A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

NCT ID: NCT05242484

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

577 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-19

Study Completion Date

2029-03-27

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

Detailed Description

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Conditions

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Colitis, Ulcerative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1: Placebo

Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered as subcutaneous injection.

Group 2: Guselkumab

Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Group Type EXPERIMENTAL

Guselkumab

Intervention Type BIOLOGICAL

Guselkumab will be administered as subcutaneous injection.

Group 3: Golimumab

Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Group Type EXPERIMENTAL

Golimumab

Intervention Type BIOLOGICAL

Golimumab will be administered as subcutaneous injection.

Group 4: JNJ-78934804 (High-dose)

Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Group Type EXPERIMENTAL

JNJ-78934804

Intervention Type BIOLOGICAL

JNJ-78934804 will be administered subcutaneously as per defined regimen.

Group 5: JNJ-78934804 (Mid-dose)

Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Group Type EXPERIMENTAL

JNJ-78934804

Intervention Type BIOLOGICAL

JNJ-78934804 will be administered subcutaneously as per defined regimen.

Group 6: JNJ-78934804 (Low-dose)

Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Group Type EXPERIMENTAL

JNJ-78934804

Intervention Type BIOLOGICAL

JNJ-78934804 will be administered subcutaneously as per defined regimen.

Interventions

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Guselkumab

Guselkumab will be administered as subcutaneous injection.

Intervention Type BIOLOGICAL

Golimumab

Golimumab will be administered as subcutaneous injection.

Intervention Type BIOLOGICAL

JNJ-78934804

JNJ-78934804 will be administered subcutaneously as per defined regimen.

Intervention Type BIOLOGICAL

Placebo

Placebo will be administered as subcutaneous injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
* Moderately to severely active UC as assessed by the modified Mayo score
* Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
* If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria

* Has severe extensive colitis as defined in the protocol
* Extent of inflammatory disease limited to the rectum
* Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
* Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
* Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Valley Gastroenterology Medical Group

Arcadia, California, United States

Site Status

Southern California Research Center

Coronado, California, United States

Site Status

Om Research LLC

Lancaster, California, United States

Site Status

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Site Status

Medical Research Center of Connecticut

Hamden, Connecticut, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Pioneer Research Solutions Inc.

Coconut Creek, Florida, United States

Site Status

Digestive and Liver Disease Institute

Kissimmee, Florida, United States

Site Status

Osceola Regional Hospital

Kissimmee, Florida, United States

Site Status

Florida Research Center Inc.

Lakewood Rch, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Gastroenterology Group Of Naples

Naples, Florida, United States

Site Status

Omega Research Consultants

Orlando, Florida, United States

Site Status

Synergy Clinical Research

St. Petersburg, Florida, United States

Site Status

GCP Clinical Research

Tampa, Florida, United States

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Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Site Status

Gastroenterolgy Associates of Central GA

Macon, Georgia, United States

Site Status

Atlanta Gastroenterology Associates

Marietta, Georgia, United States

Site Status

Gastrointestinal Specialists of Georgia

Marietta, Georgia, United States

Site Status

Gastroenterology Consultants

Roswell, Georgia, United States

Site Status

Grand Teton Gastroenterology

Idaho Falls, Idaho, United States

Site Status

IU Health University Hospital

Indianapolis, Indiana, United States

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Gastroenterology of Southern Indiana

New Albany, Indiana, United States

Site Status

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky, United States

Site Status

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Site Status

Jewish Hospital

Louisville, Kentucky, United States

Site Status

Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Brigham And Women's Hospital

Chestnut Hill, Massachusetts, United States

Site Status

Huron Gastroenterology Associates Center for Digestive Care

Ypsilanti, Michigan, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Las Vegas Medical Research

Las Vegas, Nevada, United States

Site Status

Care Access Las Vegas

Las Vegas, Nevada, United States

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Dartmouth Hitchcock

Lebanon, New Hampshire, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Lenox Hill Hospital

New York, New York, United States

Site Status

Mohawk Valley Endoscopy Center

Utica, New York, United States

Site Status

University North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Tryon Medical Group

