Индукционное исследование № 2 перорального приема озанимода в категории условной терапии болезни Крона от умеренной до широкой активности

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 для изучения эффекта перорального озанимода в качестве участника лечения для участников с болезнью Крона от умеренной до степени тяжести.

Общий статус Рекрутинг
Дата начала 2018-03-07
Дата завершения 2023-07-10
Дата первичного завершения 2023-04-11
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 со снижением балла по простой эндоскопической шкале болезни Крона (SES-CD) по сравнению с исходным уровнем на ≥ 50% Неделя 12
Доля участников со снижением CDAI по сравнению с исходным уровнем на ≥ 100 баллов или показателем CDAI < 150 Неделя 12
Criterios de inclusión: - Haber firmado un documento de consentimiento informado indicando que los sujetos comprenden la propósito y procedimientos requeridos para el estudio y están dispuestos a participar en el estudio - Autorización por escrito para el uso y divulgación de información de estudios de investigación y salud ha sido obtenido - Estar dispuesto / ser capaz de adherirse a las prohibiciones y restricciones especificadas en este protocolo - Capaz de tragar el fármaco del estudio entero como un comprimido. - Dispuesto a tomar acetato de abiraterona con el estómago vacío; no se deben consumir alimentos en al menos dos horas antes y durante al menos una hora después de la dosis de acetato de abiraterona se toma - Los pacientes que tienen parejas en edad fértil deben estar dispuestos a utilizar un método. de control de la natalidad con una barrera de protección adecuada según lo determinado como aceptable por el investigador principal y el patrocinador durante el estudio y durante 1 semana después de la última dosis de acetato de abiraterona - Adenocarcinoma de próstata histológicamente probado - Estado funcional del Eastern Cooperative Oncology Group (ECOG) = <2 - Cáncer de próstata metastásico resistente a la castración definido por testosterona sérica <50 ng / ml y uno de los siguientes: - Nivel de antígeno prostático específico (PSA) de al menos 2 ng / ml que ha aumentado a al menos 2 ocasiones sucesivas con al menos 1 semana de diferencia - Progresión evaluable de la enfermedad mediante RECIST modificado (Criterios de evaluación de respuesta en Tumores sólidos) - Progresión de la enfermedad ósea metastásica en la gammagrafía ósea con> 2 nuevas lesiones - Mantenimiento de Lupron o antagonista a menos que haya sido tratado previamente con orquiectomía - La presencia de enfermedad metastásica susceptible de tomografía computarizada (TC) o ecografía. biopsia guiada; esto puede incluir cuerpos vertebrales toracolumbares, pelvis, fémur o húmero, tejidos blandos o metástasis ganglionares susceptibles de biopsia (excluyendo pulmón o lesiones pleurales) - Los pacientes pueden haber recibido manipulaciones hormonales secundarias (excluyendo acetato de abiraterona, MDV3100 o TAK700) o hasta dos líneas de quimioterapia; todo previo tratamiento, excepto que Lupron debe haberse interrumpido durante más de 4 semanas antes inscripción - Potasio sérico> = 3,5 mEq / L - Aspartato aminotransferasa (AST), alanina aminotransferasa (ALT) <1,5 x límite superior de normal (ULN) - Niveles de bilirrubina <1,5 x LSN - Albúmina sérica> = 3,0 g / dL - Bilirrubina total = <1,5 x LSN - Aclaramiento de creatinina calculado> = 60 ml / min - Recuento de plaquetas> = 100.000 / uL - Recuento absoluto de neutrófilos> 1500 células / mm ^ 3 - Hemoglobina> = 9,0 g / dL Criterio de exclusión: - Infección activa u otra afección médica que produciría prednisona / prednisolona (corticosteroide) uso contraindicado - Pacientes que actualmente están recibiendo terapia activa para otros trastornos neoplásicos. no será elegible - Los pacientes con evidencia histológica de carcinoma de células pequeñas de próstata no serán elegible - Metástasis cerebral conocida - Hipertensión no controlada (presión arterial sistólica [PA]> = 160 mmHg o PA diastólica> = 95 mmHg); Se permite a los pacientes con antecedentes de hipertensión siempre que tengan presión arterial. está controlado por tratamiento antihipertensivo - Hepatitis viral activa o sintomática o enfermedad hepática crónica. - Historia de disfunción pituitaria o suprarrenal - Enfermedad cardíaca clínicamente significativa evidenciada por infarto de miocardio, o Eventos trombóticos arteriales en los últimos 6 meses, angina severa o inestable, o Nueva Enfermedad cardíaca de clase II-IV de la York Heart Association (NYHA) o fracción de eyección cardíaca medición de <50% al inicio - Fibrilación auricular u otra arritmia cardíaca que requiera tratamiento médico. - Administración de un tratamiento en investigación dentro de los 30 días posteriores al cribado - Pacientes con demencia / enfermedad psiquiátrica / situaciones sociales que limitarían cumplimiento de los requisitos del estudio o prohibiría la comprensión y / o dar de consentimiento informado no será elegible - Pacientes con alguna patología que, a juicio del investigador, comprometa el bienestar del sujeto o el estudio o evitar que el sujeto se reúna o realizar los requisitos del estudio - Pacientes que requieran anticoagulación terapéutica (p. Ej., Warfarina, dabigatrán, heparina, o heparinas de bajo peso molecular [Lovenox, dalteparin]) - Pacientes con diabetes mal controlada - Pacientes con antecedentes de trastornos gastrointestinales (trastornos médicos o extensos cirugía) que pueden interferir con la absorción de los agentes del estudio - Pacientes con una enfermedad preexistente que justifique el uso de corticosteroides a largo plazo en exceso de la dosis del estudio - Pacientes con alergias conocidas, hipersensibilidad o intolerancia al acetato de abiraterona. o prednisona o sus excipientes - Insuficiencia hepática Child-Pugh clase B o C . Неделя 12
Доля участников с оценкой CDAI < 150 со снижением SES-CD по сравнению с исходным уровнем на ≥ 50% Неделя 12
Доля участников со средней дневной оценкой боли в животе ≤ 1 балла и средней дневной оценкой частоты стула ≤ 3 баллов, не хуже исходного уровня И SES-CD ≤ 4 баллов и снижением ≥ 2 баллов Неделя 12
Доля участников со средней дневной оценкой боли в животе ≤ 1 балла и средней дневной оценкой частоты стула ≤ 3 баллов, не хуже исходного уровня И снижением SES-CD по сравнению с исходным уровнем на ≥ 50% Неделя 12
Гистологическое улучшение, основанное на различиях между озанимодом и плацебо в показателях гистологической активности заболевания с использованием шкалы глобальной гистологической активности заболевания Неделя 12
Доля участников со снижением CDAI по сравнению с исходным уровнем ≥ 70 баллов Неделя 12
Доля участников с отсутствием язв ≥ 0,5 см без сегментов с какой-либо 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 области дни

