy **Time Frame:** first 2~7 days after surgery **Description:** The presence or absence of post operative complication like pneumonia, acute lung injury, re-intubation, ICU admission, ventilator care, empyema, broncho-pleura fistula, air-leakage, pleural effusion, pulmonary embolism, tracheostomy, wound infection, AKI, MI, etc. **Measure:** Post-op complication **Time Frame:** 30 days after surgery **Description:** length of hospitalized stays CU days, expire **Measure:** Post-op complication: hospitalized days **Time Frame:** 30 days after surgery **Description:** length of ICU stays **Measure:** Post-op complication: ICU days **Time Frame:** 30 days after surgery **Description:** patient has been dead or not **Measure:** Dead **Time Frame:** 30 days after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adult patients aged 40-80 years who are planning to have thoracoscopic single lobectomy or segmentectomy with one lung ventilation during surgery. 2. American Society of Anesthesiologists (ASA) classification 1\~3 Exclusion Criteria: 1. patients with heart failure (NYHA class III\~IV) 2. patients who are having moderate obstructive lung disease or restrictive lung disease 3. Low DLCO (\< 75%) 4. patients with brain disease history or increased ICP 5. patients with pulmonary hypertension (mean PAP\>25mmHg) 6. patients with liver disease (AST level ≥100 IU/mL or ALT ≥ level 50 IU/L) or kidney disease (Creatine level ≥ 1.5 mg/dL) 7. patients with pre-existing hypercapnia or metabolic acidosis 8. body mass index (BMI) \> 30 kg/m2 9. patients who have had contralateral lung surgery 10. patients who cannot read explanation and consent form 11. patients who are pregnant **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine **Zip:** 03722 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012818 - Term: Signs and Symptoms, Respiratory ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9986 - Name: Hypercapnia - Relevance: HIGH - As Found: Hypercapnia - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006935 - Term: Hypercapnia ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03058679 **Acronym:** DINE-CD **Brief Title:** Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease **Official Title:** Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease #### Organization Study ID Info **ID:** 825907 #### Organization **Class:** OTHER **Full Name:** University of Pennsylvania ### Status Module #### Completion Date **Date:** 2020-03-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-07-21 **Type:** ACTUAL **Last Update Submit Date:** 2021-06-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-03-01 **Type:** ACTUAL #### Results First Post Date **Date:** 2021-07-21 **Type:** ACTUAL **Results First Submit Date:** 2021-03-26 **Results First Submit QC Date:** 2021-06-30 #### Start Date **Date:** 2017-09-29 **Type:** ACTUAL **Status Verified Date:** 2021-06 #### Study First Post Date **Date:** 2017-02-23 **Type:** ACTUAL **Study First Submit Date:** 2017-02-16 **Study First Submit QC Date:** 2017-02-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Patient-Centered Outcomes Research Institute **Class:** OTHER **Name:** Crohn's and Colitis Foundation **Class:** OTHER **Name:** University of North Carolina, Chapel Hill #### Lead Sponsor **Class:** OTHER **Name:** University of Pennsylvania #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This protocol is designed to compare the effectiveness of two dietary interventions for patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean style diet (MSD) that has been demonstrated to have numerous other health benefits. The two diets will be compared in terms of their ability to resolve both the symptoms and bowel inflammation that characterize this debilitating disease. **Detailed Description:** This study tested whether the SCD is superior to a MSD for managing symptoms and reducing inflammatory markers in patients with CD. The study was designed to include 194 patients with CD who have 1) active symptoms defined by a short Crohn's Disease Activity Index (sCDAI) score \>175. Although the initial plan was to also require that all patients have active inflammation documented by a fecal calprotectin (FCP) concentration \>250mcg/g or high sensitivity C-reactive protein (CRP) \>7 mg/L or ulceration of the small bowel and/or colon consistent with an SES-CD score \>4 as documented in routine clinical practice within 4 weeks of screening, a decision was made early in the recruitment period to enroll all patients with CD with sCDAI\>175 regardless of the results of the tests for inflammatory markers and to perform subgroup analyses of those with and without evidence of inflammation. Eligible participants were randomly assigned to follow one of the diets in a 1:1 ratio. Participants were provided with 3 meals and 2 snacks each day for a period of 6 weeks. The meals and snacks were prepared by the food vendor, Healthy Chef Creations, and were delivered directly to the participant's home once per week. Participants in both groups were also provided with instructions on how to follow the diets on their own. Participants reported their symptoms through an electronic diary and provided stool samples for FCP measurement and blood for CRP measurement at weeks 0, 6 and 12. The primary and secondary outcomes were assessed at week 6. Following week 6, participants were able to pay out of pocket to purchase food from Healthy Chef Creations and/or could attempt to follow their assigned diet completely on their own. At week 12, in addition to the primary and secondary outcomes assessed again ### Conditions Module **Conditions:** - Crohn Disease **Keywords:** - diet - specific carbohydrate diet - Mediterranean style diet - randomized controlled trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 197 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** For the first six 6 weeks of the trial, participants received a weekly delivery of prepared meals compliant with the SCD (breakfast, lunch, dinner, and two 2 snacks per day). Meals were prepared by Healthy Chef Creations (Orlando, FL) based on menus developed by the food vendor in consultation with study dietitians. Participants assigned to the SCD received a three3-day starter diet as recommended in Breaking the Vicious Cycle. Meals were designed to be heated in an oven or microwave. No other preparation was required. **Intervention Names:** - Other: Diet **Label:** Specific Carbohydrate Diet **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** For the first six 6 weeks of the trial, participants received a weekly delivery of prepared meals compliant with the MD (breakfast, lunch, dinner, and two 2 snacks per day). Meals were prepared by Healthy Chef Creations (Orlando, FL) based on menus developed by the food vendor in consultation with study dietitians. Meals were designed to be heated in an oven or microwave. No other preparation was required. **Intervention Names:** - Other: Diet **Label:** Mediterranean Style Diet **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Mediterranean Style Diet - Specific Carbohydrate Diet **Description:** food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks **Name:** Diet **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI \<150 in the absence of initiation or increase of any CD medications **Measure:** Percentage of Participants That Achieved Symptomatic Remission at Week 6 **Time Frame:** 6 weeks **Description:** reduction of calprotectin to less than 250 μg/g and by greater than 50% from screening among those with screening FC \>250 μg/g **Measure:** Reduction in Bowel Inflammation Among Those Whose Screening Fecal Calprotectin (FC) Was Greater Than 250μg/g at Baseline and Who Had an FC Results at Both Baseline and Week 6 **Time Frame:** 6 weeks #### Secondary Outcomes **Description:** Assessed by the CDAI - CDAI \<150 **Measure:** Percentage of Participants That Reached Clinical Remission at Week 6 **Time Frame:** 6 weeks **Description:** reduction in high-sensitivity CRP (hsCRP) to \<5 mg/L and \>50% reduction from screening among those with screening hsCRP \>5mg/L **Measure:** Percentage of Participants With a Reduction in Systemic Inflammation at Week 6 **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria 1. Age ≥18 2. Documented diagnosis of Crohn's disease 3. sCDAI score \>175 4. Documentation of receipt of a baseline stool sample by the data coordinating center and hsCRP. 5. Access to a computer with internet and the ability to complete daily online surveys 6. Capable of providing consent to participate 7. Able to receive weekly food shipments delivered every Friday for 6 weeks Exclusion Criteria 1. Pregnancy 2. sCDAI \>400 3. Hospitalized patients 4. Anticipated need for surgery within 6 weeks of randomization 5. Use of the Specific Carbohydrate Diet within 4 weeks of screening 6. Start or change\*\*\* dose of thiopurines (azathioprine and 6-MP), methotrexate, natalizumab, or vedolizumab within 12 weeks prior to screening 7. Start or change\*\*\* dose of anti-tumor necrosis factor (TNF) agents (including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), golimumab (Simponi) or ustekinumab within 8 weeks prior to screening. 8. Start or change in dose of any 5-aminosalicylic acid (5-ASA) medications within 2 weeks of screening. 9. Start or change dose of corticosteroids within 1 week of screening or a dose \>20mg/day prednisone or equivalent\* 10. Use of antibiotics (other than topical formulations) for any reason within 2 weeks prior to screening 11. Known symptomatic intestinal stricture. 12. Presence of an ostomy 13. Baseline stool frequency \>4 bowel movements/day when well 14. BMI \<16 15. BMI ≥40 16. Celiac disease 17. Documented C difficile colitis within four weeks of screening 18. Diabetes Mellitus requiring medication 19. Albumin\<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care) 20. Known allergy to tree nuts or peanuts 21. Other conditions that would be a contraindication to any of the study diets or preclude the participant from completing the study. 22. Currently participating in another clinical trial of a drug to treat Inflammatory Bowel Disease (IBD) or a dietary therapy for any indication. * Patients may continue these medications at stable dose for the first six weeks and budesonide may be used at any dose. After the 6th week in the study, patients may taper their steroid dose. The study will provide a recommended taper schedule. * Loading/induction doses of biologic type medication will be considered a stable doses. \*\*\*Exception for treatment failures: if a subject is determined to fail on any of the following standard lines of treatment at the treating investigator's discretion, subjects may screen for study intervention based upon the following wash out periods: 4 weeks for thiopurine and methotrexate and 8 weeks for natalizumab, vedolizumab, anti-TNF, or ustekinumab. