Индукционное исследование №1 перорального приема озанимода в качестве индукционной терапии для умеренно или сильно активной болезни Крона

Название протокола
Клинические исследование Болезнь Крона: Ozanimod, Плацебо - 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 исследование посвящено изучению эффекта перорального озанимода в качестве индукционной терапии для участники с болезнью Крона в активной или тяжелой форме.

Общий статус Рекрутинг
Дата начала 2018-02-27
Дата завершения 2023-09-25
Дата первичного завершения 2023-06-27
Фаза Фаза 3
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Доля участников с индексом активности болезни Крона (CDAI) <150 Неделя 12
Вторичный результат
Мера Временное ограничение
Proportion of participants with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline Week 12
Доля участников с простой эндоскопической оценкой болезни Крона (SES-CD) уменьшилась по сравнению с исходным уровнем на ≥ 50% Неделя 12
Доля участников со снижением CDAI по сравнению с исходным уровнем на ≥ 100 баллов или с показателем CDAI <150 Неделя 12
Доля участников со снижением CDAI от исходного уровня на ≥ 100 баллов или с показателем CDAI <150 и снижением SES-CD от исходного уровня на ≥ 50% Неделя 12
Доля участников с показателем CDAI <150 и снижением SES-CD по сравнению с исходным уровнем на ≥ 50% Неделя 12
Доля участников со средней суточной оценкой боли в животе ≤ 1 балла и средней суточной оценкой частоты стула ≤ 3 балла, и оба показателя не хуже, чем исходный уровень, И SES-CD ≤ 4 балла и снижение ≥2 балла Неделя 12
Доля участников со средней суточной оценкой боли в животе ≤ 1 балла и средней суточной частотой стула ≤ 3 балла, и оба показателя не хуже, чем исходный уровень, И снижение SES-CD по сравнению с исходным уровнем ≥ 50% Неделя 12
Гистологическое улучшение, основанное на различиях между озанимодом и плацебо в оценках гистологической активности заболевания (т. Е. Изменения Глобальной оценки активности гистологического заболевания) Неделя 12
Доля участников со снижением CDAI от исходного уровня ≥ 70 баллов Неделя 12
Доля участников без язв ≥ 0,5 см без сегмента с любой изъязвленной поверхностью ≥ 10% Неделя 12
Доля участников со снижением эндоскопического индекса тяжести болезни Крона (CDEIS) по сравнению с исходным уровнем на ≥ 50% Неделя 12
Регистрация 600
Состояние
  • Болезнь Крона
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Ozanimod

Описание: Specified dose on specified days

Этикетка Arm Group: Administration of oral Ozanimod

Тип вмешательства: Другой

Название вмешательства: Плацебо

Описание: Указанная доза в указанные дни

Этикетка Arm Group: Введение плацебо

Приемлемость

Критерии:

Для получения дополнительной информации об участии в клиническом исследовании Bristol-Myers Squibb, пожалуйста, посетите: www.BMSStudyConnect.com Критерии включения: - Болезнь Крона ≥ 3 месяцев при эндоскопии и гистологическом исследовании - Неадекватный ответ или потеря ответа на кортикостероиды, иммуномодуляторы и / или биологическая терапия - Индекс активности болезни Крона (CDAI) ≥ 220 и ≤ 450 - Средняя дневная частота стула ≥ 4 балла и / или боль в животе ≥ 2 балла - Имеет ≥ 6 баллов по простой эндоскопической шкале болезни Крона (SES-CD) (или SES-CD ≥ 4 у участников с изолированным заболеванием подвздошной кишки) Критерий исключения: - Имеет диагноз язвенный колит, неопределенный колит, лучевой колит или ишемический колит или стриктуры с престенотической дилатацией, требующие процедурного вмешательство - Имеет обширную резекцию тонкой кишки (> 100 см) или известный диагноз короткой кишки. синдром или требуется полное парентеральное питание - Текущая стома, анастомоз подвздошно-анального мешка или свищ Применяются другие критерии включения / исключения, определенные протоколом