Этикетка Arm Group: Администрация Плацебо

Приемлемость

Критерии:

Для получения дополнительной информации об исторических испытаниях Bristol-Myers Squibb, пожалуйста, Посетите: www.BMSStudyConnect.com Критерии включения: - Болезнь Крона в течение ≥ 3 месяцев по данным эндоскопии и гистологического исследования - Неадекватный ответ или потеря ответа на кортикостероиды, иммуномодуляторы и/или биологическая терапия - активность Крона болезни (CDAI) ≥ 2 Index20 и ≤ 450 баллов - Среднесуточная частота стула ≥ 4 баллов и/или боль в животе ≥ 2 баллов - Простая эндоскопическая шкала болезни Крона (SES-CD) ≥ 6 баллов (или SES-CD ≥ 4 в участники с изолированным зараженным подвздошной кишкой) Критерии исключения: - Диагностика язвенного колита, неопределенного колита, радиационного колита или ишемического колит или стриктуры с престенозной дилатацией, требующие хирургического вмешательства. вмешательство - Обширная резекция тонкой кишки (> 100 см) или известный диагноз синдрома короткой кишки, или требует полного парентерального питания - Текущая стома, подвздошно-анальный анастомоз или свищ 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 sites directly. If there is no contact information,

Телефон: please email:

Расположение
Объект: Положение дел:
HonorHealth Research Institute | Scottsdale, Arizona, 85258, United States Recruiting
Kindred Medical Institute for Clinical Trials, LLC | Corona, California, 92879, United States Not yet recruiting
UCSD Medical Center | La Jolla, California, 92037, United States Recruiting
OM Research | Lancaster, California, 93534, 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
Facey Medical Foundation (Parent) | Mission Hills, California, 91345, United States Completed
Havana Research Institute LLC | Pasadena, California, 91105, United States Completed
Sutter Medical Group | Roseville, California, 95661, United States Completed
UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit | Sacramento, California, 95817, 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
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
SIH Research | Kissimmee, Florida, 34759, 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
Life Medical Center & Research, Inc. | Miami, Florida, 33166, United States Recruiting
Vista Health Research | Miami, Florida, 33176, United States Recruiting
Bayside Clinical Research | New Port Richey, Florida, 34655, United States Recruiting
Omega Research Maitland, LLC | Orlando, Florida, 32810, United States Recruiting
IMIC, Inc. | Palmetto Bay, Florida, 33157, United States Recruiting
Theia Clinical Research, LLC | Pinellas Park, Florida, 33781, United States Completed
Precision Clinical Research, LLC. | Sunrise, Florida, 33351, United States Completed
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
Children's Healthcare of Atlanta | Atlanta, Georgia, 30322, United States Not yet recruiting
Emory Clinic | Atlanta, Georgia, 30322, United States Recruiting
Atlanta Center For Gastroenterology, P.C. | Decatur, Georgia, 30030, United States Recruiting
Grand Teton Research Group, PLLC | Idaho Falls, Idaho, 83404, United States Recruiting
University of Chicago | Chicago, Illinois, 60637, United States Recruiting
MediSphere Medical Research Center, LLC | Evansville, Indiana, 47714, United States Recruiting
Indiana University | Indianapolis, Indiana, 46202, United States Recruiting
Cotton ONeil Clinical Research Center Digestive Health | Topeka, Kansas, 66606, United States Recruiting
Gastroenterology Associates, LLC | Baton Rouge, Louisiana, 70809, 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
Harvard Medical School - Boston Children's Hospital | Boston, Massachusetts, 02115, United States Not yet recruiting
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts, 01655, 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
University of Minnesota Medical Center | Minneapolis, Minnesota, 55455, United States Recruiting
Mayo Clinic | Rochester, Minnesota, 55905, United States Recruiting
Mid America Gastrointestinal Consultants | Kansas City, Missouri, 64111, United States Recruiting
Internal Medicine Specialists | Las Vegas, Nevada, 89145, United States Completed
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire, 03756, 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
TrialSpark | New York, New York, 10024, United States Completed
DiGiovanna Institute for Medical Education And Research | North Massapequa, New York, 11758-1802, United States Recruiting
PMG Research of Charlotte LLC | Charlotte, North Carolina, 28209, United States Recruiting
PMG Research of Winston-Salem LLC | Winston-Salem, North Carolina, 27103, United States Recruiting
University Hospitals of Cleveland | Cleveland, Ohio, 44106-5000, United States Not yet 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
Paramount Medical Research & Consulting, LLC | Middleburg Heights, Ohio, 44130, United States Completed
Cancer Care Associates of OK-N PorterAvenue | Norman, Oklahoma, 73071, 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
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania, 19104, United States Recruiting
