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An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

  • Clinicaltrials.gov identifier

    NCT03467958

  • Recruitment Status

    Recruiting

  • First Posted

    March 16, 2018

  • Last update posted

    February 15, 2021

Study Description

Brief summary:

This is a Phase 3, open-label, multicenter extension study to evaluate safety and efficacy of ozanimod in subjects with moderately to severely active Crohn's Disease.

  • Condition or Disease:Crohn Disease
  • Intervention/Treatment: Drug: Ozanimod
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 1200 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
  • Actual Study Start Date: August 2018
  • Estimated Primary Completion Date: June 2026
  • Estimated Study Completion Date: September 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Administration of oral Ozanimod
Subjects will receive a single 0.92 mg capsule [equivalent to ozanimod HCl 1 mg] once daily x 48 weeks
Drug: Ozanimod
Ozanimod

Outcome Measures

  • Primary Outcome Measures: 1. Proportion of subjects with a CDAI score of < 150 [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • Secondary Outcome Measures: 1. Proportion of subjects with a simple endoscopy score (SES-CD) decrease from baseline of ≥ 50% [ Time Frame: Up to 234 Weeks ]
    The SES-CD assesses the degree of inflammation.
  • 2. Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline [ Time Frame: Up to 234 Weeks ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary
  • 3. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • 4. Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Up to 234 Weeks ]
    Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.
  • 5. Proportion of subjects with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • 6. Change from baseline in CDAI [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • 7. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
  • 8. Proportion of subjects with CDAI score of < 150 and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
  • 9. Proportion of subjects with average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points [ Time Frame: Up to 234 Weeks ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.
  • 10. Proportion of subjects with SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points [ Time Frame: Up to 234 Weeks ]
    The SES-CD assesses the degree of inflammation.
  • 11. Proportion of subjects with a CDAI score < 150 in subjects off corticosteroids [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
  • 12. Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Up to 234 Weeks ]
    The CDEIS assesses the degree of endoscopic inflammation.
  • 13. Proportion of subjects with a PCDAI score of ≤ 10 points [ Time Frame: Up to 234 Weeks ]
    Pediatric Crohn's Disease Activity Index (PCDAI) is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991)

Eligibility Criteria

  • Ages Eligible for Study: 12 to 75 Years (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Subjects who are not in clinical response or clinical remission after completing 12 weeks in the Induction Studies RPC01-3201 or RPC01-3202, subjects who experience relapse or who complete the Maintenance Study RPC01-3203, and subjects who complete a study of ozanimod for Crohn's Disease and meet the criteria for participation in the RPC01-3204 Study will have the opportunity to participate in this study. 2. Must be male or female subjects aged 18 to 75 years (at Pre-baseline), inclusive. 3. Subject must provide written informed consent prior to any study-related procedures, and have the ability to comply with the Table of Events. 4. Female subjects of childbearing potential: Must agree to practice a highly effective method of contraception throughout the study until completion of the 75-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl Index of less than 1% per year when used consistently and correctly. Acceptable methods of birth control in the study are the following: - Combined hormonal (containing oestrogen and progestogen) contraception, which may be oral, intravaginal, or transdermal - Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable - Placement of an intrauterine device (IUD) - Placement of an intrauterine hormone-releasing system (IUS) - Bilateral tubal occlusion - Vasectomised partner - Sexual abstinence Male subjects: Must agree to use a latex condom during sexual contact with women of childbearing potential while participating in the study until completion of the 75-day Safety Follow-up Visit. All subjects: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together. Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: Exclusions Related to General Health: 1. Subject has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study Exclusions Related to Medications: Subject has received any of the following therapies since the first dose of IP in the prior ozanimod study: 1. treatment with a biologic agent as well as other treatments for CD such as etrasimod, filgotinib, upadacitinib 2. treatment with an investigational agent other than ozanimod 3. treatment with D-penicillamine, leflunomide, thalidomide, natalizumab, fingolimod or other S1P modulators 4. treatment with lymphocyte-depleting therapies (eg, Campath®, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab) Subject is currently receiving or requires initiation of any of the following therapies: 1. treatment with corticosteroids at a dose that exceeds the prednisone equivalent of >40 mg 2. treatment with immunomodulatory agents (eg, azathioprine, 6-MP, or methotrexate) Exclusions Related to Laboratory Results: Subject has any clinically significant abnormality ECG results which in the opinion of the investigator may put the subject at risk.

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations

Germany
DRK Clinics Berlin
Berlin

Germany
Charite - Universitaetsmedizin Berlin
Berlin

Germany
Gastroenterological Special Practice at Wittenbergplatz
Berlin

Germany
Gastroenterology Am Bayerischen Platz
Berlin

Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin

Germany
Charite - Universitätsmedizin Berlin
Berlin

Germany
Hospital Waldfriede e.V.
Berlin

Germany
Brandenburg City Hospital
Brandenburg an der Havel

Germany
Medical Care Unit Dachau
Dachau

Germany
Klinikum Darmstadt
Darmstadt

Germany
Kliniken Essen-Mitte
Essen

Germany
Johann Wolfgang Goethe University Hospital
Frankfurt am Main

Germany
Agaplesion Markus Krankenhaus
Frankfurt

Germany
Interdisciplinary Crohn Colitis Center Rhein Main
Frankfurt

Germany
Studiengesellschaft BSF
Halle

Germany
University Hospital Halle (Saale)
Halle

Germany
University Hospital Hamburg-Eppendorf
Hamburg

Germany
Asklepios Klinik Hamburg
Hamburg

Germany
Universitatsklinikum Schleswig-Holstein
Keil

Germany
Universitaetsklinikum Leipzig AoeR
Leipzig

Germany
Practice for Gastroenterology and Internal Medicine
Ludwigshafen am Rhein

