Расширенное исследование перорального восприятия озанимода при умеренной и активной болезни Крона
Название протокола
Клинические исследование Болезнь Крона: Озанимод - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры
Ведущий спонсор:
Celgene
Источник
Celgene
Краткое содержание
Это дополнительное исследование для оценки безопасности и эффективности озанимода у участников с Болезнь Крона средней и английской степени.
Общий статус
Рекрутинг
Дата начала
2018-08-22
Дата завершения
2026-09-24
Дата первичного завершения
2026-06-26
Фаза
Фаза 3
Тип исследования
Интервенционный
Первичный результат
Мера
Временное ограничение
Доля участников с оценкой CDAI < 150
до 234 недель
Вторичный результат
Мера
Временное ограничение
Proportion of participants with a simple endoscopy score (SES-CD) decrease from baseline of ≥ 50%
Up to 234 Weeks
Доля участников со средней дневной оценкой боли в животе ≤ 1 балла и средней дневной частотой стула ≤ 3 баллов с болью в животе и частотой стула не хуже исходного уровня
до 234 недель
Доля участников со снижением CDAI по сравнению с исходным уровнем на ≥ 100 баллов или показателем CDAI < 150
до 234 недель
Доля участников с отсутствием язв ≥ 0,5 см без сегментов с какой-либо изъязвленной поверхностью ≥ 10%
до 234 недель
Доля участников со снижением CDAI по сравнению с исходным уровнем ≥ 70 баллов
до 234 недель
Изменение CDAI по сравнению с исходным уровнем
до 234 недель
Доля участников со снижением CDAI по сравнению с исходным уровнем на ≥ 100 баллов или показателем CDAI < 150 и снижением SES-CD по сравнению с исходным уровнем на ≥ 50%
до 234 недель
Доля участников с оценкой CDAI < 150 и SES-CD ≤ 4 баллов и снижением SES-CD ≥ 2 баллов
до 234 недель
Доля участников со средней дневной оценкой боли в животе ≤ 1 балла и средней дневной частотой стула ≤ 3 баллов с болью в животе и частотой стула не хуже исходного уровня и SES-CD ≤ 4 балла и снижением SES-CD ≥ 2 баллов
до 234 недель
Доля участников с SES-CD ≤ 4 баллов и снижением SES-CD ≥ 2 баллов
до 234 недель
Доля участников с показателем CDAI < 150 среди участников, не принимающих кортикостероиды
до 234 недель
Доля участников со снижением эндоскопического индекса тяжести болезни Крона (CDEIS) по сравнению с исходным уровнем на ≥ 50%
до 234 недель
Регистрация
1200
Состояние
Болезнь Крона
Вмешательство
Тип вмешательства:
Препарат, средство, медикамент
Название вмешательства:
Озанимод
Описание:
Указанная доза в области дни
Этикетка Arm Group:
Прием перорального Озанимода
Приемлемость
Критерии:
Для получения дополнительной информации об исторических испытаниях Bristol-Myers Squibb, пожалуйста, Посетите: www.BMSStudyConnect.com Критерии включения: - Нет клинического ответа или клинической ремиссии после завершения 12 недель лечения. Индукционные исследования - Испытайте периодичность или завершите обслуживание - Завершить исследование озанимода при болезни Крона и соответствуют критериям для участие Критерии исключения: - Имеются значимые печеночные, неврологические, легочные, офтальмологические, эндокринное, психиатрическое или другое серьезное системное упражнение, протокол или интерпретация сложных исследований или это поставлено на рассмотрение в риск, участвуя в обнаружении - подозревает или диагностирует интраабдоминальный или перианальный абсцесс, который не лечился предложение - Получает лечение от следующих препаратов или вмешательств в рамках Ингибиторы, индукторы и ингибиторы моноаминоксидазы CYP2C8 При выдвижении других обвинений в протоколе обвинения/исключения.