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 sites 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
Arkansas Gastroenterology, P.A. | North Little Rock, Arkansas, 72117, United States Recruiting
Sharp Chula Vista Medical Center | Chula Vista, California, 91911, United States Recruiting
Valley View Internal Medicine | Garden Grove, California, 92843, United States Recruiting
San Diego Clinical Trials | La Mesa, California, 91942, United States Recruiting
Children's Hospital of Los Angeles | Los Angeles, California, 90027, 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
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
Inland Empire Liver Foundation | Rialto, California, 92377, United States Recruiting
Medical Associates Research Group | San Diego, California, 92123, United States Recruiting
Childrens Hospital Colorado | Aurora, Colorado, 80045, United States Not yet recruiting
Yale University | New Haven, Connecticut, 06510, United States Recruiting
Gastro Florida | Clearwater, Florida, 33756-3839, United States Recruiting
University of Florida Health Endocrinology - Medical Specialties - Medical Plaza | Gainesville, Florida, 32608, United States Recruiting
Qway Research LLC | Hialeah, Florida, 33010, United States 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
Florida Center for Gastroenterology | Largo, Florida, 33777, United States Recruiting
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
Advanced Research for Health Improvement | Naples, Florida, 34109, United States Recruiting
NSB Research | New Smyrna Beach, Florida, 32168, United States Recruiting
HMD Research LLC | Orlando, Florida, 32819, United States Recruiting
Advanced Medical Research Center | Port Orange, Florida, 32127, United States Recruiting
Asclepes Research Centers | Weeki Wachee, Florida, 34607, United States Recruiting
Consultative Gastroenterology | Atlanta, Georgia, 30308, 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
Gastroenterology Associates Of Central Georgia LLC | Macon, Georgia, 31201, United States Recruiting
Rush University Medical Center - University Cardiovascular Surgeons | Chicago, Illinois, 60612, United States Recruiting
Northwestern University | Chicago, Illinois, 60622, United States Recruiting
Carle Foundation Hospital | Urbana, Illinois, 61801, United States Recruiting
Iowa Digestive Disease Center | Clive, Iowa, 50325, United States Completed
University of Kentucky Health Care | Lexington, Kentucky, 40536, United States Recruiting
CroNOLA LLC | Houma, Louisiana, 70360, United States Completed
Centex Studies, Inc. | Lake Charles, Louisiana, 70601, United States Recruiting
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 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
Medex Research Institute | Caro, Michigan, 48723, United States Recruiting
Revive Research Institute | Southfield, Michigan, 48034, United States Recruiting
Southern Therapy and Advanced Research | Jackson, Mississippi, 39216, United States Recruiting
Washington University School of Medicine | Saint Louis, Missouri, 63110, 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
Cornell University | New York, New York, 10021, United States Recruiting
Lenox Hill Hospital | New York, New York, 10075, 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
Carolina Research Center | Greenville, North Carolina, 27834, United States Recruiting
Great Lakes Medical Research, LLC | Beachwood, Ohio, 44122, United States Recruiting
Cleveland Clinic - Taussig Cancer Institute | Cleveland, Ohio, 44195, United States Recruiting
Great Lakes Gastroenterology | Mentor, Ohio, 44060, United States Recruiting
Great Lakes Medical Research, LLC | Warren, Ohio, 44483, United States Completed
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, 73104, United States Recruiting
Digestive Disease Specialists | Oklahoma City, Oklahoma, 73112, 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