Germany
St Marien und St Annastiftskrankenhaus
Ludwigshafen am Rhein

Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz

Germany
University Hospital Muenster
Muenster

Germany
Synesis Research Center
Munich

Germany
Universitaetsklinikum Charite - Ruppiner Kliniken GmbH
Neuruppin

Germany
Robert-Bosch-Hospital
Stuttgart

Germany
Universitaetsklinikum Tuebingen
Tuebingen

Germany
Universitaetsklinikum Ulm
Ulm

United States, Arizona
Holland Center for Family Health
Peoria

United States, Arizona
Elite Clinical Studies, LLC
Phoenix

United States, Arizona
HonorHealth Research Institute
Scottsdale

United States, Arkansas
Arkansas Gastroenterology, P.A.
North Little Rock

United States, California
Sharp Chula Vista Medical Center
Chula Vista

United States, California
Kindred Medical Institute for Clinical Trials, LLC
Corona

United States, California
Valley View Internal Medicine
Garden Grove

United States, California
UCSD Medical Center
La Jolla

United States, California
San Diego Clinical Trials
La Mesa

United States, California
OM Research
Lancaster

United States, California
Children's Hospital of Los Angeles
Los Angeles

United States, California
Southern California Research Institute Medical Group, Inc.
Los Angeles

United States, California
Matrix Clinical Research Inc
Los Angeles

United States, California
Gastrointestinal Biosciences
Los Angeles

United States, California
VA Northern California Health Care System
Mather

United States, California
Facey Medical Foundation (Parent)
Mission Hills

United States, California
ABS Health, LLC
Mission Viejo

United States, California
Alliance Clinical Research
Oceanside

United States, California
Palo Alto Center-Palo Alto Medical Foundation Research Institute
Palo Alto

United States, California
Havana Research Institute LLC
Pasadena

United States, California
Inland Empire Liver Foundation
Rialto

United States, California
Sutter Medical Group
Roseville

United States, California
UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit
Sacramento

United States, California
Medical Associates Research Group
San Diego

United States, California
University of California at San Francisco
San Francisco

United States, California
New Hope Research Development
West Covina

United States, Colorado
Peak Gastroenterology Associates
Colorado Springs

United States, Connecticut
Connecticut Clinical Research Foundation
Bristol

United States, Connecticut
Yale University
New Haven

United States, Florida
Gastro Florida
Clearwater

United States, Florida
Clinical Research of West Florida
Clearwater

United States, Florida
South Lake Pain Institute
Clermont

United States, Florida
American Research Institute Inc
Cutler Bay

United States, Florida
Universal Axon Clinical Research
Doral

United States, Florida
Riverside Clinical Research
Edgewater

United States, Florida
University of Florida Health Endocrinology - Medical Specialties - Medical Plaza
Gainesville

United States, Florida
Qway Research LLC
Hialeah

United States, Florida
Floridian Clinical Research LLC
Hialeah

United States, Florida
Harmony Medical Research Institute
Hialeah

United States, Florida
The Center for Gastrointestinal Disorders
Hollywood

United States, Florida
Vista Health Research
Homestead

United States, Florida
SIH Research
Kissimmee

United States, Florida
Florida Center for Gastroenterology
Largo

United States, Florida
Pioneer Clinical Research
Lighthouse Point

United States, Florida
Center For Advanced Gastroenterology
Maitland

United States, Florida
Galiz Research LLC
Miami Springs

United States, Florida
LMG Research
Miami

United States, Florida
Nova Clinical Research Center LLC
Miami

United States, Florida
LCC Medical Research Institute, LLC
Miami

United States, Florida
Research Associates of South Florida LLC
Miami

United States, Florida
Life Medical Center & Research, Inc.
Miami

United States, Florida
Vista Health Research
Miami

United States, Florida
Advanced Research for Health Improvement
Naples

United States, Florida
Bayside Clinical Research
New Port Richey

United States, Florida
NSB Research
New Smyrna Beach

United States, Florida
Omega Research Maitland, LLC
Orlando

United States, Florida
HMD Research LLC
Orlando

United States, Florida
IMIC, Inc.
Palmetto Bay

United States, Florida
Theia Clinical Research, LLC
Pinellas Park

United States, Florida
Advanced Medical Research Center
Port Orange

United States, Florida
Precision Clinical Research, LLC.
Sunrise

United States, Florida
University of South Florida
Tampa

United States, Florida
Apex Clinical Research
Tampa

United States, Florida
Guardian Angel Health Svcs Inc
Tampa

United States, Florida
Asclepes Research Centers
Weeki Wachee

United States, Georgia
Consultative Gastroenterology
Atlanta

United States, Georgia
Children's Healthcare of Atlanta
Atlanta

United States, Georgia
Emory Clinic
Atlanta

United States, Georgia
Atlanta Gastroenterology Associates, LLC
Atlanta

United States, Georgia
Children's Center for Digestive Healthcare
Atlanta

United States, Georgia
Gastrointestinal Disease Research
Columbus

United States, Georgia
Atlanta Center For Gastroenterology, P.C.
Decatur

United States, Georgia
Gastroenterology Associates Of Central Georgia LLC
Macon

United States, Idaho
Grand Teton Research Group, PLLC
Idaho Falls

United States, Illinois
Rush University Medical Center - University Cardiovascular Surgeons
Chicago

United States, Illinois
Northwestern University
Chicago

United States, Illinois
University of Chicago
Chicago

United States, Illinois
DM Clinical Research
Oak Lawn

United States, Illinois
Carle Foundation Hospital
Urbana

United States, Indiana
MediSphere Medical Research Center, LLC
Evansville

United States, Indiana
Indiana University
Indianapolis

United States, Iowa
Iowa Digestive Disease Center
Clive

United States, Kansas
Cotton ONeil Clinical Research Center Digestive Health
Topeka

United States, Kentucky
University of Kentucky Health Care
Lexington

United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge

United States, Louisiana
CroNOLA LLC
Houma

United States, Louisiana
Centex Studies, Inc.
Lake Charles

United States, Louisiana
Clinical Trials of SW Louisiana LLC
Lake Charles

United States, Louisiana
Tandem Clinical Research, LLC
Marrero

United States, Louisiana
Nola Research Works
New Orleans

United States, Louisiana
LSU Health Sciences Center Shreveport
Shreveport

United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore

United States, Maryland
Digestive Disease Associates, PA
Catonsville

United States, Maryland
Woodholme Gastroenterology Associates
Glen Burnie

United States, Massachusetts
Harvard Medical School - Boston Children's Hospital
Boston