San Antonio Military Medical Center | Fort Sam Houston, Texas, 78234, United States Recruiting
Centex Studies, Inc. | Houston, Texas, 77058, United States Active, not recruiting
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
San Antonio Gastroenterology | San Antonio, Texas, 78229, United States Recruiting
Baylor Scott and White Health | Temple, Texas, 76508, United States Recruiting
Blue Ridge Medical Research | Lynchburg, Virginia, 24502, United States Recruiting
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
Franciscan Skemp Healthcare | La Crosse, Wisconsin, 54601, United States 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
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
Flinders Medical Centre | Bedford Park, South Australia, 5042, Australia Recruiting
Monash Medical Centre | Clayton, Victoria, 3168, Australia Recruiting
St Vincent's Hospital Melbourne | Fitzroy, Victoria, 3065, Australia Recruiting
St John of God Subiaco Hospital | Subiaco, Western Australia, 6008, Australia Completed
Medical University Innsbruck | Innsbruck, 6020, Austria Recruiting
University Hospital St. Poelten | St Polten, 3100, Austria Recruiting
Medical University Vienna | Vienna, 1090, Austria Recruiting
MHAT Ruse AD | Ruse, 7002, Bulgaria Recruiting
Excelsior Medical Center | Sofia, 1407, Bulgaria Recruiting
Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia | Sofia, 1407, Bulgaria Recruiting
Diagnostic and Consulting Center Alexandrovska | Sofia, 1431, Bulgaria Recruiting
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD | Sofia, 1527, Bulgaria Recruiting
West Edmonton Gastroenterology Consultants | Edmonton, Alberta, T5R1W2, Canada Recruiting
Fraser Clinical Trials Inc. | New Westminister, British Columbia, V3L 3W5, Canada Recruiting
GI Research Institute | Vancouver, British Columbia, V6Z 2K5, Canada Recruiting
Brandon Medical Arts Clinic | Brandon, Manitoba, R7A 0N7, Canada Recruiting
IWK Health Center | Halifax, Nova Scotia, B3K 6R8, Canada Not yet recruiting
Dr.Garisa Jagan Mohan Reddy MD | Sudbury, Ontario, P3C 5K6, Canada Completed
Mount Sinai Hospital | Toronto, Ontario, M5G 1X5, Canada Recruiting
Kensington Screening Clinic | Toronto, Ontario, M5T 3A9, Canada Recruiting
Hopital Maisonneuve-Rosemont | Montreal, Quebec, H1T 2M4, Canada Completed
The Ottawa Hospital - General Campus | Ottawa, Quebec, K1H 8L6, Canada Recruiting
Peking University First Hospital | Beijing, 100034, China Not yet recruiting
Peking University People's Hospital | Beijing, 100044, China Not yet recruiting
Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University | Beijing, 100050, China Not yet recruiting
The Seventh Medical Center of PLA General Hospital | Beijing, 100700, China Not yet recruiting
First Hospital of Jilin University | Changchun, 130021, China Not yet recruiting
Guangzhou First People's Hospital | Guangzhou Shi, 510180, China Not yet recruiting
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University | Hangzhou, Zhejiang, 100142, China Not yet recruiting
Anhui Provincial Hospital | Hefei, 230001, China Not yet recruiting
The First Affiliated Hospital of Nanchang University | Nanchang, 330006, China Not yet recruiting
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University | Nanjing, 210029, China Not yet recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai, 200127, China Not yet recruiting
China Medical University Hospital | Taichung City, 40447, China Recruiting
Wuhan Union Hospital | Wuhan, 430022, China Not yet recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Wuhan, 430030, China Not yet recruiting
Zhangzhou Municipal Hospital of Fujian Province | Zhangzhou, 363000, China Not yet recruiting
The Second Affiliated Hospital Of Zhengzhou University | Zhengzhou, 450014, China Not yet recruiting
Helsinki University Central Hospital (HUCH) | Helsinki, 00290, Finland Recruiting
Centre Hospitalier de Blois | Blois Cedex, 41016, France Recruiting
Beziers Hospital | Béziers, 34525, France Recruiting