Penn State University Milton S Hershey Medical Center | State College, Pennsylvania, 16803, United States Completed
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
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
GI Specialists of Houston | Houston, Texas, 77070, United States Completed
Premier Vein and Vascular Center | Houston, Texas, 77084, United States Completed
Sun Research Institute | San Antonio, Texas, 78215, United States Recruiting
Texas Digestive Disease Consultants - Southlake | Southlake, Texas, 76092, 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
Summit Clinical Research, LLC | Petersburg, Virginia, 23805, United States Completed
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
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 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
Wollongong Hospital | Wollongong, New South Wales, 2500, Australia Recruiting
Princess Alexandra Hospital | Woolloongabba, Queensland, 4102, Australia Recruiting
Royal Adelaide Hospital | Adelaide, South Australia, 5000, Australia Recruiting
The Queen Elizabeth Hospital | Woodville South, South Australia, 5011, Australia Recruiting
Harry Perkins Medical Research Institute, Fiona Stanley Hospital | Murdoch, Western Australia, 6150, Australia Recruiting
Ballarat Base Hospital | Ballarat, 3350, Australia Not yet recruiting
Grodno City Clinical Hospital #4 | Grodno, 230026, Belarus Recruiting
Vitebsk Regional Clinical Specialized Center | Vitebsk, 210604, Belarus Recruiting
Algemeen Ziekenhuis Klina | Brasschaat, 2930, Belgium Recruiting
Universitair Ziekenhuis Brussel | Brussels, 1090, Belgium Recruiting
University Hospital Brussels | Brussels, 1090, Belgium Not yet recruiting
CHU Saint-Luc | Brussels, 1200, Belgium Not yet recruiting
Queen Fabiola Children's University Hospital | Brussels, 1200, Belgium Not yet recruiting
Universitair Ziehenhuis Antwerpen | Edegem, 2650, Belgium Recruiting
Universitair Ziekenhuis Gent | Ghent, 9000, Belgium Recruiting
Universitair Ziekenhuis Leuven, Campus Gasthuisberg | Leuven, 3000, Belgium Recruiting
Clinique du Montlegia | Liege, 4000, Belgium Recruiting
Sart Tilman Hospital Department of Gastroenterology and Hepatology | Seraing, 4100, Belgium Recruiting
Hospital Centre of Walloon Picarde | Tournai, 7500, Belgium Recruiting
University Clinical Centre of the Republic of Srpska | Banja Luka, 78000, Bosnia and Herzegovina Recruiting
University Clinical Hospital Mostar | Mostar, 88000, Bosnia and Herzegovina Completed
Clinical Center University of Sarajevo | Sarajevo, 71000, Bosnia and Herzegovina Completed
General Hospital "Prim.dr. Abdulah Nakas" | Sarajevo, 71000, Bosnia and Herzegovina Recruiting
Multiprofile Hospital for Active Treatment Medline | Plovdiv, 4002, Bulgaria Recruiting
Second MHAT Sofia AD | Sofia, 1202, Bulgaria Recruiting
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD | Sofia, 1606, Bulgaria Recruiting
University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia | Sofia, 1784, Bulgaria Recruiting
ACIBADEM City Clinic Medical Center Bregalnitsa | Varna, 9002, Bulgaria Completed
University of Calgary Health - The Gastrointestinal Research Group (GIRG) | Calgary, Alberta, T2N 4Z6, Canada Recruiting
Okanagan Clinical Trials Ltd | Kelowna, British Columbia, V1Y 1Z9, Canada Completed
Vancouver Hospital Gastrointestinal Research Unit The Gordon and Leslie Diamond Centre | Vancouver, British Columbia, V5Z1M9, Canada Completed
Winnipeg Clinic Dermatology Research | Winnipeg, Manitoba, R3CON2, Canada Completed
Viable Clinical Research | Bridgewater, Nova Scotia, B4V 3N2, Canada Recruiting
London Health Sciences Centre, University Hospital | London, Ontario, N6A 5A5, Canada Recruiting
LHSC Victoria Hospital | London, Ontario, N6A 5W9, Canada Recruiting
Toronto Digestive Disease Associates Inc | Vaughan, Ontario, L4L 4Y7, Canada Recruiting
Clinical Hospital Center Osijek | Osijek, 31000, Croatia Recruiting
Clinical Hospital Centre Rijeka | Rijeka, 51000, Croatia Completed