United States, Massachusetts
Brigham and Women's Hospital - Crohn's and Colitis Center
Chestnut Hill

United States, Massachusetts
Baystate Medical Center
Springfield

United States, Massachusetts
University of Massachusetts Memorial Medical Center
Worcester

United States, Michigan
Medex Research Institute
Caro

United States, Michigan
Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo

United States, Michigan
Henry Ford Medical Center - New Center One
Novi

United States, Michigan
Revive Research Institute
Southfield

United States, Minnesota
University of Minnesota Medical Center
Minneapolis

United States, Minnesota
Mayo Clinic
Rochester

United States, Mississippi
Southern Therapy and Advanced Research
Jackson

United States, Missouri
Mid America Gastrointestinal Consultants
Kansas City

United States, Missouri
Washington University School of Medicine
Saint Louis

United States, Nevada
Internal Medicine Specialists
Las Vegas

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon

United States, New Jersey
Englewood Hospital and Medical Center
Englewood

United States, New Mexico
University of New Mexico Hospital
Albuquerque

United States, New York
Advantage Clinical Trials
Bronx

United States, New York
NY Scientific
Brooklyn

United States, New York
Adirondack Medical Research Center
Glens Falls

United States, New York
Northwell Health
Great Neck

United States, New York
Drug Trials America
Hartsdale

United States, New York
Weill Cornell Medical College
New York

United States, New York
Concorde Medical Group
New York

United States, New York
Cornell University
New York

United States, New York
TrialSpark
New York

United States, New York
Lenox Hill Hospital
New York

United States, New York
DiGiovanna Institute for Medical Education And Research
North Massapequa

United States, New York
Circuit Clinical
Orchard Park

United States, North Carolina
Asheville Gastroenterology Associates, P.A.
Asheville

United States, North Carolina
Carolinas HealthCare System Digestive Health
Charlotte

United States, North Carolina
Internal Medicine Research
Charlotte

United States, North Carolina
PMG Research of Charlotte LLC
Charlotte

United States, North Carolina
Carolina Research Center
Greenville

United States, North Carolina
PMG Research of Winston-Salem LLC
Winston-Salem

United States, Ohio
Great Lakes Medical Research, LLC
Beachwood

United States, Ohio
University Hospitals of Cleveland
Cleveland

United States, Ohio
Cleveland Clinic - Taussig Cancer Institute
Cleveland

United States, Ohio
Advance Clinical Research - Dayton Internal Medicine
Dayton

United States, Ohio
Ohio State University Wexner Medical Center
Hilliard

United States, Ohio
Great Lakes Gastroenterology
Mentor

United States, Ohio
Paramount Medical Research & Consulting, LLC
Middleburg Heights

United States, Ohio
Great Lakes Medical Research, LLC
Warren

United States, Oklahoma
Cancer Care Associates of OK-N PorterAvenue
Norman

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City

United States, Oklahoma
Digestive Disease Specialists
Oklahoma City

United States, Oklahoma
Allergy, Asthma and Immunology Center, PC
Tulsa

United States, Oklahoma
Central States Research, LLC
Tulsa

United States, Oregon
Oregon Health & Science University
Portland

United States, Pennsylvania
Penn State Milton S Hershey Medical Center
Hershey

United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia

United States, Pennsylvania
Penn State University Milton S Hershey Medical Center
State College

United States, South Carolina
Gastroenterology Associates of Orangeburg
Orangeburg

United States, Tennessee
Quality Medical Research
Nashville

United States, Tennessee
Vanderbilt University Medical Center
Nashville

United States, Tennessee
Advanced Gastroenterology
Union City

United States, Texas
Avant Research Associates, LLC - Austin
Austin

United States, Texas
San Antonio Military Medical Center
Fort Sam Houston

United States, Texas
Baylor College of Medicine
Houston

United States, Texas
Houston Methodist Hospital
Houston

United States, Texas
Biopharma Informatic Inc. Research Center
Houston

United States, Texas
Centex Studies, Inc.
Houston

United States, Texas
GI Specialists of Houston
Houston

United States, Texas
Premier Vein and Vascular Center
Houston

United States, Texas
The Coastal Medical Group
Houston

United States, Texas
Gulf Coast Research Group LLC
Houston

United States, Texas
Accurate Clinical Research Inc
Pasadena

United States, Texas
DHAT Research Institute
Richardson

United States, Texas
Sun Research Institute
San Antonio

United States, Texas
San Antonio Gastroenterology
San Antonio

United States, Texas
Texas Digestive Disease Consultants - Southlake
Southlake

United States, Texas
Baylor Scott and White Health
Temple

United States, Texas
Digestive Health Specialists of Tyler
Tyler

United States, Utah
University of Utah School of Medicine
Salt Lake City

United States, Virginia
Gastroenterology Associates, PC
Gainesville

United States, Virginia
Blue Ridge Medical Research
Lynchburg

United States, Virginia
Summit Clinical Research, LLC
Petersburg

United States, Virginia
The Gastroenterology Group
Reston

United States, Virginia
McGuire Veterans Affairs Medical Center
Richmond

United States, Virginia
Carilion Clinic
Roanoke

United States, Virginia
Virginia Gastroenterology Institute PC
Suffolk

United States, Washington
University of Washington Medical Center
Seattle

United States, Washington
Dermatologist Specialists of Spokane
Spokane

United States, Wisconsin
Aurora Health Care Aurora Research
Grafton

United States, Wisconsin
Franciscan Skemp Healthcare
La Crosse

Poland
SOLUMED Medical Center
Poznan

Poland
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bialystok

Poland
Medical Services Center MaxMed
Bochnia

Poland
St. John Paul 2nd Municipal Hospital in Elblag
Elblag

Poland
Nicolaus Copernicus Hospital
Gdansk

Poland
Private Medical Practice Miroslaw Fic
Jelenia Gora

Poland
BioVirtus Medical Centre
Jozefow

Poland
Nzoz All-Medicus
Katowice

Poland
Kornel Gibinski Independent Public Central Clinical Hospital in Katowice
Katowice