Пол:
Все
Минимальный возраст:
18 лет
Максимальный возраст:
75 лет
Здоровые волонтеры:
Нет
Общий Официальный
Фамилия
Роль
Присоединение
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Общий контакт
Фамилия:
Recruiting sites have contact information. Please contact the site directly. If there is no contact information,
Телефон:
please email:
Расположение
Объект:
Положение дел:
Holland Center for Family Health
| Peoria, Arizona, 85381, United States
Completed
Elite Clinical Studies, LLC
| Phoenix, Arizona, 85018, United States
Not yet recruiting
HonorHealth Research Institute
| Scottsdale, Arizona, 85258, United States
Not yet recruiting
Arkansas Gastroenterology, P.A.
| North Little Rock, Arkansas, 72117, United States
Recruiting
Sharp Chula Vista Medical Center
| Chula Vista, California, 91911, United States
Recruiting
Kindred Medical Institute for Clinical Trials, LLC
| Corona, California, 92879, United States
Not yet recruiting
Valley View Internal Medicine
| Garden Grove, California, 92843, United States
Recruiting
UCSD Medical Center
| La Jolla, California, 92037, United States
Recruiting
San Diego Clinical Trials
| La Mesa, California, 91942, United States
Recruiting
OM Research
| Lancaster, California, 93534, United States
Recruiting
Children's Hospital of Los Angeles
| Los Angeles, California, 90027, United States
Recruiting
Southern California Research Institute Medical Group, Inc.
| Los Angeles, California, 90045, United States
Completed
Matrix Clinical Research Inc
| Los Angeles, California, 90048, United States
Recruiting
Gastrointestinal Biosciences
| Los Angeles, California, 90067, United States
Recruiting
VA Northern California Health Care System
| Mather, California, 95655, United States
Not yet recruiting
Facey Medical Foundation (Parent)
| Mission Hills, California, 91345, United States
Completed
ABS Health, LLC
| Mission Viejo, California, 92691, United States
Completed
Alliance Clinical Research
| Oceanside, California, 92056, United States
Completed
Palo Alto Center-Palo Alto Medical Foundation Research Institute
| Palo Alto, California, 94304, United States
Completed
Havana Research Institute LLC
| Pasadena, California, 91105, United States
Completed
Inland Empire Liver Foundation
| Rialto, California, 92377, United States
Recruiting
Sutter Medical Group
| Roseville, California, 95661, United States
Completed
UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit
| Sacramento, California, 95817, United States
Recruiting
Medical Associates Research Group
| San Diego, California, 92123, United States
Recruiting
University of California at San Francisco
| San Francisco, California, 94158, United States
Recruiting
New Hope Research Development
| West Covina, California, 91790, United States
Completed
Peak Gastroenterology Associates
| Colorado Springs, Colorado, 80907, United States
Recruiting
Connecticut Clinical Research Foundation
| Bristol, Connecticut, 06010, United States
Recruiting
Yale University
| New Haven, Connecticut, 06510, United States
Recruiting
Gastro Florida
| Clearwater, Florida, 33756-3839, United States
Recruiting
Clinical Research of West Florida
| Clearwater, Florida, 33765, United States
Recruiting
South Lake Pain Institute
| Clermont, Florida, 34711, United States
Completed
American Research Institute Inc
| Cutler Bay, Florida, 33157, United States
Completed
Universal Axon Clinical Research
| Doral, Florida, 33166, United States
Recruiting
Riverside Clinical Research
| Edgewater, Florida, 32132, United States
Completed
University of Florida Health Endocrinology - Medical Specialties - Medical Plaza
| Gainesville, Florida, 32608, United States
Recruiting
Qway Research LLC
| Hialeah, Florida, 33010, United States
Not yet recruiting
Floridian Clinical Research LLC
| Hialeah, Florida, 33016, United States
Recruiting
Harmony Medical Research Institute
| Hialeah, Florida, 33016, United States
Completed
The Center for Gastrointestinal Disorders
| Hollywood, Florida, 33021, United States
Recruiting
Vista Health Research
| Homestead, Florida, 33033, United States
Recruiting
SIH Research
| Kissimmee, Florida, 34759, United States
Recruiting
Florida Center for Gastroenterology
| Largo, Florida, 33777, United States
Recruiting
Pioneer Clinical Research
| Lighthouse Point, Florida, 33064, United States
Recruiting
Center For Advanced Gastroenterology
| Maitland, Florida, 32751, United States
Completed
Galiz Research LLC
| Miami Springs, Florida, 33166, United States
Recruiting
LMG Research
| Miami, Florida, 33125, United States
Completed
Nova Clinical Research Center LLC
| Miami, Florida, 33125, United States
Recruiting
LCC Medical Research Institute, LLC
| Miami, Florida, 33126, United States
Completed
Research Associates of South Florida LLC
| Miami, Florida, 33156, United States
Recruiting
Life Medical Center & Research, Inc.