Clinical Hospital Center Split | Split, HR-21000, Croatia Recruiting
Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases | Zagreb, 10000, Croatia Recruiting
Clinical Hospital Dubrava | Zagreb, 10000, Croatia Completed
University Hospital Centre Zagreb, Clinic of Internal Diseases | Zagreb, 10000, Croatia Recruiting
Military Hospital Brno | Brno, 615 00, Czechia Recruiting
St. Anne's University Hospital Brno | Brno, 656 91, Czechia Recruiting
Hepato-Gastroenterologie HK, s. r. o. | Hradec Králové, 500 12, Czechia Recruiting
Soukroma Gastroenterologicka ambulance a endoskopie | Most, 43401, Czechia Recruiting
PreventaMed | Olomouc, 77900, Czechia Recruiting
Krajská nemocnice Pardubice, Kožní oddelení | Pardubice, 532 03, Czechia Recruiting
University Hospital Pilsen | Plzen, 30460, Czechia Recruiting
University Hospital Motol | Prague 5, 150 06, Czechia Completed
ISCARE, a.s. | Prague 9, 190 00, Czechia Recruiting
Institut klinicke a experimentalni mediciny | Praha 4, 14021, Czechia Recruiting
Bispebjerg Hospital | Copenhagen, 2400, Denmark Completed
Holbaek Hospital | Holbaek, 4300, Denmark Completed
Nykobing F Hospital | Nykobing F, 4800, Denmark Completed
Turku University Hospital | Turku, FI-20520, Finland Recruiting
CHU Amiens Picardie - Site Sud | Amiens cedex 1, 80054, France Recruiting
Centre Hospitalier Intercommunal de Creteil | Creteil Cedex, 94010, France Recruiting
CHU de Dijon Bourgogne - Hopital Francois Mitterand | Dijon Cedex, 21079, France Recruiting
CHU de Grenoble Alpes | Grenoble Cedex 9, 38700, France Recruiting
CHRU de Lille - Hopital Claude Huriez | Lillie Cedex, 59037, France Recruiting
Hopital Nord | Marseille cedex 20, 13915, France Not yet recruiting
Hospital Pontchaillou | Rennes, 35033, France Recruiting
CHU de Rouen Hopital Charles Nicolle | Rouen Cedex, 76031, France Recruiting
CHU de Toulouse Hopital Rangueil | Toulouse Cedex 09, 31059, France Recruiting
Charite - Universitaetsmedizin Berlin | Berlin, 10117, Germany Recruiting
Gastroenterology Am Bayerischen Platz | Berlin, 10825, Germany Recruiting
DRK Clinics Berlin | Berlin, 14050, Germany Recruiting
Agaplesion Markus Krankenhaus | Frankfurt, 60431, Germany Recruiting
Interdisciplinary Crohn Colitis Center Rhein Main | Frankfurt, 60594, Germany Recruiting
University Hospital Hamburg-Eppendorf | Hamburg, 20246, Germany Recruiting
Universitaetsklinikum Leipzig AoeR | Leipzig, 04103, Germany Recruiting
Practice for Gastroenterology and Internal Medicine | Ludwigshafen am Rhein, 67067, Germany Recruiting
St Marien und St Annastiftskrankenhaus | Ludwigshafen am Rhein, 67067, Germany Recruiting
Synesis Research Center | Munich, 80331, Germany Not yet recruiting
Universitaetsklinikum Tuebingen | Tuebingen, 72076, Germany Recruiting
Universitaetsklinikum Ulm | Ulm, 89081, Germany Recruiting
St Vincent's University Hospital | Dublin 4, Dublin, DO4 T6F4, Ireland Recruiting
Beaumont Hospital | Dublin 9, D09 V2N0, Ireland Recruiting
Bat Yamon Medical Center, Clalit Medical Services | Bat Yam, 5962025, Israel Completed
Shaare Zedek Medical Center | Jerusalem, 91031, Israel Recruiting
Galilee Medical Center | Nahariya, 22100, Israel Recruiting
Chaim Sheba Medical Center | Ramat Gan, 52621, Israel Recruiting
Kaplan Medical Center | Rechovot, 76100, Israel Recruiting
University Polyclinic Hospital of Bari | Bari, 70124, Italy Not yet recruiting
Polyclinic S. Orsola-Malpighi | Bologna, 40138, Italy Recruiting
Civil Hospital of Brescia | Brescia, 25123, Italy Recruiting
Poliambulanza Hospital | Brescia, 25124, Italy Recruiting
IRCCS "Savario De Bellis" | Castellana Grotte, 70013, Italy Recruiting
University Hospital Mater Domini | Catanzaro, 88100, Italy Recruiting
"Ss. Annunziata" Policlinic of Chieti | Chieti, 66100, Italy Recruiting
University Polyclinic Hospital G. Martino | Messina, 98125, Italy Recruiting
Maggiore Polyclinic Hospital, IRCCS Ca' Granda | Milano, 20122, Italy Completed
Humanitas Research Hospital - Humanitas Mirasole S.p.A | Milan, 20089, Italy Recruiting