Poland
GLOBE Clinical Research Sp. z o.o. LLC
Klodzko

Poland
PLEJADY Sp. z o.o. (LLC) Medical Centre
Krakow

Poland
Landa Specialist Doctor's Offices
Krakow

Poland
Krakow Medical Center LLC
Krakow

Poland
Centrum Opieki Zdrowotnej Orkan Med
Ksawerow

Poland
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz

Poland
Salve Limited Liability Company Limited Partnership, Outpatient Clinic
Lodz

Poland
LUX MED Centrum Medyczne - Lodz
Lodz

Poland
Polish Mother's Memorial Hospital - Research Institute
Lodz

Poland
1 Military Clinical Hospital in Lublin
Lublin

Poland
Non-Public Healthcare Facility Allmedica Clinical Trials
Nowy Targ

Poland
Provincial Specialist Hospital in Olsztyn
Olsztyn

Poland
Office of Bartosz Korczowski, MD
Rzeszow

Poland
Endoskopia Sp. z o.o.
Sopot

Poland
TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC
Szczecin

Poland
GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe
Torun

Poland
H-T. Medical Center Sp. z o.o. LLC Limited Partnership
Tychy

Poland
Polimedica
Ul. Piotrkowska 177

Poland
Maternal Pediatric and Adolescent Healthcare Centre
Warsaw

Poland
WIP Warsaw IBD Point
Warsaw

Poland
PRIMA LCC Specialist Clinics
Warsaw

Poland
Children's Memorial Health Institute
Warsaw

Poland
Endoterapia PFG LLC, Endotherapy PFG Outpatient Clinic Branch No 1
Warszawa

Poland
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
Warszawa

Poland
Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice
Wierzchoslawice

Poland
LUX MED Centrum Medyczne - Wroclaw
Wroclaw

Poland
Wroclaw Medical University
Wroclaw

Poland
Jan Mikulicz Radecki University Hospital
Wroclaw

Poland
Clinical Research Center Early-Phase Research Facility
Wroclaw

Poland
LexMedica
Wroclaw

Poland
Ars Medica
Wroclaw

Poland
EMC Medical Institute S.A
Wroclaw

Argentina
Sanatorio Guemes
Ciudad Autonoma de Buenos Aires

Argentina
Hospital Privado Centro Medico de Cordoba
Cordoba

Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario

Argentina
Universidad Nacional De Rosario - Hospital Provincial Del Centenario
Rosario

Argentina
Sanatorio 9 de Julio - CICE 9 de Julio
San Miguel de Tucuman

Australia, New South Wales
Concord Repatriation General Hospital
Concord

Australia, New South Wales
Nepean Hospital
Kingswood

Australia, New South Wales
Liverpool Hospital
Liverpool

Australia, New South Wales
John Hunter Hospital and Hunter Medical Research Institute
New Lambton Heights

Australia, New South Wales
Wollongong Hospital
Wollongong

Australia, Queensland
Coastal Digestive Health
Maroorchydore

Australia, Queensland
University of the Sunshine Coast
North Mackay

Australia, Queensland
Mater Hospital Brisbane
South Brisbane

Australia, Queensland
Princess Alexandra Hospital
Woolloongabba

Australia, South Australia
Royal Adelaide Hospital
Adelaide

Australia, South Australia
Flinders Medical Centre
Bedford Park

Australia, South Australia
The Queen Elizabeth Hospital
Woodville South

Australia, Victoria
Monash Medical Centre
Clayton

Australia, Victoria
St Vincent's Hospital Melbourne
Fitzroy

Australia, Western Australia
Harry Perkins Medical Research Institute, Fiona Stanley Hospital
Murdoch

Australia, Western Australia
St John of God Subiaco Hospital
Subiaco

Australia
Ballarat Base Hospital
Ballarat

Austria
Medical University Innsbruck
Innsbruck

Austria
University Hospital St. Poelten
St Polten

Austria
Medical University Vienna
Vienna

Belarus
Grodno City Clinical Hospital #4
Grodno

Belarus
Vitebsk Regional Clinical Specialized Center
Vitebsk

Belgium
Algemeen Ziekenhuis Klina
Brasschaat

Belgium
Universitair Ziekenhuis Brussel
Brussels

Belgium
University Hospital Brussels
Brussels

Belgium
CHU Saint-Luc
Brussels

Belgium
Queen Fabiola Children's University Hospital
Brussels

Belgium
Universitair Ziehenhuis Antwerpen
Edegem

Belgium
Universitair Ziekenhuis Gent
Ghent

Belgium
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
Leuven

Belgium
Clinique du Montlegia
Liege

Belgium
Sart Tilman Hospital Department of Gastroenterology and Hepatology
Seraing

Belgium
Hospital Centre of Walloon Picarde
Tournai

Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska
Banja Luka

Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar

Bosnia and Herzegovina
Clinical Center University of Sarajevo
Sarajevo

Bosnia and Herzegovina
General Hospital "Prim.dr. Abdulah Nakas"
Sarajevo

Bulgaria
Multiprofile Hospital for Active Treatment Medline
Plovdiv

Bulgaria
MHAT Ruse AD
Ruse

Bulgaria
Second MHAT Sofia AD
Sofia

Bulgaria
Excelsior Medical Center
Sofia

Bulgaria
Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia
Sofia

Bulgaria
Diagnostic and Consulting Center Alexandrovska
Sofia

Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
Sofia

Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
Sofia

Bulgaria
Diagnostic-Consultative Center Sveta Anna
Sofia

Bulgaria
University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
Sofia

Bulgaria
ACIBADEM City Clinic Medical Center Bregalnitsa
Varna

Canada, Alberta
University of Calgary Health - The Gastrointestinal Research Group (GIRG)
Calgary