University Hospital Center Caen | Caen, 14000, France Recruiting
Assistance Publique - Hopitaux de Paris - Hopital Beaujon | Clichy, 92118, France Recruiting
Louis Mourier Hospital | Colombes, 92701, France Recruiting
CHU Nantes University Hospital - Hotel Dieu Hospital | Nantes, 44093, France Recruiting
South Lyon Hospital Center | Pierre-Benite, 69495, France Recruiting
Saint-Etienne University Hospital Center | Saint Priest en Jarez, 42270, France Recruiting
JSC Evex Medical Corporation - Batumi Referral Hospital | Batumi, 6010, Georgia Recruiting
JSC Evex Medical Corporation - Oncology Center | Kutaisi, 4600, Georgia Recruiting
Helsicore - Israeli Georgian Medical Research Clinic | Tbilisi, 0112, Georgia Recruiting
LLC Vivamedi | Tbilisi, 0131, Georgia Recruiting
Tbilisi State Medical University | Tbilisi, 0141, Georgia Not yet recruiting
LTD Institute of Clinical Cardiology | Tbilisi, 0159, Georgia Recruiting
JSC Infectious Disease, AIDS and Clinical Immunology Research Center | Tbilisi, 0160, Georgia Recruiting
LTD Academician N.Kipshidze Central University Clinic | Tbilisi, 0160, Georgia Recruiting
LTD Aversi Clinic | Tbilisi, 0160, Georgia Recruiting
LTD MediClub Georgia | Tbilisi, 0160, Georgia Recruiting
David Tatishvili Medical Center | Tbilisi, 0186, Georgia Recruiting
JSC Evex Medical Corporation - Telavi Referral Hospital | Telavi, 2200, Georgia Recruiting
Gastroenterological Special Practice at Wittenbergplatz | Berlin, 10787, Germany Recruiting
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin, 12200, Germany Recruiting
Charite - Universitätsmedizin Berlin | Berlin, 13353, Germany Recruiting
Hospital Waldfriede e.V. | Berlin, 14163, Germany Recruiting
Brandenburg City Hospital | Brandenburg an der Havel, 14770, Germany Recruiting
Medical Care Unit Dachau | Dachau, 85221, Germany Recruiting
Klinikum Darmstadt | Darmstadt, 64283, Germany Not yet recruiting
Kliniken Essen-Mitte | Essen, 45136, Germany Not yet recruiting
Johann Wolfgang Goethe University Hospital | Frankfurt am Main, 60590, Germany Recruiting
Studiengesellschaft BSF | Halle, 06108, Germany Recruiting
University Hospital Halle (Saale) | Halle, 06120, Germany Recruiting
Asklepios Klinik Hamburg | Hamburg, 22559, Germany Completed
Universitatsklinikum Schleswig-Holstein | Keil, 24105, Germany Recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz, 55131, Germany Recruiting
University Hospital Muenster | Muenster, 48149, Germany Recruiting
Universitaetsklinikum Charite - Ruppiner Kliniken GmbH | Neuruppin, 16816, Germany Not yet recruiting
Robert-Bosch-Hospital | Stuttgart, 70376, Germany Recruiting
Laiko General Hospital of Athens | Athens, 11 527, Greece Completed
Sotiria Chest Diseases Hospital of Athens | Athens, 11527, Greece Completed
Tzanio General Hospital of Piraeus | Athens, 18536, Greece Completed
PAGNI University Hospital | Heraklion, 71 110, Greece Completed
General Hospital of Thessaloniki Hippokration | Thessaloniki, 54642, Greece Recruiting
424th Army General Hospital | Thessaloniki, 56429, Greece Recruiting
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz | Bekescsaba, 5600, Hungary Recruiting
Magyar Honvedseg Egeszsegugyi Kozpont | Budapest, 1062, Hungary Recruiting
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar | Budapest, 1088, Hungary Recruiting
Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat | Gyor, 9024, Hungary Recruiting
CRU Hungary Kft | Miskolc, 3529, Hungary Recruiting
Kanizsai Dorottya Hospital | Nagykanizsa, H-8800, Hungary Recruiting
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Szekesfehervar, 8000, Hungary Recruiting
Clinfan Ltd | Szekszárd, 7100, Hungary Recruiting
Csongrad County Dr. Bugyi Istvan Hospital | Szentes, 6600, Hungary Recruiting
Zala Megyei KorhazHaematologia | Zalaegerszeg, 8900, Hungary Not yet recruiting
Institute of Gastroenterology and Hepatology at Ha'Emek Medical Center | Afula, 18341, Israel Recruiting