Azienda Socio Sanitaria Territoriale (ASST) di Monza | Monza, 20900, Italy Recruiting
Hospital of Di Padova | Padova, 35128, Italy Recruiting
United Hospitals Villa Sofia Cervello | Palermo, 90146, Italy Recruiting
Polyclinic San Matteo IRCCS | Pavia, 27100, Italy Recruiting
Polyclinic Tor Vergata | Roma, 00133, Italy Recruiting
Univerisity Polyclinic Foundation Agostino Gemelli | Roma, 00168, Italy Recruiting
Azienda Ospedaliera San Camillo Forlanini | Rome, 00152, Italy Recruiting
Integrated University Hospital Santa Maria della Misericordia of Udine | Udine, 33100, Italy Recruiting
A.O. Universitaria Fondazione Macchi | Varese, 21100, Italy Recruiting
Sacred Heart Don Calabria | Verona, 37024, Italy Recruiting
Korea University Medical Center - Korea University Ansan Hospital | Ansan, 152-703, Korea, Republic of Completed
Hanyang University Guri Hospital | Guri-si, 11923, Korea, Republic of Recruiting
Seoul National University Bundang Hospital | Seongnam-si, 13620, Korea, Republic of Recruiting
Severance Hospital | Seoul, 120-752, Korea, Republic of Recruiting
Samsung Medical Center | Seoul, 135-710, Korea, Republic of Recruiting
Kangbuk Samsung Hospital | Seoul, 3181, Korea, Republic of Recruiting
Ewha Womans University Mokdong Hospital | Seoul, 7985, Korea, Republic of Recruiting
P. Stradins Clinical University Hospital | Riga, LV-1002, Latvia Recruiting
Digestive Diseases Center Gastro | Riga, LV-1006, Latvia Recruiting
Riga East Clinical University Hospital clinic Gailezers | Riga, LV-1038, Latvia Recruiting
Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V. | Zapapan, Jalisco, 45030, Mexico Recruiting
Centro Regiomontano de Estudios Clinicos Roma SC. | Monterrey, Nuevo León, 64610, Mexico Recruiting
Instituto Tecnológico y de Estudios Superiores de Monterrey | Monterrey, Nuevo León, 64718, Mexico Recruiting
SMIQ | Santiago de Queretaro, Querétaro, 76070, Mexico Recruiting
Hospital Christus Muquerza del Parque S.A. de C.V. | Chihuahua, 31020, Mexico Recruiting
Centro de Investigacion Clinica Acelerada (CICA) S.C. | Mexico, 07020, Mexico Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Tlalpan, 14080, Mexico Recruiting
"Sfanta Treime" Clinical Municipal Hospital | Chisinau, MD-2068, Moldova, Republic of Recruiting
Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery | Chisinau, MD2005, Moldova, Republic of Completed
"Sf. Arhanghel Mihail" Municipal Clinical Hospital | Chisinau, MD2025, Moldova, Republic of Recruiting
Republican Clinical Hospital, Department of Colorectal Surgery | Chisinau, MD2025, Moldova, Republic of Recruiting
Republican Clinical Hospital | Chisinau, MD2025, Moldova, Republic of Recruiting
Akershus University Hospital | Lørenskog, 1478, Norway Not yet recruiting
Lovisenberg Diakonale Sykehus | Oslo, 0440, Norway Not yet recruiting
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego | Bialystok, 15-276, Poland Recruiting
Medical Services Center MaxMed | Bochnia, 32-700, Poland Recruiting
Nzoz All-Medicus | Katowice, 40-660, Poland Completed
Kornel Gibinski Independent Public Central Clinical Hospital in Katowice | Katowice, 40-752, Poland Recruiting
GLOBE Clinical Research Sp. z o.o. LLC | Klodzko, 57-300, Poland Recruiting
PLEJADY Sp. z o.o. (LLC) Medical Centre | Krakow, 30-363, Poland Recruiting
Landa Specialist Doctor's Offices | Krakow, 31-156, Poland Recruiting
Krakow Medical Center LLC | Krakow, 31-501, Poland Recruiting
Santa Familia Centrum Badan, Profilaktyki i Leczenia | Lodz, 90-302, Poland Recruiting
Salve Limited Liability Company Limited Partnership, Outpatient Clinic | Lodz, 91-839, Poland Recruiting
1 Military Clinical Hospital in Lublin | Lublin, 20-049, Poland Recruiting
Provincial Specialist Hospital in Olsztyn | Olsztyn, 10-561, Poland Recruiting
SOLUMED Medical Center | Poznan, 60-529, Poland Recruiting
GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe | Torun, 87-100, Poland Completed
H-T. Medical Center Sp. z o.o. LLC Limited Partnership | Tychy, 43-100, Poland Recruiting