Canada, Alberta
West Edmonton Gastroenterology Consultants
Edmonton

Canada, British Columbia
Okanagan Clinical Trials Ltd
Kelowna

Canada, British Columbia
Fraser Clinical Trials Inc.
New Westminister

Canada, British Columbia
Vancouver Hospital Gastrointestinal Research Unit The Gordon and Leslie Diamond Centre
Vancouver

Canada, British Columbia
GI Research Institute
Vancouver

Canada, Manitoba
Brandon Medical Arts Clinic
Brandon

Canada, Manitoba
Winnipeg Clinic Dermatology Research
Winnipeg

Canada, Nova Scotia
Viable Clinical Research
Bridgewater

Canada, Nova Scotia
IWK Health Center
Halifax

Canada, Ontario
London Health Sciences Centre, University Hospital
London

Canada, Ontario
LHSC Victoria Hospital
London

Canada, Ontario
Dr.Garisa Jagan Mohan Reddy MD
Sudbury

Canada, Ontario
Mount Sinai Hospital
Toronto

Canada, Ontario
Kensington Screening Clinic
Toronto

Canada, Ontario
Toronto Digestive Disease Associates Inc
Vaughan

Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal

Canada, Quebec
The Ottawa Hospital - General Campus
Ottawa

China
Peking University First Hospital
Beijing

China
Peking University People's Hospital
Beijing

China
Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University
Beijing

China
The Seventh Medical Center of PLA General Hospital
Beijing

China
First Hospital of Jilin University
Changchun

China
Guangzhou First People's Hospital
Guangzhou Shi

China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang

China
Anhui Provincial Hospital
Hefei

China
The First Affiliated Hospital of Nanchang University
Nanchang

China
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Nanjing

China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai

China
China Medical University Hospital
Taichung City

China
Wuhan Union Hospital
Wuhan

China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan

China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou

China
The Second Affiliated Hospital Of Zhengzhou University
Zhengzhou

Croatia
Clinical Hospital Center Osijek
Osijek

Croatia
Clinical Hospital Centre Rijeka
Rijeka

Croatia
Clinical Hospital Center Split
Split

Croatia
Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases
Zagreb

Croatia
Clinical Hospital Dubrava
Zagreb

Croatia
University Hospital Centre Zagreb, Clinic of Internal Diseases
Zagreb

Czechia
Military Hospital Brno
Brno

Czechia
St. Anne's University Hospital Brno
Brno

Czechia
Hepato-Gastroenterologie HK, s. r. o.
Hradec Králové

Czechia
Soukroma Gastroenterologicka ambulance a endoskopie
Most

Czechia
PreventaMed
Olomouc

Czechia
Krajská nemocnice Pardubice, Kožní oddelení
Pardubice

Czechia
University Hospital Pilsen
Plzen

Czechia
University Hospital Motol
Prague 5

Czechia
ISCARE, a.s.
Prague 9

Czechia
Institut klinicke a experimentalni mediciny
Praha 4

Denmark
Bispebjerg Hospital
Copenhagen

Denmark
Holbaek Hospital
Holbaek

Denmark
Nykobing F Hospital
Nykobing F

Finland
Helsinki University Central Hospital (HUCH)
Helsinki

Finland
Turku University Hospital
Turku

France
CHU Amiens Picardie - Site Sud
Amiens cedex 1

France
Centre Hospitalier de Blois
Blois Cedex

France
Beziers Hospital
Béziers

France
University Hospital Center Caen
Caen

France
Assistance Publique - Hopitaux de Paris - Hopital Beaujon
Clichy

France
Louis Mourier Hospital
Colombes

France
Centre Hospitalier Intercommunal de Creteil
Creteil Cedex

France
CHU de Dijon Bourgogne - Hopital Francois Mitterand
Dijon Cedex

France
CHU de Grenoble Alpes
Grenoble Cedex 9

France
CHRU de Lille - Hopital Claude Huriez
Lillie Cedex

France
Hopital Nord
Marseille cedex 20

France
CHU Nantes University Hospital - Hotel Dieu Hospital
Nantes

France
South Lyon Hospital Center
Pierre-Benite

France
Hospital Pontchaillou
Rennes

France
CHU de Rouen Hopital Charles Nicolle
Rouen Cedex

France
Saint-Etienne University Hospital Center
Saint Priest en Jarez

France
CHU de Toulouse Hopital Rangueil
Toulouse Cedex 09

Georgia
JSC Evex Medical Corporation - Batumi Referral Hospital
Batumi

Georgia
JSC Evex Medical Corporation - Oncology Center
Kutaisi

Georgia
Helsicore - Israeli Georgian Medical Research Clinic
Tbilisi

Georgia
LLC Vivamedi
Tbilisi

Georgia
Tbilisi State Medical University
Tbilisi

Georgia
LTD Institute of Clinical Cardiology
Tbilisi

Georgia
JSC Infectious Disease, AIDS and Clinical Immunology Research Center
Tbilisi

Georgia
LTD Academician N.Kipshidze Central University Clinic
Tbilisi

Georgia
LTD Aversi Clinic
Tbilisi

Georgia
LTD MediClub Georgia
Tbilisi

Georgia
David Tatishvili Medical Center
Tbilisi

Georgia
JSC Evex Medical Corporation - Telavi Referral Hospital
Telavi

Greece
Laiko General Hospital of Athens
Athens

Greece
Sotiria Chest Diseases Hospital of Athens
Athens

Greece
Tzanio General Hospital of Piraeus
Athens

Greece
PAGNI University Hospital
Heraklion

Greece
General Hospital of Thessaloniki Hippokration
Thessaloniki

Greece
424th Army General Hospital
Thessaloniki

Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
Bekescsaba

Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest

Hungary
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar
Budapest

Hungary
Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat
Gyor

Hungary
CRU Hungary Kft
Miskolc

Hungary
Kanizsai Dorottya Hospital
Nagykanizsa

Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Szekesfehervar

Hungary
Clinfan Ltd
Szekszárd

Hungary
Csongrad County Dr. Bugyi Istvan Hospital
Szentes

Hungary
Zala Megyei KorhazHaematologia
Zalaegerszeg

Ireland, Dublin
St Vincent's University Hospital
Dublin 4

Ireland
Beaumont Hospital
Dublin 9

Israel
Institute of Gastroenterology and Hepatology at Ha'Emek Medical Center
Afula