Asaf Harofeh Medical Center | Beer Jacob, 73100, Israel Completed
Rambam Health Care Campus | Haifa, 3109601, Israel Recruiting
Clalit Health Services | Jerusalem, 9362410, Israel Completed
Meir Medical Center | Kfar-Saba, 44281, Israel Recruiting
Rabin Medical Center | Petah Tikva, 49100, Israel Recruiting
Tel-Aviv Sourasky Medical Center | Tel-Aviv, 64239, Israel Recruiting
Pusan National University Hospital | Busan, 49241, Korea, Republic of Recruiting
Inje University Haeundae Paik Hospital | Busan, 612-030, Korea, Republic of Recruiting
Yeungnam University Medical Center | Daegu, 705-030, Korea, Republic of Recruiting
Seoul National University Hospital | Seoul, 3080, Korea, Republic of Recruiting
St. Vincent's Hospital | Suwon, 442723, Korea, Republic of Recruiting
Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas, LT-50009, Lithuania Recruiting
Klaipeda University Hospital | Klaipeda, LT-5808, Lithuania Recruiting
Vilnius University Hospital Santariskes Clinics | Vilnius, 08406, Lithuania Completed
Vilnius University Hospital Santariskiu Klinikos | Vilnius, LT-08661, Lithuania Recruiting
Vilnius City Clinical Hospital | Vilnius, LT-10207, Lithuania Completed
Vrije Universiteit Medisch Centrum (VUMC) | Amsterdam, 1081 HV, Netherlands Recruiting
Academisch Medisch Centrum | Amsterdam, 1105 AZ, Netherlands Recruiting
UMC Groningen | Groningen, 9713 GZ, Netherlands Recruiting
Radboud University Medical Center | Nijmegen, 6525 GA, Netherlands Recruiting
Zuyderland Medisch Centrum | Sittard-Geleen, 6162 BG, Netherlands Recruiting
St. Elisabeth Ziekenhuis | Tilburg, 5022 GC, Netherlands Recruiting
St. John Paul 2nd Municipal Hospital in Elblag | Elblag, 82-300, Poland Recruiting
Nicolaus Copernicus Hospital | Gdansk, 80-803, Poland Recruiting
Private Medical Practice Miroslaw Fic | Jelenia Gora, 58-500, Poland Recruiting
BioVirtus Medical Centre | Jozefow, 05-410, Poland Recruiting
Centrum Opieki Zdrowotnej Orkan Med | Ksawerow, 95-054, Poland Recruiting
LUX MED Centrum Medyczne - Lodz | Lodz, 93-034, Poland Completed
Polish Mother's Memorial Hospital - Research Institute | Lodz, 93-338, Poland Not yet recruiting
Non-Public Healthcare Facility Allmedica Clinical Trials | Nowy Targ, 34-400, Poland Recruiting
Office of Bartosz Korczowski, MD | Rzeszow, 35-302, Poland Recruiting
Endoskopia Sp. z o.o. | Sopot, 81-756, Poland Recruiting
TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC | Szczecin, 71-270, Poland Recruiting
WIP Warsaw IBD Point | Warsaw, 00-728, Poland Recruiting
PRIMA LCC Specialist Clinics | Warsaw, 02-018, Poland Recruiting
Children's Memorial Health Institute | Warsaw, 04-730, Poland Recruiting
Endoterapia PFG LLC, Endotherapy PFG Outpatient Clinic Branch No 1 | Warszawa, 02-653, Poland Completed
Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice | Wierzchoslawice, 33-122, Poland Recruiting
LUX MED Centrum Medyczne - Wroclaw | Wroclaw, 50-053, Poland Recruiting
Wroclaw Medical University | Wroclaw, 50-367, Poland Recruiting
Jan Mikulicz Radecki University Hospital | Wroclaw, 50-369, Poland Not yet recruiting
Clinical Research Center Early-Phase Research Facility | Wroclaw, 51-162, Poland Recruiting
LexMedica | Wroclaw, 53-114, Poland Recruiting
Ars Medica | Wroclaw, 53-333, Poland Recruiting
EMC Medical Institute S.A | Wroclaw, 54-144, Poland Recruiting
Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra | Coimbra, 3000-075, Portugal Recruiting
Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes | Guimaraes, 4835-044, Portugal Recruiting
Hospital Beatriz Angelo | Loures, 2674-514, Portugal Recruiting
Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE | Viana do Castelo, 4904-858, Portugal Recruiting
Joint Venture Company Diagnostic Center, Bioterm Ltd. | Barnaul, 656015, Russian Federation Recruiting
Territorial Clinical Hospital | Barnaul, 656024, Russian Federation Recruiting
Regional Clinical Hospital #3 | Chelyabinsk, 454021, Russian Federation Completed