Charlotte, North Carolina, United States

Site Status

Onsite Clinical Solutions

Charlotte, North Carolina, United States

Site Status

Care Access Research, Kinston

Kinston, North Carolina, United States

Site Status

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Site Status

Frontier Clinical Research

Uniontown, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

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Digestive Disease Associates

Rock Hill, South Carolina, United States

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Gastro One

Germantown, Tennessee, United States

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Etsu Quillen College Of Medicine

Johnson City, Tennessee, United States

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

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UT Southwestern Medical Center

Dallas, Texas, United States

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GI Specialists of Houston

Houston, Texas, United States

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Gastroenterology Clinic Of San Antonio P A

San Antonio, Texas, United States

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Texas Digestive Disease Consultants

Southlake, Texas, United States

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Tyler Research Institute, LLC

Tyler, Texas, United States

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Medical College Of Virginia Hospital

Richmond, Virginia, United States

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Washington Gastroenterology, PLLC

Bellevue, Washington, United States

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Swedish Medical Center

Seattle, Washington, United States

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Virginia Mason Medical Center

Seattle, Washington, United States

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Digestive Health Specialists

Tacoma, Washington, United States

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Medical College Of Wisconsin

Milwaukee, Wisconsin, United States

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CIPREC

Buenos Aires, , Argentina

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Hospital Britanico de Buenos Aires

Buenos Aires, , Argentina

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Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo

Ciudad Autonoma Buenos Aires, , Argentina

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Sanatorio Duarte Quiroz

Córdoba, , Argentina

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Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, , Argentina

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Hospital Provincial del Centenario

Rosario, , Argentina

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Box Hill Hospital

Box Hill, , Australia

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Royal Prince Alfred Hospital

Camperdown, , Australia

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Monash Health, Monash Medical Centre

Clayton, , Australia

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Concord Hospital

Concord, , Australia

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Western Health

Footscray, , Australia

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Coastal Digestive Health

Maroochydore, , Australia

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Fiona Stanley Hospital

Murdoch, , Australia

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Royal Adelaide Hospital

North Terrace, , Australia

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Royal Melbourne Hospital

Parkville, , Australia

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The Alfred Hospital

Prahran, , Australia

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Mater Hospital Brisbane

South Brisbane, , Australia

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Universitaetsklinikum Salzburg Landeskrankenhaus

Salzburg, , Austria

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Krankenhaus der Barmherzigen Brüder

Vienna, , Austria

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Medizinische Universitaet Wien

Vienna, , Austria

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Klinikum Wels Grieskirchen

Wels, , Austria

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Imelda Ziekenhuis

Bonheiden, , Belgium

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Algemeen Ziekenhuis Sint-Jan

Bruges, , Belgium

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Cliniques Universitaires Saint Luc

Brussels, , Belgium

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AZ Maria Middelares

Ghent, , Belgium

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UZ Gent

Ghent, , Belgium

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UZ Leuven

Leuven, , Belgium

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CHC MontLegia

Liège, , Belgium

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CHU de Liege

Liège, , Belgium

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Vitaz

Sint-Niklaas, , Belgium

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Universidade Estadual Paulista 'Julio De Mesquita Filho'

Botucatu, , Brazil

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L2IP Instituto de Pesquisas Clinicas

Brasília, , Brazil

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Chronos Clinica Medica LTDA Chronos Pesquisa Clinica

Brasília, , Brazil

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Fundacao Universidade de Caxias do Sul

Caxias do Sul, , Brazil

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Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica

Curitiba, , Brazil

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Associacao Hospitalar Moinhos de Vento

Porto Alegre, , Brazil

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Hospital De Clinicas De Porto Alegre

Porto Alegre, , Brazil

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Hospital das Clinicas de Porto Alegre

Porto Alegre, , Brazil

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Universidade Federal do Rio de Janeiro - Faculdade de Medicina

Rio de Janeiro, , Brazil

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SER - Servicos Especializados em Reumatologia da Bahia

Salvador, , Brazil

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Pesquisare Saude

Santo André, , Brazil

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Irmandade da Santa Casa da Misericórdia de Santos

Santos, , Brazil

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Hospital Nove de Julho

São Paulo, , Brazil

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BR Trials

São Paulo, , Brazil

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Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE

São Paulo, , Brazil

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Instituto D Or de Pesquisa e Ensino IDOR

São Paulo, , Brazil

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Medical Centre Hipocrat

Haskovo, , Bulgaria

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Diagnostic Consulting Center I Sliven

Sliven, , Bulgaria

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UMHAT 'Tsaritsa Yoanna'

Sofia, , Bulgaria

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University Hospital Alexandrovska - Clinic of Nephrology

Sofia-Grad, , Bulgaria

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Medical Center -Medika Plus

Veliko Tarnovo, , Bulgaria

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Multriprofile Hospital for Active Treatment Hristo Botev

Vratsa, , Bulgaria

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Foothills Hospital

Calgary, Alberta, Canada

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Gastroenterology and Internal Medicine Research Institute (GIRI)

Edmonton, Alberta, Canada

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Covenant Health/Grey Nuns hospital

Edmonton, Alberta, Canada

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Columbia Gastroenterology

New Westminster, British Columbia, Canada

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The Gordon & Leslie Diamond Health Care Center

Vancouver, British Columbia, Canada

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GIRI Gastrointestinal Research Institute

Vancouver, British Columbia, Canada

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The Medical Arts Health Research Group

Vancouver, British Columbia, Canada

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PerCuro Clinical Research Ltd.

Victoria, British Columbia, Canada

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Health Sciences Centre

Winnipeg, Manitoba, Canada

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Viable Clinical Research

Dartmouth, Nova Scotia, Canada

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Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

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London Health Sciences Centre - University Campus

London, Ontario, Canada

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Toronto Immune and Digestive Health Institute Inc

Toronto, Ontario, Canada

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CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada

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McGill University - Health Centre - Montreal General Hospital

Montreal, Quebec, Canada

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CMIIM, Centre médical L'Enjeu

Mount Royal, Quebec, Canada

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St. Jerome Medical Research

Saint-Jérôme, Quebec, Canada

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Viable Clinical Research

Bridgewater, , Canada

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Hopital Chicoutimi

Saguenay, , Canada

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Hospital Clinico Regional Dr. Guillermo Grant Benavente

Concepción, , Chile

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Clinica Dermacross S A

Santiago, , Chile

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Complejo Asistencial Hospital Dr. Sótero del Río

Santiago, , Chile

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Centro de Estudios Clínicos e Investigación Médica (CeCim)

Santiago, , Chile

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China Japan Friendship Hospital

Chaoyang, , China

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West China Hospital Sichuan University

Chengdu, , China

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Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, , China

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Jinhua municipal central hospital

Jinhua, , China

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Zhongda Hospital Southeast University

Nanjing, , China

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Union Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, , China

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Opca bolnica Bjelovar

Bjelovar, , Croatia

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University Hospital Center Split

Split, , Croatia

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University Hospital Dubrava

Zagreb, , Croatia

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Vojenska nemocnice Brno

Brno, , Czechia

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ISCARE a.s.

Prague, , Czechia

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Aalborg Hospital

Aalborg, , Denmark

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Aarhus University Hospital

Aarhus, , Denmark

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Bispebjerg Og Frederiksberg Hospital

Copenhagen, , Denmark

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Herlev Hospital, University of Copenhagen

Herlev, , Denmark

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Odense Universitetshospital

Odense, , Denmark

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East Tallinn Central Hospital

Tallinn, , Estonia

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West Tallinn Central Hospital

Tallinn, , Estonia

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Tartu University Hospital

Tartu, , Estonia

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CHU Amiens - Hopital Sud

Amiens, , France

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Hopital Louis Mourier

Colombes, , France

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Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

Créteil, , France

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CHU Grenoble

Grenoble, , France

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Centre Hospitalier Départemental VENDEE

La Roche-sur-Yon, , France

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CHRU de Lille Hopital Claude Huriez

Lille, , France

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Hopital Nord Marseille

Marseille, , France

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Hopital Saint Eloi

Montpellier, , France

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Clinique Ambroise Pare

Neuilly-sur-Seine, , France

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CHU de Nice Hopital de l Archet

Nice, , France

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CHU Nimes Hopital Caremeau

Nîmes, , France

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Hopital Haut-Leveque, CMC Magellan