Polimedica | Ul. Piotrkowska 177, 90-447, Poland Recruiting
Maternal Pediatric and Adolescent Healthcare Centre | Warsaw, 00-632, Poland Recruiting
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED | Warszawa, 03-580, Poland Completed
Hyperclinica MedLife Grivita | Bucharest, 010719, Romania Recruiting
Center of Diagnosis and Treatment Provita | Bucharest, 021494, Romania Recruiting
Fundeni Clinical Institute | Bucharest, 022328, Romania Recruiting
Bucharest University Emergency Hospital, Department of Internal Medicine II | Bucharest, 050098, Romania Recruiting
Dr. Carol Davila Central Military Emergency Clinical Hospital | Bucharest, 10825, Romania Recruiting
Craiova County Emergency Clinical Hospital | Craiova, 200642, Romania Recruiting
Colentina Clinical Hospital | Napoca, 400001, Romania Recruiting
Targu Mures County Emergency Clinical Hospital | Targu Mures, 540136, Romania Recruiting
Chita State Medical Academy | Chita, 672090, Russian Federation Recruiting
Irkutsk State Medical Academy of Postgraduate Education | Irkutsk, 664049, Russian Federation Recruiting
City Clinical Hospital No 7 - Kazan | Kazan, 420103, Russian Federation Recruiting
Regional Clinical Hospital | Khanty-mansiysk, 628012, Russian Federation Recruiting
Federal Siberian Research and Clinical Center | Krasnoyarsk, 660037, Russian Federation Recruiting
Moscow Clinical Scientific and Practical Center | Moscow, 111123, Russian Federation Completed
Novosibirskiy Gastrocenter | Novosibirsk, 630007, Russian Federation Recruiting
Republican Hospital na VA Baranov | Petrozavodsk, 185019, Russian Federation Recruiting
Evromedservis | Pushkin, 196603, Russian Federation Recruiting
Clinic UZI 4D, LLC | Pyatigorsk, 357502, Russian Federation Recruiting
Pyatigorsk City Hospital 2 | Pyatigorsk, 357538, Russian Federation Recruiting
Rostov State Medical University | Rostov-on-Don, 344022, Russian Federation Recruiting
Medical Center Reavita Med Spb LLC | Saint Petersburg, 194354, Russian Federation Completed
Samara Station Railway Clinical Hospital under OAO Russian Railways | Samara, 443041, Russian Federation Recruiting
S.M. Kirov Military Medical Academy | St Petersburg, 194044, Russian Federation Recruiting
Clinical and Diagnostic Center with an outpatient department under the Presidential Executive Office | St. Petersburg, 195067, Russian Federation Recruiting
SPb SBIH City Hospital of Saint Martyr Elizaveta | St. Petersburg, 195257, Russian Federation Recruiting
Budget Institution of the Khanty-Mansiysk Autonomous Okrug - Ugra Surgut Regional Clinical Hospital | Surgut, 628408, Russian Federation Not yet recruiting
Tula Regional Clinical Hospital | Tula, 300053, Russian Federation Recruiting
City Clinical Hospital #21 | Ufa, 450071, Russian Federation Recruiting
Ulyanovsk Regional Clinical Hospital | Ulyanovsk, 432017, Russian Federation Not yet recruiting
Novgorod Regional Clinical Hospital | Veliky Novgorod, 173008, Russian Federation Recruiting
Regional Clinical Hospital | Vladimir, 600023, Russian Federation Not yet recruiting
Primorsky Regional Clinical Hospital No.1 | Vladivostok, 690091, Russian Federation Recruiting
Medical Center of Far-Eastern Federal University | Vladivostok, 690922, Russian Federation Recruiting
King Fahad Specialist Hospital | Dammam, 32253, Saudi Arabia Completed
King Abdul Aziz University Hospital | Jeddah, 22252, Saudi Arabia Recruiting
King Saud Medical Complex | Riyadh, 12746, Saudi Arabia Recruiting
King Fahad National Guard Hospital | Riyadh, 14611, Saudi Arabia Recruiting
General University Hospital of Alicante | Alicante, 03010, Spain Recruiting
University Hospital Germans Trias i Pujol | Badalona, 08916, Spain Recruiting
University Hospital of the Canary Islands (HUC) La Laguna | La Laguna, 38320, Spain Recruiting
University Hospital de La Princesa | Madrid, 28006, Spain Recruiting
University Hospital La Paz | Madrid, 28046, Spain Recruiting
University Hospital Virgen Macarena | Sevilla, 41009, Spain Recruiting