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tucson **Country:** United States **Facility:** University of Arizona **State:** Arizona **Zip:** 85724 **Location 2:** **City:** San Francisco **Country:** United States **Facility:** UCSF Colitis and Crohn's Disease Center **State:** California **Zip:** 94115 **Location 3:** **City:** Denver **Country:** United States **Facility:** University of Colorado Denver **State:** Colorado **Zip:** 80204 **Location 4:** **City:** Atlanta **Country:** United States **Facility:** Emory University **State:** Georgia **Zip:** 30322 **Location 5:** **City:** Atlanta **Country:** United States **Facility:** Atlanta Gastroenterology **State:** Georgia **Zip:** 30342 **Location 6:** **City:** Chicago **Country:** United States **Facility:** University of Chicago **State:** Illinois **Zip:** 60614 **Location 7:** **City:** Evanston **Country:** United States **Facility:** NorthShore University HealthSystem **State:** Illinois **Zip:** 60201 **Location 8:** **City:** Evanston **Country:** United States **Facility:** Northwestern University **State:** Illinois **Zip:** 60208 **Location 9:** **City:** Indianapolis **Country:** United States **Facility:** Indiana University Health University Hospital **State:** Indiana **Zip:** 46202 **Location 10:** **City:** Louisville **Country:** United States **Facility:** The University of Louisville **State:** Kentucky **Zip:** 40202 **Location 11:** **City:** Baltimore **Country:** United States **Facility:** University of Maryland Baltimore **State:** Maryland **Zip:** 21201 **Location 12:** **City:** Boston **Country:** United States **Facility:** Boston Children's Hospital **State:** Massachusetts **Zip:** 02115 **Location 13:** **City:** Chesterfield **Country:** United States **Facility:** Clinical Research Institute of Michigan **State:** Michigan **Zip:** 48047 **Location 14:** **City:** Troy **Country:** United States **Facility:** Troy Gastroenterology **State:** Michigan **Zip:** 48092 **Location 15:** **City:** Minneapolis **Country:** United States **Facility:** The University of Minnesota **State:** Minnesota **Zip:** 55455 **Location 16:** **City:** Plymouth **Country:** United States **Facility:** Minnesota Gastroenterology, P.A **State:** Minnesota **Zip:** 55446 **Location 17:** **City:** Rochester **Country:** United States **Facility:** Mayo Clinic - Rochester **State:** Minnesota **Zip:** 55905 **Location 18:** **City:** Lebanon **Country:** United States **Facility:** Dartmouth-Hitchcock Medical Center **State:** New Hampshire **Zip:** 03756 **Location 19:** **City:** New York **Country:** United States **Facility:** NYU Langone Medical Center **State:** New York **Zip:** 10016 **Location 20:** **City:** New York **Country:** United States **Facility:** Weill Cornell - NewYork Presbyterian **State:** New York **Zip:** 10021 **Location 21:** **City:** New York **Country:** United States **Facility:** Icahn School of Medicine at Mount Sinai **State:** New York **Zip:** 10029 **Location 22:** **City:** New York **Country:** United States **Facility:** Lenox Hill Hospital **State:** New York **Zip:** 10075 **Location 23:** **City:** Chapel Hill **Country:** United States **Facility:** The University of North Carolina **State:** North Carolina **Zip:** 27599 **Location 24:** **City:** Charlotte **Country:** United States **Facility:** Atrium Health (formerly Carolinas HealthCare System) **State:** North Carolina **Zip:** 28203 **Location 25:** **City:** Winston-Salem **Country:** United States **Facility:** Wake Forest Baptist Medical Center **State:** North Carolina **Zip:** 27157 **Location 26:** **City:** Cincinnati **Country:** United States **Facility:** University of Cincinnati **State:** Ohio **Zip:** 45267 **Location 27:** **City:** Cleveland **Country:** United States **Facility:** University Hospitals Cleveland Medical Center **State:** Ohio **Zip:** 44106 **Location 28:** **City:** Columbus **Country:** United States **Facility:** Ohio State University - Wexner Medical Center **State:** Ohio **Zip:** 43210 **Location 29:** **City:** Philadelphia **Country:** United States **Facility:** University of Pennsylvania **State:** Pennsylvania **Zip:** 19104 **Location 30:** **City:** Pittsburgh **Country:** United States **Facility:** University of Pittsburgh Medical Center **State:** Pennsylvania **Zip:** 15213 **Location 31:** **City:** Providence **Country:** United States **Facility:** Lifespan Health System **State:** Rhode Island **Zip:** 02903 **Location 32:** **City:** Nashville **Country:** United States **Facility:** Vanderbilt University Medical Center **State:** Tennessee **Zip:** 37232 **Location 33:** **City:** Salt Lake City **Country:** United States **Facility:** University of Utah **State:** Utah **Zip:** 84112 **Location 34:** **City:** Seattle **Country:** United States **Facility:** Virginia Mason Medical Center **State:** Washington **Zip:** 98101 **Location 35:** **City:** Madison **Country:** United States **Facility:** University of Wisconsin-Madison **State:** Wisconsin **Zip:** 53706 #### Overall Officials **Official 1:** **Affiliation:** University of Pennsylvania **Name:** James D Lewis, MD, MSCE **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Lewis JD, Sandler RS, Brotherton C, Brensinger C, Li H, Kappelman MD, Daniel SG, Bittinger K, Albenberg L, Valentine JF, Hanson JS, Suskind DL, Meyer A, Compher CW, Bewtra M, Saxena A, Dobes A, Cohen BL, Flynn AD, Fischer M, Saha S, Swaminath A, Yacyshyn B, Scherl E, Horst S, Curtis JR, Braly K, Nessel L, McCauley M, McKeever L, Herfarth H; DINE-CD Study Group. A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease. Gastroenterology. 2021 Sep;161(3):837-852.e9. doi: 10.1053/j.gastro.2021.05.047. Epub 2021 May 27. Erratum In: Gastroenterology. 2022 Nov;163(5):1473. **PMID:** 34052278 ## Document Section ### Large Document Module #### Large Docs - Date: 2019-04-10 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 1727953 - Type Abbrev: Prot_SAP - Upload Date: 2020-12-23T10:06 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000015212 - Term: Inflammatory Bowel Diseases - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000007410 - Term: Intestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6638 - Name: Crohn Disease - Relevance: HIGH - As Found: Crohn's Disease - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M17917 - Name: Inflammatory Bowel Diseases - Relevance: LOW - As Found: Unknown - ID: M8875 - Name: Gastroenteritis - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003424 - Term: Crohn Disease ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow). #### Event Groups **Group ID:** EG000 **Title:** Mediterranean Style Diet **Deaths Num At Risk:** 92 **Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks **ID:** EG000 **Other Num Affected:** 18 **Other Num at Risk:** 92 **Serious Number Affected:** 5 **Serious Number At Risk:** 92 **Title:** Mediterranean Style Diet **Group ID:** EG001 **Title:** Specific Carbohydrate Diet **Deaths Num At Risk:** 99 **Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks **ID:** EG001 **Other Num Affected:** 19 **Other Num at Risk:** 99 **Serious Number Affected:** 3 **Serious Number At Risk:** 99 **Title:** Specific Carbohydrate Diet **Frequency Threshold:** 5 #### Other Events **Term:** Abdominal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Gastrointestingal disorders other - Worsening of Crohn's disease symptons **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) #### Serious Events **Term:** Small intestinal obstruction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 92 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 99 **Num Events:** 1 **Term:** Abdominal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 92 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 99 **Num Events:** 3 **Term:** Worsening of Crohn's disease **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) ##### Stats **Group ID:** EG000 **Num At Risk:** 92 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 99 **Num Events:** 2 **Term:** Rectal hemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 92 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 99 **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 92 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 99 **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 92 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 99 **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 92 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 99 **Time Frame:** AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 92 **Group ID:** BG001 **Value:** 99 **Group ID:** BG002 **Value:** 191 **Units:** Participants ### Group **ID:** BG000 **Title:** Mediterranean Style Diet **Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks ### Group **ID:** BG001 **Title:** Specific Carbohydrate Diet **Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 29.5 **Upper Limit:** 53.0 **Value:** 37.0 #### Measurement **Group ID:** BG001 **Lower Limit:** 27.0 **Upper Limit:** 46.0 **Value:** 36.0 #### Measurement **Group ID:** BG002 **Lower Limit:** 28.0 **Upper Limit:** 50.0 **Value:** 37 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 63 #### Measurement **Group ID:** BG001 **Value:** 58 #### Measurement **Group ID:** BG002 **Value:** 121 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 29 #### Measurement **Group ID:** BG001 **Value:** 41 #### Measurement **Group ID:** BG002 **Value:** 70 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 8 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 88 #### Measurement **Group ID:** BG001 **Value:** 92 #### Measurement **Group ID:** BG002 **Value:** 180 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 3 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 7 **Category Title:** Black #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Multiracial #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 4 **Category Title:** Other #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Unknown #### Measurement **Group ID:** BG000 **Value:** 86 #### Measurement **Group ID:** BG001 **Value:** 88 #### Measurement **Group ID:** BG002 **Value:** 174 **Category Title:** White **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 21.3 **Upper Limit:** 29.9 **Value:** 25.1 #### Measurement **Group ID:** BG001 **Lower Limit:** 22.5 **Upper Limit:** 29.0 **Value:** 25.6 #### Measurement **Group ID:** BG002 **Lower Limit:** 21.8 **Upper Limit:** 29.5 **Value:** 25.3 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 68 #### Measurement **Group ID:** BG001 **Value:** 79 #### Measurement **Group ID:** BG002 **Value:** 147 **Category Title:** Never #### Measurement **Group ID:** BG000 **Value:** 21 #### Measurement **Group ID:** BG001 **Value:** 20 #### Measurement **Group ID:** BG002 **Value:** 41 **Category Title:** Past #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 3 **Category Title:** Current **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 5 **Upper Limit:** 21 **Value:** 10 #### Measurement **Group ID:** BG001 **Lower Limit:** 3 **Upper Limit:** 16 **Value:** 10 #### Measurement **Group ID:** BG002 **Lower Limit:** 4 **Upper Limit:** 17 **Value:** 10 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 56 #### Measurement **Group ID:** BG001 **Value:** 60 #### Measurement **Group ID:** BG002 **Value:** 116 **Category Title:** Non-stricturing, nonpenetrating #### Measurement **Group ID:** BG000 **Value:** 19 #### Measurement **Group ID:** BG001 **Value:** 17 #### Measurement **Group ID:** BG002 **Value:** 36 **Category Title:** Stricturing #### Measurement **Group ID:** BG000 **Value:** 9 #### Measurement **Group ID:** BG001 **Value:** 13 #### Measurement **Group ID:** BG002 **Value:** 22 **Category Title:** Penetrating #### Measurement **Group ID:** BG000 **Value:** 8 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 17 **Category Title:** Stricturing and penetrating **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 22 #### Measurement **Group ID:** BG001 **Value:** 30 #### Measurement **Group ID:** BG002 **Value:** 52 **Category Title:** Ileum alone #### Measurement **Group ID:** BG000 **Value:** 17 #### Measurement **Group ID:** BG001 **Value:** 13 #### Measurement **Group ID:** BG002 **Value:** 30 **Category Title:** Colon alone #### Measurement **Group ID:** BG000 **Value:** 53 #### Measurement **Group ID:** BG001 **Value:** 55 #### Measurement **Group ID:** BG002 **Value:** 108 **Category Title:** Ileum and Colon #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** Missing **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 24 #### Measurement **Group ID:** BG001 **Value:** 20 #### Measurement **Group ID:** BG002 **Value:** 44 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 34 #### Measurement **Group ID:** BG001 **Value:** 29 #### Measurement **Group ID:** BG002 **Value:** 63 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 55 #### Measurement **Group ID:** BG001 **Value:** 53 #### Measurement **Group ID:** BG002 **Value:** 108 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 11 #### Measurement **Group ID:** BG001 **Value:** 11 #### Measurement **Group ID:** BG002 **Value:** 22 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 15 #### Measurement **Group ID:** BG002 **Value:** 21 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 3 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 11 #### Measurement **Group ID:** BG002 **Value:** 14 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 3 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 28 #### Measurement **Group ID:** BG001 **Value:** 34 #### Measurement **Group ID:** BG002 **Value:** 62 **Category Title:** 0 #### Measurement **Group ID:** BG000 **Value:** 22 #### Measurement **Group ID:** BG001 **Value:** 29 #### Measurement **Group ID:** BG002 **Value:** 51 **Category Title:** 1 #### Measurement **Group ID:** BG000 **Value:** 32 #### Measurement **Group ID:** BG001 **Value:** 26 #### Measurement **Group ID:** BG002 **Value:** 58 **Category Title:** 2 #### Measurement **Group ID:** BG000 **Value:** 9 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 18 **Category Title:** 3 #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** 4 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 22 #### Measurement **Group ID:** BG001 **Value:** 23 #### Measurement **Group ID:** BG002 **Value:** 45 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 27 #### Measurement **Group ID:** BG001 **Value:** 22 #### Measurement **Group ID:** BG002 **Value:** 49 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 1.2 **Upper Limit:** 6.2 **Value:** 2.5 #### Measurement **Group ID:** BG001 **Lower Limit:** 1.4 **Upper Limit:** 8.1 **Value:** 3.2 #### Measurement **Group ID:** BG002 **Lower Limit:** 1.4 **Upper Limit:** 7.5 **Value:** 2.9 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 28 #### Measurement **Group ID:** BG001 **Value:** 37 #### Measurement **Group ID:** BG002 **Value:** 65 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 16.0 **Upper Limit:** 185.0 **Value:** 40.0 #### Measurement **Group ID:** BG001 **Lower Limit:** 16.0 **Upper Limit:** 223.0 **Value:** 107.5 #### Measurement **Group ID:** BG002 **Lower Limit:** 16.0 **Upper Limit:** 194.0 **Value:** 70 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 13 #### Measurement **Group ID:** BG001 **Value:** 23 #### Measurement **Group ID:** BG002 **Value:** 36 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 80 #### Measurement **Group ID:** BG001 **Value:** 89 #### Measurement **Group ID:** BG002 **Value:** 169 **Category Title:** Not performed #### Measurement **Group ID:** BG000 **Value:** 8 #### Measurement **Group ID:** BG001 **Value:** 8 #### Measurement **Group ID:** BG002 **Value:** 16 **Category Title:** Yes #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** Probably #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Probably not #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 3 **Category Title:** No **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 38 #### Measurement **Group ID:** BG001 **Value:** 50 #### Measurement **Group ID:** BG002 **Value:** 88 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 195.7 **Upper Limit:** 247.0 **Value:** 217.7 #### Measurement **Group ID:** BG001 **Lower Limit:** 197.0 **Upper Limit:** 263.8 **Value:** 226.0 #### Measurement **Group ID:** BG002 **Lower Limit:** 195.7 **Upper Limit:** 259.6 **Value:** 223.0 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 179.3 **Upper Limit:** 247.0 **Value:** 206.8 #### Measurement **Group ID:** BG001 **Lower Limit:** 169.8 **Upper Limit:** 246.2 **Value:** 210.0 #### Measurement **Group ID:** BG002 **Lower Limit:** 171.5 **Upper Limit:** 246.2 **Value:** 209.5 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 33.0 **Upper Limit:** 44.0 **Value:** 38.0 #### Measurement **Group ID:** BG001 **Lower Limit:** 33.0 **Upper Limit:** 45.0 **Value:** 40.0 #### Measurement **Group ID:** BG002 **Lower Limit:** 33.0 **Upper Limit:** 45.0 **Value:** 39.0 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 55.9 **Upper Limit:** 65.9 **Value:** 60.4 #### Measurement **Group ID:** BG001 **Lower Limit:** 54.8 **Upper Limit:** 65.6 **Value:** 58.9 #### Measurement **Group ID:** BG002 **Lower Limit:** 55.0 **Upper Limit:** 65.8 **Value:** 59.6 **Class Title:** Fatigue #### Measurement **Group ID:** BG000 **Lower Limit:** 55.7 **Upper Limit:** 63.8 **Value:** 60.1 #### Measurement **Group ID:** BG001 **Lower Limit:** 55.7 **Upper Limit:** 63.6 **Value:** 61.3 #### Measurement **Group ID:** BG002 **Lower Limit:** 55.7 **Upper Limit:** 63.7 **Value:** 61.2 **Class Title:** Pain interference #### Measurement **Group ID:** BG000 **Lower Limit:** 51.4 **Upper Limit:** 62.1 **Value:** 57.3 #### Measurement **Group ID:** BG001 **Lower Limit:** 49.4 **Upper Limit:** 60.2 **Value:** 54.5 #### Measurement **Group ID:** BG002 **Lower Limit:** 50.9 **Upper Limit:** 61.4 **Value:** 56.0 **Class Title:** Sleep disturbance #### Measurement **Group ID:** BG000 **Lower Limit:** 41.0 **Upper Limit:** 56.1 **Value:** 48.4 #### Measurement **Group ID:** BG001 **Lower Limit:** 34.8 **Upper Limit:** 53.8 **Value:** 47.2 #### Measurement **Group ID:** BG002 **Lower Limit:** 34.8 **Upper Limit:** 54.5 **Value:** 47.9 **Class Title:** Social isolation ### Measure #### Measurement **Group ID:** BG000 **Value:** 30 #### Measurement **Group ID:** BG001 **Value:** 40 #### Measurement **Group ID:** BG002 **Value:** 70 **Category Title:** 0 #### Measurement **Group ID:** BG000 **Value:** 39 #### Measurement **Group ID:** BG001 **Value:** 40 #### Measurement **Group ID:** BG002 **Value:** 79 **Category Title:** 1-3 #### Measurement **Group ID:** BG000 **Value:** 22 #### Measurement **Group ID:** BG001 **Value:** 18 #### Measurement **Group ID:** BG002 **Value:** 40 **Category Title:** >3 #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Missing **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 1.0 **Upper Limit:** 4.0 **Value:** 3.0 #### Measurement **Group ID:** BG001 **Lower Limit:** 1.0 **Upper Limit:** 3.0 **Value:** 2.0 #### Measurement **Group ID:** BG002 **Lower Limit:** 2.0 **Upper Limit:** 4.0 **Value:** 3.0 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race/Ethnicity, Customized **Unit of Measure:** Participants ### Measure 5 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Body Mass Index (BMI) **Unit of Measure:** kg/m2 ### Measure 6 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Smoking status **Unit of Measure:** Participants ### Measure 7 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Years since CD diagnosis **Unit of Measure:** years ### Measure 8 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** CD behavior **Unit of Measure:** Participants ### Measure 9 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Crohn's disease distribution **Unit of Measure:** Participants ### Measure 10 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** History of perianal fistula **Unit of Measure:** Participants ### Measure 11 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** History of intestinal surgery **Unit of Measure:** Participants ### Measure 12 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Current use of any biologic **Unit of Measure:** Participants ### Measure 13 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Current use of immunomodulators **Unit of Measure:** Participants ### Measure 14 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Current use of oral 5-ASA **Unit of Measure:** Participants ### Measure 15 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Current use of rectal 5 ASA **Unit of Measure:** Participants ### Measure 16 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Current use of oral steroids **Unit of Measure:** Participants ### Measure 17 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Current use of rectal steroids **Unit of Measure:** Participants ### Measure 18 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Number of prior anti-TNF medications **Unit of Measure:** Participants ### Measure 19 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Prior ustekinumab **Unit of Measure:** Participants ### Measure 20 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Prior vedolizumab **Unit of Measure:** Participants ### Measure 21 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** hsCRP mg/L **Unit of Measure:** mg/L ### Measure 22 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** hsCRP >5 mg/L **Unit of Measure:** Participants ### Measure 23 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** fecal calprotectin (FC) ug/g **Unit of Measure:** ug/g ### Measure 24 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** fecal calprotectin (FC) >250 ug/g **Unit of Measure:** Participants ### Measure 25 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Inflammation on colonoscopy **Unit of Measure:** Participants ### Measure 26 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** FC>250 ug/g or hsCRP>5 mg/L or definite inflammation on colonoscopy **Unit of Measure:** Participants ### Measure 27 **Description:** Short Crohn's Disease Activity Index. This is a method to measure Crohn's disease patient's symptoms using only a questionnaire,which can be completed without an office visit or lab work. The variables included in the short CDAI are abdominal pain, diarrhea frequency, and general well-being. The higher the score, the worse the disease activity. The sCDAI uses the same scale as the full CDAI, such that scores,\<150 define remission, 150 to 219 mild activity, 220 to450 moderate activity, and.450 severe activity. The total score is reported. **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** sCDAI (median, Q1-Q3) **Unit of Measure:** units on a scale ### Measure 28 **Description:** The Crohn's Disease Activity