Chelyabinsk Regional Clinical Hospital | Chelyabinsk, 454076, Russian Federation Recruiting
Ural State Medical Academy - Medical Association Novaya Bolnitsa | Ekaterinburg, 620109, Russian Federation Recruiting
Immanuel Kant Baltic Federal University | Kaliningrad, 236016, Russian Federation Recruiting
Kaluga Regional Hospital | Kaluga, 248007, Russian Federation Completed
S.V. Beliaev Kemerovo Regional Clinical Hospital | Kemerovo, 650066, Russian Federation Recruiting
City Clinical Hospital n.a. V.M. Buyanov | Moscow, 115516, Russian Federation Recruiting
City Clinical Hospital 24 | Moscow, 117997, Russian Federation Completed
CJSC Nasledniki | Moscow, 119192, Russian Federation Completed
A.N. Ryzhikh State Research Center for Coloproctology | Moscow, 123423, Russian Federation Completed
Railway Station Clinical Hospital | Nizhny Novgorod, 603140, Russian Federation Recruiting
Medical Center Sibnovomed LLC | Novosibirsk, 630091, Russian Federation Recruiting
Scientific Research Institute of Physiology and Basic Medicine | Novosibirsk, 630117, Russian Federation Completed
Euromed Multi-Specialty Center for Contemporary Medicine LLC | Omsk, 644024, Russian Federation Completed
Medical Diagnostic Center LLC | Orenburg, 460050, Russian Federation Recruiting
N.N. Burdenko Penza Regional Clinical Hospital | Penza, 440026, Russian Federation Not yet recruiting
City Clinical Hospital No 31 - St. Petersburg | Saint Petersburg, 197110, Russian Federation Recruiting
S.M. Kirov Military Medical Academy | Saint-Petersburg, 194044, Russian Federation Recruiting
Medical University REAVIZ | Samara, 443001, Russian Federation Recruiting
Regional Clinical Hospital | Saratov, 410053, Russian Federation Recruiting
Sochi City Hospital No 5 | Sochi, 354207, Russian Federation Recruiting
Oncology Center of Moskovskiy District | St Petersburg, 196247, Russian Federation Recruiting
City Outpatient Care Unit No 38 | St. Petersburg, 191015, Russian Federation Recruiting
I.I. Mechnikov North-Western State Medical University | St. Petersburg, 191015, Russian Federation Recruiting
State Unitary Enterprise Passengeravtotrans | St. Petersburg, 195009, Russian Federation Recruiting
Medical Center Eko-Bezopasnost LLC | St. Petersburg, 196143, Russian Federation Recruiting
Tomsk Regional Clinical Hospital | Tomsk, 634063, Russian Federation Recruiting
G.G. Kuvatov Republican Clinical Hospital | Ufa, 450005, Russian Federation Recruiting
Medical Scientific Manufacturing Association Dvizheniye Clinic | Volgograd, 400107, Russian Federation Recruiting
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine | Belgrade, 11 080, Serbia Recruiting
Clinical Hospital Center - Dr. Dragisa Misovic-Dedinje | Belgrade, 11000, Serbia Not yet recruiting
Clinical Hospital Center Zvezdara Clinic of Internal Diseases | Belgrade, 11000, Serbia Recruiting
Military Medical Academy, Clinic of Gastroenterology and Hepatology | Belgrade, 11000, Serbia Recruiting
Clinical Center Kragujevac | Kragujevac, 34000, Serbia Recruiting
Clinical Center of Vojvodina, Clinic of Gastroenterology and Hepatology | Novi Sad, 21 000, Serbia Completed
General Hospital Pancevo | Pancevo, 26000, Serbia Recruiting
General Hospital Djordje Jovanovic Zrenjanin | Zrenjanin, 23 000, Serbia Recruiting
Cliniq, s.r.o. | Bratislava, 820 07, Slovakia Recruiting
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov | Bratislava, 82606, Slovakia Recruiting
Brezno gastroenterology center s.r.o. | Brezno, 97701, Slovakia Completed
KM Management, spol. s r.o. | Nitra, 94901, Slovakia Completed
Gastromedic s.r.o. | Nove Zamky, 94002, Slovakia Recruiting
GASTRO I., s.r.o. | Presov, 080 01, Slovakia Recruiting
World of the Health Inc. General Hospital Rimavska Sobota | Rimavska Sobota, 979 01, Slovakia Recruiting
General Hospital Celje | Celje, 3000, Slovenia Recruiting
Ahmed Kathrada Private Hospital | Gauteng, 1820, South Africa Recruiting
Emmed Research | Pretoria, 0084, South Africa Recruiting