| Miami, Florida, 33166, United States
Recruiting
Vista Health Research
| Miami, Florida, 33176, United States
Recruiting
Advanced Research for Health Improvement
| Naples, Florida, 34109, United States
Recruiting
Bayside Clinical Research
| New Port Richey, Florida, 34655, United States
Recruiting
NSB Research
| New Smyrna Beach, Florida, 32168, United States
Recruiting
Omega Research Maitland, LLC
| Orlando, Florida, 32810, United States
Recruiting
HMD Research LLC
| Orlando, Florida, 32819, United States
Recruiting
IMIC, Inc.
| Palmetto Bay, Florida, 33157, United States
Recruiting
Theia Clinical Research, LLC
| Pinellas Park, Florida, 33781, United States
Completed
Advanced Medical Research Center
| Port Orange, Florida, 32127, United States
Recruiting
Precision Clinical Research, LLC.
| Sunrise, Florida, 33351, United States
Active, not recruiting
University of South Florida
| Tampa, Florida, 33612-4799, United States
Recruiting
Apex Clinical Research
| Tampa, Florida, 33612, United States
Completed
Guardian Angel Health Svcs Inc
| Tampa, Florida, 33614, United States
Recruiting
Asclepes Research Centers
| Weeki Wachee, Florida, 34607, United States
Recruiting
Consultative Gastroenterology
| Atlanta, Georgia, 30308, United States
Recruiting
Children's Healthcare of Atlanta
| Atlanta, Georgia, 30322, United States
Not yet recruiting
Emory Clinic
| Atlanta, Georgia, 30322, United States
Recruiting
Atlanta Gastroenterology Associates, LLC
| Atlanta, Georgia, 30342, United States
Recruiting
Children's Center for Digestive Healthcare
| Atlanta, Georgia, 30342, United States
Recruiting
Gastrointestinal Disease Research
| Columbus, Georgia, 31904, United States
Recruiting
Atlanta Center For Gastroenterology, P.C.
| Decatur, Georgia, 30030, United States
Recruiting
Gastroenterology Associates Of Central Georgia LLC
| Macon, Georgia, 31201, United States
Recruiting
Grand Teton Research Group, PLLC
| Idaho Falls, Idaho, 83404, United States
Recruiting
Rush University Medical Center - University Cardiovascular Surgeons
| Chicago, Illinois, 60612, United States
Recruiting
Northwestern University
| Chicago, Illinois, 60622, United States
Recruiting
University of Chicago
| Chicago, Illinois, 60637, United States
Recruiting
DM Clinical Research
| Oak Lawn, Illinois, 60453-3767, United States
Recruiting
Carle Foundation Hospital
| Urbana, Illinois, 61801, United States
Recruiting
MediSphere Medical Research Center, LLC
| Evansville, Indiana, 47714, United States
Recruiting
Indiana University
| Indianapolis, Indiana, 46202, United States
Recruiting
Iowa Digestive Disease Center
| Clive, Iowa, 50325, United States
Completed
Cotton ONeil Clinical Research Center Digestive Health
| Topeka, Kansas, 66606, United States
Recruiting
University of Kentucky Health Care
| Lexington, Kentucky, 40536, United States
Not yet recruiting
Gastroenterology Associates, LLC
| Baton Rouge, Louisiana, 70809, United States
Recruiting
CroNOLA LLC
| Houma, Louisiana, 70360, United States
Completed
Centex Studies, Inc.