Index - CDAI scores range from 0 to 600. A score of less than 150 denotes relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. The higher the score, the worse the disease activity. This index uses the following variables to determine a score: number of stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit, and body weight **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** CDAI (median, Q1-Q3) **Unit of Measure:** units on a scale ### Measure 29 **Description:** The SIBDQ is a 10-item health-related quality of life (HRQOL) questionnaire validated for use in CD patients. It assesses physical, social, and emotional status and is scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). Scores for each question are summed to provide a total score. The total score is reported. The absolute score ranges from 10 (poor HRQOL) to 70 (optimum HRQOL). **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Short IBDQ (median, Q1-Q3) **Unit of Measure:** units on a scale ### Measure 30 **Description:** Patient-Reported Outcomes Measurement Information System (PROMIS)- set of person-centered measures that evaluate and monitor health status. All assessments are for the last 7 days. To calculate a total raw score, each item is scored on a scale of 1-5. If the form has 7 items, the lowest possible raw score is 7 and the highest possible raw score is 35. Raw scores are then translated into T scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. T-scores are reported. Higher T-scores denote worse outcomes. **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** PROMIS measures (median, Q1-Q3) **Unit of Measure:** units on a scale ### Measure 31 **Description:** This self-reported survey assessed five criteria defining possible inflammatory back pain:(1) improvement with exercise (2) pain at night (3) insidious onset (4) age at onset \<40 years and (5) no improvement with rest. The higher the score the more likely the person had inflammatory back pain. **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Inflammatory back pain screen **Unit of Measure:** Participants ### Measure 32 **Description:** Alternate Mediterranean Diet Score - Participants completed a 24-hour dietary recall at baseline, during week 6 and during week 12. These data were used to compute the Alternate Mediterranean Diet Score (AMeD) where a higher score implies greater consistency with a Mediterranean diet. AMeD scores range from 0 (minimal adherence) to 9 (maximal adherence). **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** AMeD Score **Unit of Measure:** units on a scale ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** University of Pennsylvania **Phone:** 215-573-5137 **Title:** Dr. James D. Lewis ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 40 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 46 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 8 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 44 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 48 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI \<150 in the absence of initiation or increase of any CD medications **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** percentage of participants who achieved symptomatic remission at week 6 **Reporting Status:** POSTED **Time Frame:** 6 weeks **Title:** Percentage of Participants That Achieved Symptomatic Remission at Week 6 **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks **ID:** OG000 **Title:** Mediterranean Style Diet ##### Group **Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks **ID:** OG001 **Title:** Specific Carbohydrate Diet #### Outcome Measure 2 **Description:** reduction of calprotectin to less than 250 μg/g and by greater than 50% from screening among those with screening FC \>250 μg/g **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** This measure includes only those whose screening fecal calprotectin (FC) was greater than 250μg/g at baseline and who had an FC results at both baseline and week 6 **Reporting Status:** POSTED **Time Frame:** 6 weeks **Title:** Reduction in Bowel Inflammation Among Those Whose Screening Fecal Calprotectin (FC) Was Greater Than 250μg/g at Baseline and Who Had an FC Results at Both Baseline and Week 6 **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks **ID:** OG000 **Title:** Mediterranean Style Diet ##### Group **Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks **ID:** OG001 **Title:** Specific Carbohydrate Diet #### Outcome Measure 3 **Description:** Assessed by the CDAI - CDAI \<150 **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** 6 weeks **Title:** Percentage of Participants That Reached Clinical Remission at Week 6 **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks **ID:** OG000 **Title:** Mediterranean Style Diet ##### Group **Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks **ID:** OG001 **Title:** Specific Carbohydrate Diet #### Outcome Measure 4 **Description:** reduction in high-sensitivity CRP (hsCRP) to \<5 mg/L and \>50% reduction from screening among those with screening hsCRP \>5mg/L **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** This measure includes only those that had a screening hsCRP \> 5mg/L and had hsCRP measured at both screening and at week 6 **Reporting Status:** POSTED **Time Frame:** 6 weeks **Title:** Percentage of Participants With a Reduction in Systemic Inflammation at Week 6 **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks **ID:** OG000 **Title:** Mediterranean Style Diet ##### Group **Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks **ID:** OG001 **Title:** Specific Carbohydrate Diet ### Participant Flow Module #### Group **Description:** Diet: food for the diet will be provided to the participants for 6 weeks **ID:** FG000 **Title:** Specific Carbohydrate Diet #### Group **Description:** Diet: food for the diet will be provided to the participants for 6 weeks **ID:** FG001 **Title:** Mediterranean Style Diet #### Period **Title:** Baseline to Week 6 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Change in Crohn's disease medication ###### Reason **Group ID:** FG000 **Number of Subjects:** 4 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 6 ###### Reason **Group ID:** FG001 **Number of Subjects:** 6 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 4 ###### Reason **Group ID:** FG001 **Number of Subjects:** 3 ##### Withdraw **Type:** Difficulty following the diet ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Physician Decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 99 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 92 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 81 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 77 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 18 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 15 #### Period **Title:** Week 6 to Week 12 ##### Withdraw **Type:** Change in medication ###### Reason **Group ID:** FG000 **Number of Subjects:** 5 ###### Reason **Group ID:** FG001 **Number of Subjects:** 7 ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 4 ###### Reason **Group ID:** FG001 **Number of Subjects:** 3 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 9 ###### Reason **Group ID:** FG001 **Number of Subjects:** 4 ##### Withdraw **Type:** Difficulty following the assigned diet ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 3 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 81 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 77 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 61 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 60 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 20 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 17 **Pre-Assignment Details:** There were 3 main reasons that participants who consented to the study were not randomized. The majority did not meet eligibility criteria. A small number withdrew or were lost to follow-up **Recruitment Details:** The study was conducted in 33 clinical sites across the United States. Enrollment in the trial occurred between September 29, 2017 and October 8, 2019. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT03791879 **Brief Title:** Caudal Dexmedetomidine Analgesia in Pediatrics . **Official Title:** The Analgesic Effectiveness and Safety of Upgraded Caudal Dexmedetomidine Doses in Pediatric Hypospadias Surgery. #### Organization Study ID Info **ID:** MFM IR.18.11.322 - 2018/11/11 #### Organization **Class:** OTHER **Full Name:** Mansoura University ### Status Module #### Completion Date **Date:** 2020-10-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-03-01 **Type:** ACTUAL **Last Update Submit Date:** 2021-02-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-10-01 **Type:** ACTUAL #### Start Date **Date:** 2019-01-01 **Type:** ACTUAL **Status Verified Date:** 2021-02 #### Study First Post Date **Date:** 2019-01-03 **Type:** ACTUAL **Study First Submit Date:** 2018-12-29 **Study First Submit QC Date:** 2018-12-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Investigator Affiliation:** Mansoura University **Investigator Full Name:** Mohamed Abd Latif Ghanim **Investigator Title:** Associate Professor os anesthesia ICU & Pain medicine. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective concentration) in providing pain relief over a 24-h period and lowest surgical stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of dexamedatomedine \>1 µg/kg could not add more analgesic \& stress response obtundation outcome, but increase side effects (sedation and hemodynamic depression). The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least side effects\& stress response modulation, guided by PO Cortisol peak difference in between the study groups during pediatric hypospadias surgery. **Detailed Description:** Background: Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective concentration) in providing pain relief over a 24-h period and lowest surgical stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of dexamedatomedine \>1 µg/kg could not add more analgesic \& stress response obtundation outcome, but increase side effects (sedation and hemodynamic depression).The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least side effects\& stress response modulation, guided by PO Cortisol peak difference in between the study groups during pediatric hypospadias surgery. Optimal effective dose defined as; the least caudal DEXM dose which produce the best analgesic outcome \[least time to 1st analgesic request and lowest rescue analgesic dose (24Hs)\] associated with the least stress response (cortisol PO. first One hour peak), least PO sedation, and hemodynamic stability IO. \&PO. HR \& MAP. The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. . Material \& Methods A prospective randomized double blinded (drug injector and PO assessor) comparative study will be conducted in Mansoura university hospital after obtaining ethics committee approval and written informed parental consent 164 boys (age 1-6 years, ASA I) scheduled for hypospadias surgery. Exclusion criteria; (Operative time exceeding 3 hours, bodyweight \>25kg, bleeding diathesis, infection at the site of block, pre-existing neurological or spinal disease or abnormalities