Israel
Bat Yamon Medical Center, Clalit Medical Services
Bat Yam

Israel
Asaf Harofeh Medical Center
Beer Jacob

Israel
Rambam Health Care Campus
Haifa

Israel
Shaare Zedek Medical Center
Jerusalem

Israel
Clalit Health Services
Jerusalem

Israel
Meir Medical Center
Kfar-Saba

Israel
Galilee Medical Center
Nahariya

Israel
Rabin Medical Center
Petah Tikva

Israel
Chaim Sheba Medical Center
Ramat Gan

Israel
Kaplan Medical Center
Rechovot

Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv

Italy
University Polyclinic Hospital of Bari
Bari

Italy
Polyclinic S. Orsola-Malpighi
Bologna

Italy
Civil Hospital of Brescia
Brescia

Italy
Poliambulanza Hospital
Brescia

Italy
IRCCS "Savario De Bellis"
Castellana Grotte

Italy
University Hospital Mater Domini
Catanzaro

Italy
"Ss. Annunziata" Policlinic of Chieti
Chieti

Italy
University Polyclinic Hospital G. Martino
Messina

Italy
Maggiore Polyclinic Hospital, IRCCS Ca' Granda
Milano

Italy
Humanitas Research Hospital - Humanitas Mirasole S.p.A
Milan

Italy
Azienda Socio Sanitaria Territoriale (ASST) di Monza
Monza

Italy
Hospital of Di Padova
Padova

Italy
United Hospitals Villa Sofia Cervello
Palermo

Italy
Polyclinic San Matteo IRCCS
Pavia

Italy
Polyclinic Tor Vergata
Roma

Italy
Univerisity Polyclinic Foundation Agostino Gemelli
Roma

Italy
Azienda Ospedaliera San Camillo Forlanini
Rome

Italy
Integrated University Hospital Santa Maria della Misericordia of Udine
Udine

Italy
A.O. Universitaria Fondazione Macchi
Varese

Italy
Sacred Heart Don Calabria
Verona

Korea, Republic of
Korea University Medical Center - Korea University Ansan Hospital
Ansan

Korea, Republic of
Pusan National University Hospital
Busan

Korea, Republic of
Inje University Haeundae Paik Hospital
Busan

Korea, Republic of
Yeungnam University Medical Center
Daegu

Korea, Republic of
Hanyang University Guri Hospital
Guri-si

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si

Korea, Republic of
Severance Hospital
Seoul

Korea, Republic of
Samsung Medical Center
Seoul

Korea, Republic of
Seoul National University Hospital
Seoul

Korea, Republic of
Kangbuk Samsung Hospital
Seoul

Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul

Korea, Republic of
St. Vincent's Hospital
Suwon

Latvia
P. Stradins Clinical University Hospital
Riga

Latvia
Digestive Diseases Center Gastro
Riga

Latvia
Riga East Clinical University Hospital clinic Gailezers
Riga

Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas

Lithuania
Klaipeda University Hospital
Klaipeda

Lithuania
Vilnius University Hospital Santariskes Clinics
Vilnius

Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius

Lithuania
Vilnius City Clinical Hospital
Vilnius

Mexico, Jalisco
Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V.
Zapapan

Mexico, Nuevo León
Centro Regiomontano de Estudios Clinicos Roma SC.
Monterrey

Mexico, Nuevo León
Instituto Tecnológico y de Estudios Superiores de Monterrey
Monterrey

Mexico, Querétaro
SMIQ
Santiago de Queretaro

Mexico
Hospital Christus Muquerza del Parque S.A. de C.V.
Chihuahua

Mexico
Centro de Investigacion Clinica Acelerada (CICA) S.C.
Mexico

Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Tlalpan

Moldova, Republic of
"Sfanta Treime" Clinical Municipal Hospital
Chisinau

Moldova, Republic of
Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery
Chisinau

Moldova, Republic of
"Sf. Arhanghel Mihail" Municipal Clinical Hospital
Chisinau

Moldova, Republic of
Republican Clinical Hospital, Department of Colorectal Surgery
Chisinau

Moldova, Republic of
Republican Clinical Hospital
Chisinau

Netherlands
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam

Netherlands
Academisch Medisch Centrum
Amsterdam

Netherlands
UMC Groningen
Groningen

Netherlands
Radboud University Medical Center
Nijmegen

Netherlands
Zuyderland Medisch Centrum
Sittard-Geleen

Netherlands
St. Elisabeth Ziekenhuis
Tilburg

Norway
Akershus University Hospital
Lørenskog

Norway
Lovisenberg Diakonale Sykehus
Oslo

Portugal
Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra
Coimbra

Portugal
Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes
Guimaraes

Portugal
Hospital Beatriz Angelo
Loures

Portugal
Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
Viana do Castelo

Romania
Hyperclinica MedLife Grivita
Bucharest

Romania
Center of Diagnosis and Treatment Provita
Bucharest

Romania
Fundeni Clinical Institute
Bucharest

Romania
Bucharest University Emergency Hospital, Department of Internal Medicine II
Bucharest

Romania
Dr. Carol Davila Central Military Emergency Clinical Hospital
Bucharest

Romania
Craiova County Emergency Clinical Hospital
Craiova

Romania
Colentina Clinical Hospital
Napoca

Romania
Targu Mures County Emergency Clinical Hospital
Targu Mures

Russian Federation
Joint Venture Company Diagnostic Center, Bioterm Ltd.
Barnaul

Russian Federation
Territorial Clinical Hospital
Barnaul

Russian Federation
Regional Clinical Hospital #3
Chelyabinsk

Russian Federation
Chelyabinsk Regional Clinical Hospital
Chelyabinsk

Russian Federation
Chita State Medical Academy
Chita

Russian Federation
Ural State Medical Academy - Medical Association Novaya Bolnitsa
Ekaterinburg