| Lake Charles, Louisiana, 70601, United States
Recruiting
Clinical Trials of SW Louisiana LLC
| Lake Charles, Louisiana, 70601, United States
Recruiting
Tandem Clinical Research, LLC
| Marrero, Louisiana, 70072, United States
Completed
Nola Research Works
| New Orleans, Louisiana, 70125, United States
Recruiting
LSU Health Sciences Center Shreveport
| Shreveport, Louisiana, 71103, United States
Not yet recruiting
Johns Hopkins Bayview Medical Center
| Baltimore, Maryland, 21224, United States
Not yet recruiting
Digestive Disease Associates, PA
| Catonsville, Maryland, 21228, United States
Recruiting
Woodholme Gastroenterology Associates
| Glen Burnie, Maryland, 21061, United States
Not yet recruiting
Harvard Medical School - Boston Children's Hospital
| Boston, Massachusetts, 02115, United States
Not yet recruiting
Brigham and Women's Hospital - Crohn's and Colitis Center
| Chestnut Hill, Massachusetts, 02467, United States
Recruiting
Baystate Medical Center
| Springfield, Massachusetts, 01199, United States
Recruiting
University of Massachusetts Memorial Medical Center
| Worcester, Massachusetts, 01655, United States
Recruiting
Medex Research Institute
| Caro, Michigan, 48723, United States
Recruiting
Western Michigan University Homer Stryker M.D. School of Medicine
| Kalamazoo, Michigan, 49008, United States
Recruiting
Henry Ford Medical Center - New Center One
| Novi, Michigan, 48377, United States
Recruiting
Revive Research Institute
| Southfield, Michigan, 48034, United States
Recruiting
University of Minnesota Medical Center
| Minneapolis, Minnesota, 55455, United States
Recruiting
Mayo Clinic
| Rochester, Minnesota, 55905, United States
Recruiting
Southern Therapy and Advanced Research
| Jackson, Mississippi, 39216, United States
Recruiting
Mid America Gastrointestinal Consultants
| Kansas City, Missouri, 64111, United States
Recruiting
Washington University School of Medicine
| Saint Louis, Missouri, 63110, United States
Recruiting
Internal Medicine Specialists
| Las Vegas, Nevada, 89145, United States
Completed
Dartmouth-Hitchcock Medical Center
| Lebanon, New Hampshire, 03756, United States
Recruiting
Englewood Hospital and Medical Center
| Englewood, New Jersey, 07631, United States
Recruiting
University of New Mexico Hospital
| Albuquerque, New Mexico, 87106, United States
Not yet recruiting
Advantage Clinical Trials
| Bronx, New York, 10468, United States
Completed
NY Scientific
| Brooklyn, New York, 11235, United States
Recruiting
Adirondack Medical Research Center
| Glens Falls, New York, 12801, United States
Not yet recruiting
Northwell Health
| Great Neck, New York, 11021, United States
Recruiting
Drug Trials America
| Hartsdale, New York, 10530, United States
Recruiting
Weill Cornell Medical College
| New York, New York, 10010, United States
Completed
Concorde Medical Group
| New York, New York, 10016, United States
Completed
Cornell University
| New York, New York, 10021, United States
Recruiting
TrialSpark
| New York, New York, 10024, United States
Completed
Lenox Hill Hospital
| New York, New York, 10075, United States
Recruiting
DiGiovanna Institute for Medical Education And Research
| North Massapequa, New York, 11758-1802, United States
Recruiting
Circuit Clinical
| Orchard Park, New York, 14127, United States
Completed
Asheville Gastroenterology Associates, P.A.