of the sacrum, inability to palpate the sacral hiatus by anatomic landmark palpation technique) or those with a history of allergic reactions to local anesthetics were excluded from the study. Patients will fast for solids 6h and water and 2 hours before surgery. After Patient Preoperative preparation, General anesthesia induction, caudal block and caudal drug injection (Levob plus DEXM) bolus will be injected according to each group as follow; * Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/kg. * Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg. * Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/kg. * Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg. The study outcomes recording: 1ry outcome: Time to (1st analgesic request OPS \>4). Secondary outcome: Total 24hours PO. Rescue analgesic dose IM pethidine 0.5mg/kg \[2,3\] based on local policy and protocol, Patients demographic data \[age, weight, end tidal Sevoflurane (volume %) prior starting skin closure, intraoperative fentanyl total dose, recovery time (time from discontinuation of anesthesia to spontaneous eye opening)\], Serum Cortisol level at basal before anesthesia and 1hour postoperative in between groups \[1\] , Apnea incidence (NO\&%), and desaturation (NO\&%), Objective pain score, Sedation score, Behavioral score for Agitation assessment, and Modified bromage score (residual Lower limb muscle weakness) recorded every 15 minutes for 1st hour then every 30 minutes for next 3 PO hours then at next 6th, 12th, 18th, 24th PO hours, hemodynamics, HR\&SBP the incidence of bradycardia and hypotension per 50% percentile. Recorded every 10 minutes IO for maximum operative time 3 hours and every 30 min PO for next 2h in the recovery room until the child was discharged to the ward. ### Conditions Module **Conditions:** - 164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal Block **Keywords:** - Caudal - Dexmedetomidine - Levobupivacaine - hypospadias ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 164 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Caudal dexamedatomidine analgesia **Label:** • Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/k **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: Caudal dexamedatomidine analgesia **Label:** • Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg. **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Intervention Names:** - Drug: Caudal dexamedatomidine analgesia **Label:** • Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/ **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Intervention Names:** - Drug: Caudal dexamedatomidine analgesia **Label:** • Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg. **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - • Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/k - • Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg. - • Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/ - • Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg. **Description:** Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22-G short-beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament. After needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg. **Name:** Caudal dexamedatomidine analgesia **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** time from full recovery till child express moderate pain OPS 4 and ask for the first analgesic dose **Measure:** Time to (1st analgesic request objective pain score (OPS) ≥4) **Time Frame:** Basal (0) till 24 hours. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 164 boys (age 1-8 years, ASA I) scheduled for hypospadias surgery Exclusion Criteria: * Operative time exceeding 3 hours, bodyweight \>25kg, bleeding diathesis, infection at the site of block, pre-existing neurological or spinal disease or abnormalities of the sacrum, inability to palpate the sacral hiatus by anatomic landmark palpation technique) or those with a history of allergic reactions to local anesthetics were excluded from the study **Gender Based:** True **Maximum Age:** 8 Years **Minimum Age:** 1 Year **Sex:** MALE **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Mansoura **Country:** Egypt **Facility:** Anesthesia department,Faculty of medicine, Mansoura univerisety #### Overall Officials **Official 1:** **Affiliation:** Mansoura Univeristy **Name:** mohamed A Ghanem, A professor **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014564 - Term: Urogenital Abnormalities - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000010409 - Term: Penile Diseases - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10071 - Name: Hypospadias - Relevance: HIGH - As Found: Hypospadias - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M17314 - Name: Urogenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M13320 - Name: Penile Diseases - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007021 - Term: Hypospadias ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M22662 - Name: Dexmedetomidine - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M1832 - Name: Levobupivacaine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05531279 **Brief Title:** A Study of PEG-rhG-CSF and rhG-CSF Used for Aplastic Anemia Granulocyte Deficiency **Official Title:** A Randomized,Open-label Dose-discovery Study of PEG-rhG-CSF and rhG-CSF in the Adjuvant Therapy of Aplastic Anemia Granulocyte Deficiency #### Organization Study ID Info **ID:** IIT2021022-EC-1 #### Organization **Class:** OTHER **Full Name:** Institute of Hematology & Blood Diseases Hospital, China ### Status Module #### Completion Date **Date:** 2026-01-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-09-26 **Type:** ACTUAL **Last Update Submit Date:** 2022-09-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-05 **Type:** ESTIMATED #### Start Date **Date:** 2022-06-05 **Type:** ACTUAL **Status Verified Date:** 2022-09 #### Study First Post Date **Date:** 2022-09-07 **Type:** ACTUAL **Study First Submit Date:** 2022-09-02 **Study First Submit QC Date:** 2022-09-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Institute of Hematology & Blood Diseases Hospital, China #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia. **Detailed Description:** This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.Research objectives: To explore the reasonable injection frequency of long-acting PEG-rhG-CSF in the adjuvant treatment of aplastic anemia patients with granulocytosis through a single center prospective clinical study.Disease classification of aplastic anemia: a total of 45 cases of SAA/VSAA with ANC\<0.5×109/L were stratified and randomized into three groups according to the radio of 1:1:1(15 cases in each group).PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected;PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected;RhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.Dose/protocol adjustment: after monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the original group of drugs. ### Conditions Module **Conditions:** - Severe Aplastic Anemia **Keywords:** - G-CSF ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected,after monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the same drug. **Intervention Names:** - Drug: PEG-rhG-CSF **Label:** PEG-rhG-CSF group A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected,after monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the same drug. **Intervention Names:** - Drug: PEG-rhG-CSF **Label:** PEG-rhG-CSF group B **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** rhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.After monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the same drug. **Intervention Names:** - Drug: PEG-rhG-CSF **Label:** rhG-CSF group(short-acting ) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - PEG-rhG-CSF group A - PEG-rhG-CSF group B - rhG-CSF group(short-acting ) **Description:** PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected; PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected; RhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected. **Name:** PEG-rhG-CSF **Other Names:** - rhG-CSF **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** total number of effective (ANC\>0.5×109/L) days during 2 weeks of treatment(cases×days). **Measure:** total number of effective (ANC>0.5×109/L) days **Time Frame:** 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18-70 years old, male or female, or weight≥50kg. 2. Patients with severe or very severe aplastic anemia of absolute neutrophil value\< 0.5×109/L 3. ECOG score ≤ 2 points. 4. Normal renal function. Exclusion Criteria: 1. Patients with clonal chromosomal abnormalities. 2. Patients with previous malignant tumors. 3. Patients with severe or uncontrolled infectious diseases and /or bleeding. 4. Patients with AIDS or syphilis positive. 5. Severe organ dysfunction. 6. Patients used GM/G-CSF,PEG-rhG-CSF,interleukin-11 within 2 weeks before admission. 7. Allergic to G-CSF or PEG-rhG-CSF related components. 8. Participated in other clinical trials within 6 months. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Fengkui Zhang, Doctor **Phone:** +862223909229 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Huihui Fan, Doctor **Phone:** +862223909223 **Role:** CONTACT #### Locations **Location 1:** **City:** Tianjin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Fengkui Zhang, Doctor - **Phone:** 8602223909229 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Huihui Fan, Doctor - **Phone:** 8602223909223 - **Role:** CONTACT **Country:** China **Facility:** Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences **State:** Tianjin **Status:** RECRUITING **Zip:** 300020 #### Overall Officials **Official 1:** **Affiliation:** Institute of Hematology ＆ Blood Diseases Hospital，Chinese Academy of Medical Sciences **Name:** Liping Jing, Doctor **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** After the paper is written and published **Description:** We can share the plan after completing the experiment **Info Types:** - STUDY_PROTOCOL - ICF - CSR **IPD Sharing:** YES **Time Frame:** Follow-up and publication of the paper are planned for December 2025 ### References Module #### References **Citation:** Tichelli A, Schrezenmeier H, Socie G, Marsh J, Bacigalupo A, Duhrsen U, Franzke A, Hallek M, Thiel E, Wilhelm M, Hochsmann B, Barrois A, Champion K, Passweg JR. A randomized controlled study in patients with newly diagnosed severe aplastic anemia receiving antithymocyte globulin (ATG), cyclosporine, with or without G-CSF: a study of the SAA Working Party of the European Group for Blood and Marrow Transplantation. Blood. 