Russian Federation
Irkutsk State Medical Academy of Postgraduate Education
Irkutsk

Russian Federation
Immanuel Kant Baltic Federal University
Kaliningrad

Russian Federation
Kaluga Regional Hospital
Kaluga

Russian Federation
City Clinical Hospital No 7 - Kazan
Kazan

Russian Federation
S.V. Beliaev Kemerovo Regional Clinical Hospital
Kemerovo

Russian Federation
Regional Clinical Hospital
Khanty-mansiysk

Russian Federation
Federal Siberian Research and Clinical Center
Krasnoyarsk

Russian Federation
Moscow Clinical Scientific and Practical Center
Moscow

Russian Federation
City Clinical Hospital n.a. V.M. Buyanov
Moscow

Russian Federation
City Clinical Hospital 24
Moscow

Russian Federation
CJSC Nasledniki
Moscow

Russian Federation
A.N. Ryzhikh State Research Center for Coloproctology
Moscow

Russian Federation
Railway Station Clinical Hospital
Nizhny Novgorod

Russian Federation
Novosibirskiy Gastrocenter
Novosibirsk

Russian Federation
Medical Center Sibnovomed LLC
Novosibirsk

Russian Federation
Scientific Research Institute of Physiology and Basic Medicine
Novosibirsk

Russian Federation
Euromed Multi-Specialty Center for Contemporary Medicine LLC
Omsk

Russian Federation
Medical Diagnostic Center LLC
Orenburg

Russian Federation
N.N. Burdenko Penza Regional Clinical Hospital
Penza

Russian Federation
Republican Hospital na VA Baranov
Petrozavodsk

Russian Federation
Evromedservis
Pushkin

Russian Federation
Clinic UZI 4D, LLC
Pyatigorsk

Russian Federation
Pyatigorsk City Hospital 2
Pyatigorsk

Russian Federation
Rostov State Medical University
Rostov-on-Don

Russian Federation
Medical Center Reavita Med Spb LLC
Saint Petersburg

Russian Federation
City Clinical Hospital No 31 - St. Petersburg
Saint Petersburg

Russian Federation
S.M. Kirov Military Medical Academy
Saint-Petersburg

Russian Federation
Medical University REAVIZ
Samara

Russian Federation
Samara Station Railway Clinical Hospital under OAO Russian Railways
Samara

Russian Federation
Regional Clinical Hospital
Saratov

Russian Federation
Sochi City Hospital No 5
Sochi

Russian Federation
S.M. Kirov Military Medical Academy
St Petersburg

Russian Federation
Oncology Center of Moskovskiy District
St Petersburg

Russian Federation
City Outpatient Care Unit No 38
St. Petersburg

Russian Federation
I.I. Mechnikov North-Western State Medical University
St. Petersburg

Russian Federation
State Unitary Enterprise Passengeravtotrans
St. Petersburg

Russian Federation
Clinical and Diagnostic Center with an outpatient department under the Presidential Executive Office
St. Petersburg

Russian Federation
SPb SBIH City Hospital of Saint Martyr Elizaveta
St. Petersburg

Russian Federation
Medical Center Eko-Bezopasnost LLC
St. Petersburg

Russian Federation
Budget Institution of the Khanty-Mansiysk Autonomous Okrug - Ugra Surgut Regional Clinical Hospital
Surgut

Russian Federation
Tomsk Regional Clinical Hospital
Tomsk

Russian Federation
Tula Regional Clinical Hospital
Tula

Russian Federation
G.G. Kuvatov Republican Clinical Hospital
Ufa

Russian Federation
City Clinical Hospital #21
Ufa

Russian Federation
Ulyanovsk Regional Clinical Hospital
Ulyanovsk

Russian Federation
Novgorod Regional Clinical Hospital
Veliky Novgorod

Russian Federation
Regional Clinical Hospital
Vladimir

Russian Federation
Primorsky Regional Clinical Hospital No.1
Vladivostok

Russian Federation
Medical Center of Far-Eastern Federal University
Vladivostok

Russian Federation
Medical Scientific Manufacturing Association Dvizheniye Clinic
Volgograd

Saudi Arabia
King Fahad Specialist Hospital
Dammam

Saudi Arabia
King Abdul Aziz University Hospital
Jeddah

Saudi Arabia
King Saud Medical Complex
Riyadh

Saudi Arabia
King Fahad National Guard Hospital
Riyadh

Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine
Belgrade

Serbia
Clinical Hospital Center - Dr. Dragisa Misovic-Dedinje
Belgrade

Serbia
Clinical Hospital Center Zvezdara Clinic of Internal Diseases
Belgrade

Serbia
Military Medical Academy, Clinic of Gastroenterology and Hepatology
Belgrade

Serbia
Clinical Center Kragujevac
Kragujevac

Serbia
Clinical Center of Vojvodina, Clinic of Gastroenterology and Hepatology
Novi Sad

Serbia
General Hospital Pancevo
Pancevo

Serbia
General Hospital Djordje Jovanovic Zrenjanin
Zrenjanin

Slovakia
Cliniq, s.r.o.
Bratislava

Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava

Slovakia
Brezno gastroenterology center s.r.o.
Brezno

Slovakia
KM Management, spol. s r.o.
Nitra

Slovakia
Gastromedic s.r.o.
Nove Zamky

Slovakia
GASTRO I., s.r.o.
Presov

Slovakia
World of the Health Inc. General Hospital Rimavska Sobota
Rimavska Sobota