| Asheville, North Carolina, 28801, United States
Recruiting
Carolinas HealthCare System Digestive Health
| Charlotte, North Carolina, 28204, United States
Recruiting
Internal Medicine Research
| Charlotte, North Carolina, 28207, United States
Recruiting
PMG Research of Charlotte LLC
| Charlotte, North Carolina, 28209, United States
Recruiting
Carolina Research Center
| Greenville, North Carolina, 27834, United States
Recruiting
PMG Research of Winston-Salem LLC
| Winston-Salem, North Carolina, 27103, United States
Recruiting
Great Lakes Medical Research, LLC
| Beachwood, Ohio, 44122, United States
Recruiting
University Hospitals of Cleveland
| Cleveland, Ohio, 44106-5000, United States
Not yet recruiting
Cleveland Clinic - Taussig Cancer Institute
| Cleveland, Ohio, 44195, United States
Recruiting
Advance Clinical Research - Dayton Internal Medicine
| Dayton, Ohio, 45417, United States
Recruiting
Ohio State University Wexner Medical Center
| Hilliard, Ohio, 43026, United States
Recruiting
Great Lakes Gastroenterology
| Mentor, Ohio, 44060, United States
Recruiting
Paramount Medical Research & Consulting, LLC
| Middleburg Heights, Ohio, 44130, United States
Completed
Great Lakes Medical Research, LLC
| Warren, Ohio, 44483, United States
Completed
Cancer Care Associates of OK-N PorterAvenue
| Norman, Oklahoma, 73071, United States
Recruiting
University of Oklahoma Health Sciences Center
| Oklahoma City, Oklahoma, 73104, United States
Not yet recruiting
Digestive Disease Specialists
| Oklahoma City, Oklahoma, 73112, United States
Recruiting
Allergy, Asthma and Immunology Center, PC
| Tulsa, Oklahoma, 74136, United States
Recruiting
Central States Research, LLC
| Tulsa, Oklahoma, 74136, United States
Recruiting
Oregon Health & Science University
| Portland, Oregon, 97239, United States
Recruiting
Penn State Milton S Hershey Medical Center
| Hershey, Pennsylvania, 17033, United States
Recruiting
University of Pennsylvania Cancer Center
| Philadelphia, Pennsylvania, 19104, United States
Recruiting
Penn State University Milton S Hershey Medical Center
| State College, Pennsylvania, 16803, United States
Completed
Gastroenterology Associates of Orangeburg
| Orangeburg, South Carolina, 29118, United States
Recruiting
Quality Medical Research
| Nashville, Tennessee, 37211, United States
Completed
Vanderbilt University Medical Center
| Nashville, Tennessee, 37212, United States
Recruiting
Advanced Gastroenterology
| Union City, Tennessee, 38261, United States
Completed
Avant Research Associates, LLC - Austin
| Austin, Texas, 78742, United States
Recruiting
San Antonio Military Medical Center
| Fort Sam Houston, Texas, 78234, United States
Recruiting
Baylor College of Medicine
| Houston, Texas, 77030, United States
Recruiting
Houston Methodist Hospital
| Houston, Texas, 77030, United States
Recruiting
Biopharma Informatic Inc. Research Center
| Houston, Texas, 77043, United States
Completed
Centex Studies, Inc.