2011 Apr 28;117(17):4434-41. doi: 10.1182/blood-2010-08-304071. Epub 2011 Jan 13. **PMID:** 21233311 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006402 - Term: Hematologic Diseases - ID: D000080983 - Term: Bone Marrow Failure Disorders - ID: D000001855 - Term: Bone Marrow Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4071 - Name: Anemia, Aplastic - Relevance: HIGH - As Found: Aplastic Anemia - ID: M4070 - Name: Anemia - Relevance: HIGH - As Found: Anemia - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2241 - Name: Bone Marrow Failure Disorders - Relevance: LOW - As Found: Unknown - ID: M13118 - Name: Pancytopenia - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: T460 - Name: Aplastic Anemia - Relevance: HIGH - As Found: Aplastic Anemia ### Condition Browse Module - Meshes - ID: D000000740 - Term: Anemia - ID: D000000741 - Term: Anemia, Aplastic ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M271049 - Name: Coenzyme Q10 - Relevance: LOW - As Found: Unknown - ID: M17201 - Name: Ubiquinone - Relevance: LOW - As Found: Unknown - ID: T383 - Name: Coenzyme Q10 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00684879 **Brief Title:** Screening Behavior in Adults With Hereditary Hemorrhagic Telangiectasia **Official Title:** Illness Perceptions and the Health Belief Model: Screening Behavior in Adults With Hereditary Hemorrhagic Telangiectasia #### Organization Study ID Info **ID:** 999908143 #### Organization **Class:** NIH **Full Name:** National Institutes of Health Clinical Center (CC) #### Secondary ID Infos **ID:** 08-HG-N143 ### Status Module #### Completion Date **Date:** 2016-01-07 #### Expanded Access Info #### Last Update Post Date **Date:** 2019-11-25 **Type:** ACTUAL **Last Update Submit Date:** 2019-11-22 **Overall Status:** COMPLETED #### Start Date **Date:** 2008-05-21 **Status Verified Date:** 2016-01-07 #### Study First Post Date **Date:** 2008-05-28 **Type:** ESTIMATED **Study First Submit Date:** 2008-05-24 **Study First Submit QC Date:** 2008-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Human Genome Research Institute (NHGRI) #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** This study will explore the factors that influence screening behaviors of adults diagnosed with hereditary hemorrhagic telangiectasia (HHT), an inherited condition in which blood vessel defects called arteriovenous malformations (AVMs) result in direct connections between arteries and veins. Patients most commonly have small AVMs called telangiectases on the tongue, face, hands, mouth, and throat and the mucosal linings of the nose and gastrointestinal tract. Recurrent nosebleeds are a hallmark of the disease. Large AVMs can also occur in various organs, causing sudden and life-threatening complications. The study will examine how patients think and feel about their condition and what actions they take to screen for internal symptoms of the disease. Men and women 18 years of age and older who have HHT may be eligible for this study. Participants fill out a 30-minute questionnaire, available in print or online, that includes questions about the participant s * beliefs about HHT * actions taken to screen for internal symptoms of HHT * experience with HHT * current health status, family history and demographic information **Detailed Description:** The proposed study aims to understand the factors that influence screening behaviors of adults with hereditary hemorrhagic telangiectasia (HHT). HHT is a chronic condition, but with early diagnosis followed by adherence to recommended screening guidelines, the major complications of this disorder can be avoided and disability or even death can be prevented. Yet, it has come to the attention of healthcare professionals that the recommended screening is not commonly followed by individuals with HHT, even when the risk of serious complications is known. Nonadherence to screening recommendations is not unique to HHT. It is rather common across chronic conditions, and genetic diseases, such as HHT, are no exception. However, HHT may have an added barrier to screening and treatment adherence in that it is a rare and underdiagnosed condition. Inadequate knowledge of healthcare providers may be a serious barrier to prevention, diagnosis, and treatment. The Health Belief Model (HBM) can be used to frame this study of HHT screening. The HBM posits that preventive health behaviors will be acted upon if individuals regard themselves as susceptible to the threat, they believe the consequences to be severe, and the perceived benefits outweigh the perceived barriers. In addition to the HBM constructs, this study will also consider the role of illness representations which provide a more personal view of the lived experience of individuals with HHT. A cosss-sectional design will be used to investigate the relationships among the domains of illness representations, HBM constructs (perceived susceptibility, perceived benefits, barriers, self-efficacy, response efficacy, cues to action), and HHT-specific screening guidelines. Participants will be recruited from the HHT Foundation International, Inc., an outline HHT Awareness social group, and HHT Clinics. Participants will be asked to complete either a web-based or a paper survey. The main outcome measure is screening behaviors and intentions to screen for complications associated with HHT. ### Conditions Module **Conditions:** - Osler-Rendu-Weber Disease - Osler-Rendu Disease - Telangiectasia, Hereditary Hemorrhagic **Keywords:** - Hereditary Hemorrhagic Telangiectasia - Health Belief Model - Illness Perceptions - Screening - HHT ### Design Module #### Design Info **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 320 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Eligibility Module **Eligibility Criteria:** * INCLUSION CRITERIA: Men and women who self-report having a diagnosis of HHT. To read and write English. EXCLUSION CRITERIA: Individuals younger than 18. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bethesda **Country:** United States **Facility:** National Human Genome Research Institute (NHGRI), 9000 Rockville Pike **State:** Maryland **Zip:** 20892 #### Overall Officials **Official 1:** **Affiliation:** National Human Genome Research Institute (NHGRI) **Name:** Barbara B Biesecker **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Bayrak-Toydemir P, Mao R, Lewin S, McDonald J. Hereditary hemorrhagic telangiectasia: an overview of diagnosis and management in the molecular era for clinicians. Genet Med. 2004 Jul-Aug;6(4):175-91. doi: 10.1097/01.gim.0000132689.25644.7c. **PMID:** 15266205 **Citation:** Guttmacher AE, Marchuk DA, White RI Jr. Hereditary hemorrhagic telangiectasia. N Engl J Med. 1995 Oct 5;333(14):918-24. doi: 10.1056/NEJM199510053331407. No abstract available. **PMID:** 7666879 **Citation:** Rand CS. Measuring adherence with therapy for chronic diseases: implications for the treatment of heterozygous familial hypercholesterolemia. Am J Cardiol. 1993 Sep 30;72(10):68D-74D. doi: 10.1016/0002-9149(93)90014-4. **PMID:** 8213501 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000020141 - Term: Hemostatic Disorders - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000054079 - Term: Vascular Malformations - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16456 - Name: Telangiectasis - Relevance: HIGH - As Found: Telangiectasia - ID: M16455 - Name: Telangiectasia, Hereditary Hemorrhagic - Relevance: HIGH - As Found: Telangiectasia, Hereditary Hemorrhagic - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M27558 - Name: Vascular Malformations - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - Relevance: LOW - As Found: Unknown - ID: T2750 - Name: Hereditary Hemorrhagic Telangiectasia - Relevance: HIGH - As Found: Hereditary Hemorrhagic Telangiectasia ### Condition Browse Module - Meshes - ID: D000013684 - Term: Telangiectasis - ID: D000013683 - Term: Telangiectasia, Hereditary Hemorrhagic ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02385279 **Acronym:** DESSOLVE III **Brief Title:** Study Comparing the MiStent SES Versus the XIENCE EES Stent **Official Title:** Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MiStent SES) for Revascularization of Coronary Arteries #### Organization Study ID Info **ID:** ECRI-005 #### Organization **Class:** INDUSTRY **Full Name:** ECRI bv ### Status Module #### Completion Date **Date:** 2021-02-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-05-08 **Type:** ACTUAL **Last Update Submit Date:** 2022-07-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-01-31 **Type:** ACTUAL #### Results First Post Date **Date:** 2023-05-08 **Type:** ACTUAL **Results First Submit Date:** 2021-12-08 **Results First Submit QC Date:** 2022-07-12 #### Start Date **Date:** 2015-03-20 **Type:** ACTUAL **Status Verified Date:** 2022-07 #### Study First Post Date **Date:** 2015-03-11 **Type:** ESTIMATED **Study First Submit Date:** 2015-02-17 **Study First Submit QC Date:** 2015-03-05 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Micell Technologies **Class:** INDUSTRY **Name:** Stentys #### Lead Sponsor **Class:** INDUSTRY **Name:** ECRI bv #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events. ### Conditions Module **Conditions:** - Coronary Stenosis **Keywords:** - CAD - ACS - All comers - PCI ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 1398 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. **Intervention Names:** - Device: MiStent **Label:** MiStent® **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. **Intervention Names:** - Device: XIENCE EES **Label:** XIENCE EES **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - MiStent® **Description:** Percutaneous Coronary Intervention **Name:** MiStent **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - XIENCE EES **Description:** Percutaneous Coronary Intervention **Name:** XIENCE EES **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization. **Measure:** Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE) **Time Frame:** 12 months postprocedure #### Secondary Outcomes **Description:** POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization **Measure:** POCE **Time Frame:** At 12 months **Description:** MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR) **Measure:** MACE **Time Frame:** At 12 months **Description:** Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR **Measure:** Target Vessel Failure (TVF) **Time Frame:** At 12 months **Description:** All-cause death **Measure:** All-cause Death **Time Frame:** At 12 months **Description:** Any Myocardial infarction **Measure:** Myocardial Infarction **Time Frame:** At 12 months **Description:** Any revascularization **Measure:** Any Revascularization **Time Frame:** At 12 months **Description:** Definite or probably stent thrombosis according to ARC **Measure:** Stent Thrombosis **Time Frame:** At 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: All comers" patients: * Male or female patients 18 years or older; * Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. * The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria. * The patient is judged to be capable of providing voluntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site. Exclusion Criteria: * Known pregnancy or breastfeeding at time of randomization; * Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor; * Concurrent medical condition with a life expectancy of less than 12 months. * The patient is unwilling/ not able to return for outpatient clinic at 1 month and 12 months follow-up. * Currently participating in another trial and not yet at its primary endpoint. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Corbeil **Country:** France **Facility:** Research Center Corbeil **Location 2:** **City:** Nimes **Country:** France **Facility:** Research Center Nimes **Location 3:** **City:** Poitiers **Country:** France **Facility:** Research Center Poitiers **Location 4:** **City:** Jena **Country:** Germany **Facility:** Research Center Jena **Location 5:** **City:** Leipzig **Country:** Germany **Facility:** Research Center Leipzig **Location 6:** **City:** Munster **Country:** Germany **Facility:** Research Center Munster **Location 7:** **City:** Ulm **Country:** Germany **Facility:** Research Center Ulm **Location 8:** **City:** Wiesbaden **Country:** Germany **Facility:** Research Center Wiesbaden **Location 9:** **City:** Amersfoort **Country:** Netherlands **Facility:** Research Center Amersfoort **Location 10:** **City:** Amsterdam **Country:** Netherlands **Facility:** Research Center Amsterdam **Location 11:** **City:** Blaricum **Country:** Netherlands **Facility:** Tergooi **Location 12:** **City:** Emmen **Country:** Netherlands **Facility:** Research Center Emmen **Location 13:** **City:** Leeuwarden **Country:** Netherlands **Facility:** Research Center Leeuwarden **Location 14:** **City:** Nijmegen **Country:** Netherlands **Facility:** Research Center Nijmegen **Location 15:** **City:** Venlo **Country:** Netherlands **Facility:** Research Center Venlo **Location 16:** **City:** Belchatow **Country:** Poland **Facility:** Research Center Belchatow **Location 17:** **City:** Bielsko-Biala **Country:** Poland **Facility:** Research Center Bielsko-Biala **Location 18:** **City:** Chrzanow **Country:** Poland **Facility:** Research center Chrzanow **Location 19:** **City:** Tychy **Country:** Poland **Facility:** Research Center Tychy **Location 20:** **City:** Zgierz **Country:** Poland **Facility:** Research Center Zgierz #### Overall Officials **Official 1:** **Affiliation:** European Cardiovascular Research Institute **Name:** Ernest Spitzer, MD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** de Winter RJ, Katagiri Y, Asano T, Milewski KP, Lurz P, Buszman P, Jessurun GAJ, Koch KT, Troquay RPT, Hamer BJB, Ophuis TO, Wohrle J, Wyderka R, Cayla G, Hofma SH, Levesque S, Zurakowski A, Fischer D, Kosmider M, Goube P, Arkenbout EK, Noutsias M, Ferrari MW, Onuma Y, Wijns W, Serruys PW. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial. Lancet. 2018 Feb 3;391(10119):431-440. doi: 10.1016/S0140-6736(17)33103-3. Epub 2017 Dec 5. **PMID:** 29203070 **Citation:** Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008055. doi: 10.1161/CIRCOUTCOMES.121.008055. Epub 2021 Oct 20. **PMID:** 34666500 **Citation:** Katagiri Y, Andreini D, Miyazaki Y, Takahashi K, Komiyama H, Mushtaq S, Sonck J, Schoors D, Maisano F, Kaufman PA, Leal I, Lindeboom W, Piek JJ, Wykrzykowska JJ, Morel MA, Bartorelli AL, Onuma Y, Serruys PW; SYNTAX III REVOLUTION Investigators. Site vs. core laboratory variability in computed tomographic angiography-derived SYNTAX scores in the SYNTAX III trial. Eur Heart J Cardiovasc Imaging. 2021 Aug 14;22(9):1063-1071. doi: 10.1093/ehjci/jeaa172. **PMID:** 32888011 **Citation:** Takahashi K, Serruys PW, Kogame N, Buszman P, Lurz P, Jessurun GAJ, Koch KT, Troquay RPT, Hamer BJB, Oude Ophuis T, Milewski KP, Hofma SH, Wykrzykowska JJ, Onuma Y, de Winter RJ, Wijns W. Final 3-Year Outcomes of MiStent Biodegradable Polymer Crystalline Sirolimus-Eluting Stent Versus Xience Permanent Polymer Everolimus-Eluting Stent: Insights From the DESSOLVE III All-Comers Randomized Trial. Circ Cardiovasc Interv. 2020 Jun;13(6):e008737. doi: 10.1161/CIRCINTERVENTIONS.119.008737. Epub 2020 May 29. **PMID:** 32466676 ## Document Section ### Large Document Module #### Large Docs - Date: 2018-03-07 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 568483 - Type Abbrev: Prot_SAP - Upload Date: 2021-12-08T05:05 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003327 - Term: Coronary Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown - ID: M22913 - Name: Coronary Stenosis - Relevance: HIGH - As Found: Coronary Stenosis - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000023921 - Term: Coronary Stenosis ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M255 - Name: Everolimus - Relevance: LOW - As Found: Unknown - ID: M21960 - Name: Sirolimus - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** Adverse event reporting in the context of a post-marketing trial. #### Event Groups **Group ID:** EG000 **Title:** MiStent® **Deaths Num Affected:** 85 **Deaths Num At Risk:** 703 **Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention **ID:** EG000 **Other Num Affected:** 76 **Other Num at Risk:** 703 **Serious Number Affected:** 434 **Serious Number At Risk:** 703 **Title:** MiStent® **Group ID:** EG001 **Title:** XIENCE EES **Deaths Num Affected:** 78 **Deaths Num At Risk:** 695 **Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention **ID:** EG001 **Other Num Affected:** 71 **Other Num at Risk:** 695 **Serious Number Affected:** 426 **Serious Number At Risk:** 695 **Title:** XIENCE EES **Frequency Threshold:** 0 #### Other Events **Term:** Non Serious AE **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MEDDEV 2.7/3 #### Serious Events **Term:** Myocardial infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MEDDEV 2.7/3 ##### Stats **Group ID:** EG000 **Num Affected:** 17 **Num At Risk:** 703 **Group ID:** EG001 **Num Affected:** 15 **Num At Risk:** 695 **Term:** Definite stent thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MEDDEV 2.7/3 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 703 **Group ID:** EG001 **Num Affected:** 5 **Num At Risk:** 695 **Term:** Other **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MEDDEV 2.7/3 ##### Stats **Group ID:** EG000 **Num Affected:** 414 **Num At Risk:** 703 **Group ID:** EG001 **Num Affected:** 406 **Num At Risk:** 695 **Time Frame:** 12 months (primary reporting), and yearly up to 5 years. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 703 **Group ID:** BG001 **Value:** 695 **Group ID:** BG002 **Value:** 1398 **Units:** Participants ### Group **ID:** BG000 **Title:** MiStent® **Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention ### Group **ID:** BG001 **Title:** XIENCE EES **Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 257 #### Measurement **Group ID:** BG001 **Value:** 271 #### Measurement **Group ID:** BG002 **Value:** 528 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 446 #### Measurement **Group ID:** BG001 **Value:** 424 #### Measurement **Group ID:** BG002 **Value:** 870 **Category Title:** >=65 years #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 703 **Group ID:** BG001 **Value:** 695 **Group ID:** BG002 **Value:** 1398 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 10.7 **Value:** 66.4 #### Measurement **Group ID:** BG001 **Spread:** 10.7 **Value:** 66.3 #### Measurement **Group ID:** BG002 **Spread:** 10.7 **Value:** 66.4 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 703 **Group ID:** BG001 **Value:** 695 **Group ID:** BG002 **Value:** 1398 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 209 #### Measurement **Group ID:** BG001 **Value:** 182 #### Measurement **Group ID:** BG002 **Value:** 391 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 494 #### Measurement **Group ID:** BG001 **Value:** 513 #### Measurement **Group ID:** BG002 **Value:** 1007 **Category Title:** Male #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 703 **Group ID:** BG001 **Value:** 695 **Group ID:** BG002 **Value:** 1398 **Class Title:** ### Measure #### Measurement **Group ID:** BG002 **Value:** 0 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 0 **Group ID:** BG001 **Value:** 0 **Group ID:** BG002 **Value:** 0 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 297 #### Measurement **Group ID:** BG001 **Value:** 296 #### Measurement **Group ID:** BG002 **Value:** 593 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 703 **Group ID:** BG001 **Value:** 695 **Group ID:** BG002 **Value:** 1398 **Class Title:** Netherlands #### Measurement **Group ID:** BG000 **Value:** 187 #### Measurement **Group ID:** BG001 **Value:** 184 #### Measurement **Group ID:** BG002 **Value:** 371 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 703 **Group ID:** BG001 **Value:** 695 **Group ID:** BG002 **Value:** 1398 **Class Title:** Poland #### Measurement **Group ID:** BG000 **Value:** 56 #### Measurement **Group ID:** BG001 **Value:** 56 #### Measurement **Group ID:** BG002 **Value:** 112 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 703 **Group ID:** BG001 **Value:** 695 **Group ID:** BG002 **Value:** 1398 **Class Title:** France #### Measurement **Group ID:** BG000 **Value:** 163 #### Measurement **Group ID:** BG001 **Value:** 159 #### Measurement **Group ID:** BG002 **Value:** 322 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 703 **Group ID:** BG001 **Value:** 695 **Group ID:** BG002 **Value:** 1398 **Class Title:** Germany **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Race and Ethnicity were not collected from any participant. **Title:** Race and Ethnicity Not Collected **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **Restrictive Agreement:** True ### Point of Contact **Email:** [email protected] **Organization:** European Cardiovascular Research Institute **Phone:** +31102062828 **Title:** Dr. E. Spitzer ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 40 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 45 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 93 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 101 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 65 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 65 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 45 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 53 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 25 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 18 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 17 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 15 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 61 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 78 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Intention-to-treat **Reporting Status:** POSTED **Time Frame:** 12 months postprocedure **Title:** Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE) **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention **ID:** OG000 **Title:** MiStent® ##### Group **Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention **ID:** OG001 **Title:** XIENCE EES #### Outcome Measure 2 **Description:** POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** ITT **Reporting Status:** POSTED **Time Frame:** At 12 months **Title:** POCE **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention **ID:** OG000 **Title:** MiStent® ##### Group **Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention **ID:** OG001 **Title:** XIENCE EES #### Outcome Measure 3 **Description:** MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR) **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** At 12 months **Title:** MACE **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention **ID:** OG000 **Title:** MiStent® ##### Group **Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention **ID:** OG001 **Title:** XIENCE EES #### Outcome Measure 4 **Description:** Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** ITT **Reporting Status:** POSTED **Time Frame:** At 12 months **Title:** Target Vessel Failure (TVF) **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention **ID:** OG000 **Title:** MiStent® ##### Group **Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention **ID:** OG001 **Title:** XIENCE EES #### Outcome Measure 5 **Description:** All-cause death **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** ITT **Reporting Status:** POSTED **Time Frame:** At 12 months **Title:** All-cause Death **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention **ID:** OG000 **Title:** MiStent® ##### Group **Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention **ID:** OG001 **Title:** XIENCE EES #### Outcome Measure 6 **Description:** Any Myocardial infarction **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** At 12 months **Title:** Myocardial Infarction **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention **ID:** OG000 **Title:** MiStent® ##### Group **Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention **ID:** OG001 **Title:** XIENCE EES #### Outcome Measure 7 **Description:** Any revascularization **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** At 12 months **Title:** Any Revascularization **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention **ID:** OG000 **Title:** MiStent® ##### Group **Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention **ID:** OG001 **Title:** XIENCE EES #### Outcome Measure 8 **Description:** Definite or probably stent thrombosis according to ARC **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** At 12 months **Title:** Stent Thrombosis **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention **ID:** OG000 **Title:** MiStent® ##### Group **Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention **ID:** OG001 **Title:** XIENCE EES ### Participant Flow Module #### Group **Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention **ID:** FG000 **Title:** MiStent® #### Group **Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention **ID:** FG001 **Title:** XIENCE EES #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 703 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 695 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 676 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 677 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 27 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 18 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04128579 **Acronym:** EQUALISE **Brief Title:** Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis **Official Title:** A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis #### Organization Study ID Info **ID:** EQ001-19-002 #### Organization **Class:** INDUSTRY **Full Name:** Equillium ### Status Module #### Completion Date **Date:** 2024-01-18 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-16 **Type:** ACTUAL #### Start Date **Date:** 2019-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2019-10-16 **Type:** ACTUAL **Study First Submit Date:** 2019-09-30 **Study First Submit QC Date:** 2019-10-14 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Biocon Limited #### Lead Sponsor **Class:** INDUSTRY **Name:** Equillium #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis **Detailed Description:** The study will enroll approximately 55 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for Type A-SLE and a single dose cohort of approximately 20 open-label subjects enrolled for Type B-Lupus Nephritis. Subjects will receive itolizumab administered subcutaneously every two weeks for a total of either 2 (Type A) or 13 (Type B) doses with 4 or 12 weeks of follow-up after the last dose of investigational product. ### Conditions Module **Conditions:** - Lupus Erythematosus - Lupus Nephritis **Keywords:** - Systemic Lupus Erythematosus - Active Proliferative Lupus Nephritis ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** cohort based escalation of 6 subjects (Type A) single dose cohort of 20 subjects (Type B) ##### Masking Info **Masking:** NONE **Masking Description:** Type A and Type B are open-label. **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 55 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses (up to 5 cohorts with dosing to be determined in the range of 0.4 -- 3.2 mg/kg). **Intervention Names:** - Drug: Itolizumab [Bmab 600] **Label:** EQ001 Type A cohort **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg). **Intervention Names:** - Drug: Itolizumab [Bmab 600] **Label:** EQ001 for Type B cohort **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - EQ001 Type A cohort - EQ001 for Type B cohort **Description:** EQ001 **Name:** Itolizumab [Bmab 600] **Other Names:** - Bmab600 - Itolizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. **Measure:** Incidence of Treatment Emergent Adverse Events **Time Frame:** Type A up to Day 57 or Type B up to Day 253 #### Secondary Outcomes **Description:** To characterize the pharmacokinetics of itolizumab **Measure:** To characterize the PK of itolizumab **Time Frame:** Type A up to Day 57 or Type B up to Day 253 **Description:** the % levels of free versus EQ001-bound CD6 receptor on T cells **Measure:** CD6 receptor occupancy **Time Frame:** Type A up to Day 57 or Type B up to Day 253 ### Eligibility Module **Eligibility Criteria:** Type A Cohort Key Inclusion Criteria: 1. Is male or female, age ≥ 18 and ≤ 75 years 2. Has previously been documented to have met or currently meets Systemic Lupus International Collaborating Clinics (SLICC) and/or American College of Rheumatology (ACR) criteria for SLE 3. Received at least 1 immunosuppressive or immunomodulatory treatment for SLE at any time in the past or currently 4. Has documented elevation of antinuclear antibodies (ANA) in the past or during Screening 5. Restricted SLE treatments are stable and/or washed out 6. During Screening, has adequate hematologic function Type B Cohort Key Inclusion Criteria: 1. Is male or female, age ≥ 18 and ≤ 75 years 2. Has a diagnosis of SLE 3. Kidney biopsy with a histologic diagnosis of LN Classes III or IV (+/- V) 4. Has a urine protein to creatinine ratio of \> 1000 mg/g 5. Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease or has an incomplete response to current treatment 6. Has adequate hematologic function 7. Restricted SLE treatments are stable and/or washed out 8. Most recent eGFR ≥ 40 mL/min/1.73m2 9. Has evidence of serologic activity Key Exclusion Criteria: 1. Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy 2. Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV 3. Active TB or a positive TB test **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Sun City **Country:** United States **Facility:** AKDHC Medical Research Services, LLC **State:** Arizona **Zip:** 85351 **Location 2:** **City:** Chula Vista **Country:** United States **Facility:** California Institute of Renal Research **State:** California **Zip:** 91910 **Location 3:** **City:** La Jolla **Country:** United States **Facility:** University of California San Diego Perlman Ambulatory Clinic **State:** California **Zip:** 92037 **Location 4:** **City:** Clearwater **Country:** United States **Facility:** Clinical Research of West Florida - Clearwater **State:** Florida **Zip:** 33765-2616 **Location 5:** **City:** Fort Lauderdale **Country:** United States **Facility:** Centre for Rheumatology, Immunology and Arthritis **State:** Florida **Zip:** 33309 **Location 6:** **City:** Gainesville **Country:** United States **Facility:** University of Florida, Division of Rheumatology **State:** Florida **Zip:** 32610 **Location 7:** **City:** Leesburg **Country:** United States **Facility:** Clinical Site Partners Leesburg, LLC **State:** Florida **Zip:** 34748 **Location 8:** **City:** Miami **Country:** United States **Facility:** SouthCoast Research Center Inc **State:** Florida **Zip:** 33136 **Location 9:** **City:** Miami **Country:** United States **Facility:** Hope Clinical Trials **State:** Florida **Zip:** 33165 **Location 10:** **City:** Orlando **Country:** United States **Facility:** Omega Research Maitland, LLC **State:** Florida **Zip:** 32810 **Location 11:** **City:** Tampa **Country:** United States **Facility:** Clinical Research of West Florida - Tampa **State:** Florida **Zip:** 33603 **Location 12:** **City:** Tampa **Country:** United States **Facility:** University of South Florida **State:** Florida **Zip:** 33606 **Location 13:** **City:** Lawrenceville **Country:** United States **Facility:** Georgia Nephrology **State:** Georgia **Zip:** 30046 **Location 14:** **City:** Bronx **Country:** United States **Facility:** Albert Einstein College of Medicine, Montefiore Medical Center **State:** New York **Zip:** 10461 **Location 15:** **City:** Great Neck **Country:** United States **Facility:** Northwell Health / Division of Rheumatology **State:** New York **Zip:** 11021 **Location 16:** **City:** New York **Country:** United States **Facility:** Columbia University Medical Center, Div of Nephrology **State:** New York **Zip:** 10032 **Location 17:** **City:** Bethlehem **Country:** United States **Facility:** Northeast Clinical Research Center, LLC **State:** Pennsylvania **Zip:** 18017 **Location 18:** **City:** Dallas **Country:** United States **Facility:** Dallas Renal Group **State:** Texas **Zip:** 75230 **Location 19:** **City:** Houston **Country:** United States **Facility:** Prolato Clinical Research Center (PCRC) **State:** Texas **Zip:** 77054 **Location 20:** **City:** Chandigarh **Country:** India **Facility:** Post Graduate Institute of Medical Education and Research (PGIMER) **Location 21:** **City:** Gurugramam **Country:** India **Facility:** Medanta - The Medicity Hospital **Location 22:** **City:** New Delhi **Country:** India **Facility:** MAX Super Specialty Hospital **Location 23:** **City:** Puducherry **Country:** India **Facility:** Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER) **Location 24:** **City:** Warszawa **Country:** Poland **Facility:** Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ **Zip:** 04-749 **Location 25:** **City:** Łódź **Country:** Poland **Facility:** SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii **Zip:** 92-213 #### Overall Officials **Official 1:** **Affiliation:** UCSD **Name:** Kenneth Kalunian, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** company website **URL:** https://equilliumbio.com/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000005921 - Term: Glomerulonephritis ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12338 - Name: Nephritis - Relevance: HIGH - As Found: Nephritis - ID: M11178 - Name: Lupus Nephritis - Relevance: HIGH - As Found: Lupus Nephritis - ID: M11177 - Name: Lupus Erythematosus, Systemic - Relevance: HIGH - As Found: Systemic Lupus Erythematosus - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M9031 - Name: Glomerulonephritis - Relevance: LOW - As Found: Unknown - ID: T3523 - Name: Lupus Nephritis - Relevance: HIGH - As Found: Lupus Nephritis - ID: T2525 - Name: Glomerulonephritis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009393 - Term: Nephritis - ID: D000008181 - Term: Lupus Nephritis - ID: D000008180 - Term: Lupus Erythematosus, Systemic ### Misc Info Module - Version Holder: 2024-05-24