Slovenia
General Hospital Celje
Celje

South Africa
Ahmed Kathrada Private Hospital
Gauteng

South Africa
Emmed Research
Pretoria

Spain
General University Hospital of Alicante
Alicante

Spain
University Hospital Germans Trias i Pujol
Badalona

Spain
Teknon Medical Center
Barcelona

Spain
University Hospital Reina Sofia
Cordoba

Spain
University Hospital of Girona Dr. Josep Trueta
Girona

Spain
University Hospital of the Canary Islands (HUC) La Laguna
La Laguna

Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria

Spain
University Hospital de La Princesa
Madrid

Spain
Hospital Clinico San Carlos
Madrid

Spain
University Hospital La Paz
Madrid

Spain
University Hospital Puerta de Hierro Majadajonda
Majadahonda, Madrid

Spain
University Hospital Marques de Valdecilla (HUMV)
Santander

Spain
University Hospital Virgen Macarena
Sevilla

Spain
University Hospital Virgen del Rocio
Sevilla

Spain
University Clinical Hospital of Valencia
Valencia

Spain
Viladecans Hospital
Viladecans

Spain
University Hospital Miguel Servet
Zaragoza

Sweden
Saint Goran Hospital
Stockholm

Sweden
Ersta Hospital
Stockholm

Switzerland
Lindenhofspital
Bern

Switzerland
Cantonal Hospital Saint Gallen
St.Gallen

Switzerland
University Hospital Zurich
Zurich

Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, San Ming Dist.

Taiwan
E-DA Hospital
Kaohsiung

Taiwan
Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi
Kozlu

Taiwan
Chang Gung Medical Foundation, Kaohsiung Memorial Hospital
Niao-Sung Hsiang Kaohsiung County

Taiwan
National Cheng Kung University Hospital
Tainan, Taiana

Taiwan
Chang Gung Memorial Hospital- Linkou
Taoyuan City

Taiwan
Taipei Veterans General Hospital
Tapei, Beitou Dist.

Taiwan
National Taiwan University Hospital
Tapei

Turkey
Hacettepe Universitesi
Ankara

Turkey
Ankara University Medical Faculty Cebeci Hospital
Ankara

Turkey
Uludag Universitesi Tip Fakultesi
Bursa

Turkey
Firat University Medical Faculty
Elazig

Turkey
Bezmialem Foundation University Medical Faculty
Istanbul

Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul

Turkey
Sultan Abdulhamid Han Egitim ve Arastirma Hastanesi
Istanbul

Turkey
Marmara University
Istanbul

Turkey
Istanbul Medeniyet Uni Goztepe Training&Res Hosp
Istanbul

Turkey
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadiköy/Istanbul

Turkey
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
Trabzon

Ukraine
Chernivtsi Regional Clinical Hospital
Chernivtsi

Ukraine
Chernivtsi Regional Clinical Hospital
Chernivtsi

Ukraine
Dnipropetrovsk II Mechnykov Regional Clinical Hospital Surgery Department 2
Dnipropetrovsk

Ukraine
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases
Dnipropetrovsk

Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk

Ukraine
Ivano-Frankivsk Central City Clinical Hospital
Ivano-Frankivsk

Ukraine
V.T. Zaitsev Institute of General and Emergency Surgery
Kharkiv

Ukraine
Kharkiv City Clinical Hospital 2
Kharkiv

Ukraine
Khmelnytskyi Regional Hospital
Khmelnytskyi

Ukraine
Medical and Diagnostic Center Acinus
Kropyvnytskyi

Ukraine
Medical Center Medical Clinic Blagomed LLC
Kyiv

Ukraine
Kyiv City Clinical Hospital #18
Kyiv

Ukraine
Kyiv City Clinical Hospital #18
Kyiv

Ukraine
BIK-KYIV Ukrainian German Gastroenterology Center
Kyiv

Ukraine
Medical Center Consilium Medical
Kyiv

Ukraine
Ok Clinic Medical Center within International Institute of Clinical Trials, LLC
Kyiv

Ukraine
Kyiv Regional Hospital #2
Kyiv

Ukraine
Kyiv Regional Clinical Hospital
Kyiv

Ukraine
Volyn Regional Clinical Hospital
Lutsk

Ukraine
Lviv Regional Clinical Hospital
Lviv

Ukraine
Public City Clinical Hospital of Emergency Medical Care
Lviv

Ukraine
Odesa Regional Clinical Hospital Regional Gastroenterology Center Surgery Department
Odesa

Ukraine
Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council
Poltava

Ukraine
Ternopil City Public Emergency Medical Care Hospital
Ternopil

Ukraine
Vinnytsia City Clinical Hospital #1
Vinnytsia

Ukraine
Vinnytsia M.I. Pyrohov Regional Clinical Hospital
Vinnytsia

Ukraine
Health Clinic, LLC
Vinnytsya

Ukraine
Multidisciplinary Clinic of the St. Nicholas, LLC
Zaporizhia

Ukraine
Zaporizhzhya Regional
Zaporizhzhya

Ukraine
First Private Clinic
Zhytomyr

United Kingdom
Bristol Royal Infirmary
Bristol

United Kingdom
Ulster Hospital
Dundonald

United Kingdom
Queen Elizabeth University Hospital
Glasgow

United Kingdom
Victoria Hospital Blackpool
Lancashire Blackpool

United Kingdom
Royal London Hospital
London

United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London

United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London

United Kingdom
John Radcliffe Hospital
Oxford

United Kingdom
Royal Shrewsbury Hospital
Shrewsbury

United Kingdom
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
Southampton

United Kingdom
Torbay Hospital
Torquay

Sponsors and Collaborators

Celgene

Investigators

Study Director: Kanthi Kollengode, MD Celgene

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03467958 History of Changes
  • Other Study ID Numbers: RPC01-3204, U1111-1203-8203, 2017-004295-55
  • First Posted: March 16, 2018 Key Record Dates
  • Last Update Posted: February 15, 2021
  • Last Verified: February 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Crohn Disease
    Crohn's Disease
    RPC01-3204
    RPC01
    Severely active
    Moderately active
    Ozanimod
    Oral
  • Additional relevant MeSH terms: Crohn Disease