Teknon Medical Center | Barcelona, 08022, Spain Recruiting
University Hospital Reina Sofia | Cordoba, 14001, Spain Recruiting
University Hospital of Girona Dr. Josep Trueta | Girona, 17007, Spain Recruiting
Hospital Universitario de Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria, 35012, Spain Recruiting
Hospital Clinico San Carlos | Madrid, 28040, Spain Recruiting
University Hospital Puerta de Hierro Majadajonda | Majadahonda, Madrid, 28222, Spain Recruiting
University Hospital Marques de Valdecilla (HUMV) | Santander, 39008, Spain Recruiting
University Clinical Hospital of Valencia | Valencia, 46010, Spain Recruiting
University Hospital Miguel Servet | Zaragoza, 50009, Spain Not yet recruiting
Saint Goran Hospital | Stockholm, 112 81, Sweden Completed
Ersta Hospital | Stockholm, 116 91, Sweden Not yet recruiting
Kaohsiung Medical University Hospital | Kaohsiung, San Ming Dist., 807, Taiwan Recruiting
E-DA Hospital | Kaohsiung, 82445, Taiwan Completed
Chang Gung Medical Foundation, Kaohsiung Memorial Hospital | Niao-Sung Hsiang Kaohsiung County, 83301, Taiwan Completed
National Cheng Kung University Hospital | Tainan, Taiana, 704, Taiwan Recruiting
Chang Gung Memorial Hospital- Linkou | Taoyuan City, 33305, Taiwan Recruiting
Taipei Veterans General Hospital | Tapei, Beitou Dist., 11217, Taiwan Completed
National Taiwan University Hospital | Tapei, 10002, Taiwan Recruiting
Hacettepe Universitesi | Ankara, 01660, Turkey Recruiting
Firat University Medical Faculty | Elazig, 23119, Turkey Completed
Istanbul University Cerrahpasa Medical Faculty | Istanbul, 34098, Turkey Completed
Sultan Abdulhamid Han Egitim ve Arastirma Hastanesi | Istanbul, 34668, Turkey Recruiting
Istanbul Medeniyet Uni Goztepe Training&Res Hosp | Istanbul, 34854, Turkey Recruiting
Chernivtsi Regional Clinical Hospital | Chernivtsi, 58001, Ukraine Completed
Dnipropetrovsk II Mechnykov Regional Clinical Hospital Surgery Department 2 | Dnipropetrovsk, 49027, Ukraine Not yet recruiting
Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk, 76008, Ukraine Recruiting
Kharkiv City Clinical Hospital 2 | Kharkiv, 61037, Ukraine Recruiting
Khmelnytskyi Regional Hospital | Khmelnytskyi, 29000, Ukraine Recruiting
Medical and Diagnostic Center Acinus | Kropyvnytskyi, 25006, Ukraine Recruiting
Medical Center Medical Clinic Blagomed LLC | Kyiv, 01023, Ukraine Not yet recruiting
Kyiv City Clinical Hospital #18 | Kyiv, 01030, Ukraine Not yet recruiting
BIK-KYIV Ukrainian German Gastroenterology Center | Kyiv, 01601, Ukraine Recruiting
Kyiv Regional Clinical Hospital | Kyiv, 04107, Ukraine Recruiting
Volyn Regional Clinical Hospital | Lutsk, 43005, Ukraine Recruiting
Lviv Regional Clinical Hospital | Lviv, 79010, Ukraine Recruiting
Odesa Regional Clinical Hospital Regional Gastroenterology Center Surgery Department | Odesa, 65025, Ukraine Recruiting
Vinnytsia M.I. Pyrohov Regional Clinical Hospital | Vinnytsia, 21018, Ukraine Recruiting
Health Clinic, LLC | Vinnytsya, 21009, Ukraine Recruiting
Multidisciplinary Clinic of the St. Nicholas, LLC | Zaporizhia, 69063, Ukraine Not yet recruiting
Zaporizhzhya Regional | Zaporizhzhya, 69600, Ukraine Recruiting
Расположение Страны

Australia

Austria

Bulgaria

Canada

China

Finland

France

Georgia

Germany

Greece

Hungary

Israel

Korea, Republic of

Lithuania

Netherlands

Poland

Portugal

Russian Federation

Serbia

Slovakia

Slovenia

South Africa

Spain

Sweden

Taiwan

Turkey

Ukraine

United States

Дата проверки

2021-11-01

Ответственная сторона

Тип: Спонсор

Ключевые слова
  • Crohn's Disease
  • Болезнь Крона
  • Устный
  • Озанимод
  • Умеренно активный
  • Сильно активен
  • RPC01
  • RPC01-3202
Имеет расширенный доступ Нет
Количество рук 2
Группа вооружений

Метка: Administration of oral Ozanimod

Тип: Experimental

Метка: Администрация Плацебо

Тип: Плацебо-компаратор

Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

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