| Houston, Texas, 77058, United States
Completed
GI Specialists of Houston
| Houston, Texas, 77070, United States
Completed
Premier Vein and Vascular Center
| Houston, Texas, 77084, United States
Completed
The Coastal Medical Group
| Houston, Texas, 77089, United States
Recruiting
Gulf Coast Research Group LLC
| Houston, Texas, 77098, United States
Completed
Accurate Clinical Research Inc
| Pasadena, Texas, 77505, United States
Completed
DHAT Research Institute
| Richardson, Texas, 75082, United States
Recruiting
Sun Research Institute
| San Antonio, Texas, 78215, United States
Recruiting
San Antonio Gastroenterology
| San Antonio, Texas, 78229, United States
Recruiting
Texas Digestive Disease Consultants - Southlake
| Southlake, Texas, 76092, United States
Recruiting
Baylor Scott and White Health
| Temple, Texas, 76508, United States
Recruiting
Digestive Health Specialists of Tyler
| Tyler, Texas, 75701, United States
Recruiting
University of Utah School of Medicine
| Salt Lake City, Utah, 84132, United States
Recruiting
Gastroenterology Associates, PC
| Gainesville, Virginia, 20155, United States
Recruiting
Blue Ridge Medical Research
| Lynchburg, Virginia, 24502, United States
Recruiting
Summit Clinical Research, LLC
| Petersburg, Virginia, 23805, United States
Completed
The Gastroenterology Group
| Reston, Virginia, 20191, United States
Completed
McGuire Veterans Affairs Medical Center
| Richmond, Virginia, 23249, United States
Recruiting
Carilion Clinic
| Roanoke, Virginia, 24016, United States
Recruiting
Virginia Gastroenterology Institute PC
| Suffolk, Virginia, 23434, United States
Completed
University of Washington Medical Center
| Seattle, Washington, 98195, United States
Not yet recruiting
Dermatologist Specialists of Spokane
| Spokane, Washington, 99204, United States
Recruiting
Aurora Health Care Aurora Research
| Grafton, Wisconsin, 53024, United States
Completed
Franciscan Skemp Healthcare
| La Crosse, Wisconsin, 54601, United States
Recruiting
Sanatorio Guemes
| Ciudad Autonoma de Buenos Aires, 1180, Argentina
Recruiting
Hospital Privado Centro Medico de Cordoba
| Cordoba, X5016, Argentina
Recruiting
Instituto Medico de la Fundacion Estudios Clinicos
| Rosario, 2000, Argentina
Completed
Universidad Nacional De Rosario - Hospital Provincial Del Centenario
| Rosario, 2000, Argentina
Not yet recruiting
Sanatorio 9 de Julio - CICE 9 de Julio
| San Miguel de Tucuman, 4000, Argentina
Recruiting
Concord Repatriation General Hospital
| Concord, New South Wales, 2139, Australia
Recruiting
Nepean Hospital
| Kingswood, New South Wales, 2747, Australia
Recruiting
Liverpool Hospital
| Liverpool, New South Wales, 2170, Australia
Recruiting
John Hunter Hospital and Hunter Medical Research Institute
| New Lambton Heights, New South Wales, 2305, Australia
Recruiting
Wollongong Hospital
| Wollongong, New South Wales, 2500, Australia
Recruiting
Coastal Digestive Health
| Maroorchydore, Queensland, 4558, Australia
Recruiting
University of the Sunshine Coast
| North Mackay, Queensland, 4740, Australia
Completed
Mater Hospital Brisbane
| South Brisbane, Queensland, 4101, Australia
Recruiting
Princess Alexandra Hospital
| Woolloongabba, Queensland, 4102, Australia
Recruiting
Royal Adelaide Hospital
| Adelaide, South Australia, 5000, Australia
Recruiting
Flinders Medical Centre
| Bedford Park, South Australia, 5042, Australia
Recruiting
The Queen Elizabeth Hospital
| Woodville South, South Australia, 5011, Australia
Recruiting
Monash Medical Centre
| Clayton, Victoria, 3168, Australia
Recruiting
St Vincent's Hospital Melbourne
| Fitzroy, Victoria, 3065, Australia
Recruiting
Harry Perkins Medical Research Institute, Fiona Stanley Hospital
| Murdoch, Western Australia, 6150, Australia
Recruiting
St John of God Subiaco Hospital
| Subiaco, Western Australia, 6008, Australia
Completed
Ballarat Base Hospital
| Ballarat, 3350, Australia
Not yet recruiting
Medical University Innsbruck
| Innsbruck, 6020, Austria
Recruiting
University Hospital St. Poelten
| St Polten, 3100, Austria
Recruiting
Medical University Vienna
| Vienna, 1090, Austria
Recruiting
Grodno City Clinical Hospital #4
| Grodno, 230026, Belarus
Recruiting
Vitebsk Regional Clinical Specialized Center
| Vitebsk, 210604, Belarus