University Hospital Virgen del Rocio | Sevilla, 41013, Spain Recruiting
Viladecans Hospital | Viladecans, 08840, Spain Recruiting
Lindenhofspital | Bern, 3001, Switzerland Recruiting
Cantonal Hospital Saint Gallen | St.Gallen, 9007, Switzerland Recruiting
University Hospital Zurich | Zurich, 8091, Switzerland Recruiting
Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi | Kozlu, 67000, Taiwan Recruiting
Ankara University Medical Faculty Cebeci Hospital | Ankara, 06590, Turkey Completed
Uludag Universitesi Tip Fakultesi | Bursa, 16059, Turkey Completed
Bezmialem Foundation University Medical Faculty | Istanbul, 34093, Turkey Recruiting
Marmara University | Istanbul, 34840, Turkey Completed
Goztepe Prof. Dr. Suleyman Yalcin City Hospital | Kadiköy/Istanbul, 41380, Turkey Recruiting
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi | Trabzon, 61080, Turkey Recruiting
Chernivtsi Regional Clinical Hospital | Chernivtsi, 58001, Ukraine Recruiting
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases | Dnipropetrovsk, 49074, Ukraine Recruiting
Ivano-Frankivsk Central City Clinical Hospital | Ivano-Frankivsk, 76018, Ukraine Recruiting
V.T. Zaitsev Institute of General and Emergency Surgery | Kharkiv, 61018, Ukraine Completed
Kyiv City Clinical Hospital #18 | Kyiv, 01030, Ukraine Recruiting
Medical Center Consilium Medical | Kyiv, 02000, Ukraine Recruiting
Ok Clinic Medical Center within International Institute of Clinical Trials, LLC | Kyiv, 02175, Ukraine Recruiting
Kyiv Regional Hospital #2 | Kyiv, 04053, Ukraine Recruiting
Kyiv Regional Clinical Hospital | Kyiv, 04107, Ukraine Recruiting
Public City Clinical Hospital of Emergency Medical Care | Lviv, 79059, Ukraine Completed
Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council | Poltava, 36011, Ukraine Recruiting
Ternopil City Public Emergency Medical Care Hospital | Ternopil, 46008, Ukraine Recruiting
Vinnytsia City Clinical Hospital #1 | Vinnytsia, 02029, Ukraine Recruiting
Vinnytsia M.I. Pyrohov Regional Clinical Hospital | Vinnytsia, 21018, Ukraine Recruiting
First Private Clinic | Zhytomyr, 10003, Ukraine Not yet recruiting
Bristol Royal Infirmary | Bristol, BS2 8HW, United Kingdom Completed
Ulster Hospital | Dundonald, BT16 1RH, United Kingdom Recruiting
Queen Elizabeth University Hospital | Glasgow, G51 4TF, United Kingdom Recruiting
Victoria Hospital Blackpool | Lancashire Blackpool, FY3 8NR, United Kingdom Recruiting
Royal London Hospital | London, E1 1BB, United Kingdom Recruiting
University College London Hospitals NHS Foundation Trust - University College Hospital | London, NW1 2BU, United Kingdom Not yet recruiting
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital | London, SE1 9RT, United Kingdom Recruiting
John Radcliffe Hospital | Oxford, OX3 9DU, United Kingdom Not yet recruiting
Royal Shrewsbury Hospital | Shrewsbury, SY38XQ, United Kingdom Not yet recruiting
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital | Southampton, SO16 6YD, United Kingdom Recruiting
Torbay Hospital | Torquay, TQ2 7AA, United Kingdom Recruiting
Расположение Страны

Argentina

Australia

Belarus

Belgium

Bosnia and Herzegovina

Bulgaria

Canada

Croatia

Czechia

Denmark

Finland

France

Germany

Ireland

Israel

Italy

Korea, Republic of

Latvia

Mexico

Moldova, Republic of

Norway

Poland

Romania

Russian Federation

Saudi Arabia

Spain

Switzerland

Taiwan

Turkey

Ukraine

United Kingdom

United States

Дата проверки

2021-11-01

Ответственная сторона

Тип: Спонсор

Ключевые слова
  • Crohn's Disease
  • Болезнь Крона
  • Устный
  • Озанимод
  • Умеренно активный
  • Очень активный
  • RPC01
  • RPC01-3201
Имеет расширенный доступ Нет
Количество рук 2
Группа вооружений

Метка: Administration of oral Ozanimod

Тип: Experimental

Метка: Введение плацебо

Тип: Компаратор плацебо

Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

Маскировка: Четырехместный (участник, поставщик медицинских услуг, исследователь, оценщик результатов)