Pessac, , France

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Hospices Civils de Lyon HCL

Pierre-Bénite, , France

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CHU Saint Etienne

Saint-Etienne, , France

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Hopital de Rangueil

Toulouse, , France

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CHRU Nancy Brabois

Vandœuvre-lès-Nancy, , France

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Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, , Germany

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Praxis Fur Gastroenteroligie

Berlin, , Germany

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Charite - Universitaetsmedizin Berlin (CCM)

Berlin, , Germany

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Krankenhaus Waldfriede Mitte

Berlin, , Germany

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University Hospital Dresden

Dresden, , Germany

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Universitaetsklinik Erlangen

Erlangen, , Germany

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JWG-University Hospital

Frankfurt, , Germany

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Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

Frankfurt am Main, , Germany

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Universitatsklinikum Freiburg

Freiburg im Breisgau, , Germany

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Klinikum Fulda - Tumorklinik - Germany

Fulda, , Germany

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Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk

Halle, , Germany

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BSF Studiengesellschaft

Halle, , Germany

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Medizinische Hochschule Hannover

Hanover, , Germany

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Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd

Heidelberg, , Germany

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University Hospital Heidelberg

Heidelberg, , Germany

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Universitatsklinikum Jena

Jena, , Germany

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Praxisgemeinschaft Jerichow

Jerichow, , Germany

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Gastroenterologische Spezialpraxis - Berlin-Karlshorst

Karlshorst, , Germany

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Eugastro GmbH

Leipzig, , Germany

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Staedtisches Klinikum Lueneburg

Lüneburg, , Germany

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Universitaetsklinikum Mannheim

Mannheim, , Germany

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Gastroenterologische Gemeinschaftspraxis Minden

Minden, , Germany

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Klinikum der Universitaet Muenchen

Munich, , Germany

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Praxis fur Innere Medizin und Gastroenterologie

Münster, , Germany

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MVZ Portal 10

Münster, , Germany

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Medius Klinik Nurtingen

Nürtingen, , Germany

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Siloah St Trudpert Klinikum

Pforzheim, , Germany

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Zentrum für Gastroenterologie Saar MVZ GmbH

Saarbrücken, , Germany

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Universitaetsklinik Tuebingen

Tübingen, , Germany

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Universitatsklinikum Ulm

Ulm, , Germany

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Gemeinschaftspraxis Jakobeit

Wipperfürth, , Germany

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Universitatsklinikum Wurzburg

Würzburg, , Germany

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Sotiria General State Hospital of Chest Diseases

Athens, , Greece

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Alexandra General Hospital of Athens

Athens, , Greece

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Nikaia General Hospital

Piraeus, , Greece

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Hippokration Hospital

Thessaloniki, , Greece

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Obudai Egeszsegugyi Centrum Kft

Budapest, , Hungary

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Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, , Hungary

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Semmelweis Egyetem

Budapest, , Hungary

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Pannónia Magánorvosi Centrum Kft

Budapest, , Hungary

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Bugat Pal Korhaz

Gyöngyös, , Hungary

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Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp

Szeged, , Hungary

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Markusovszky Egyetemi Oktatokorhaz

Szombathely, , Hungary

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M S Ramaiah Medical College and Hospital

Bangalore, , India

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Siksha O Anusandhan University - Institute of Medical Scienc

Bhubaneswar, , India

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Apex Hospitals Ltd

Jaipur, , India

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G.B. Pant Hospital

New Delhi, , India

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All India Institute of Medical Sciences

New Delhi, , India

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Sir Ganga Ram Hospital

New Delhi, , India

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Fortis Hospital

New Delhi, , India

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Yashoda Super Speciality Hospitals

Secunderabad, , India

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Surat Institute of Digestive Sciences Hospitals

Surat, , India

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Haemek Medical Center - Afula

Afula, , Israel

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Rambam Medical Center

Haifa, , Israel

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Bnai Zion Medical Center

Haifa, , Israel

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Shaare Zedek Medical Center

Jerusalem, , Israel

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Hadassah Hebrew University Medical Center

Jerusalem, , Israel

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Rabin Medical Center Beilinson Campus

Petah Tikva, , Israel

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Kaplan Medical Center

Rehovot, , Israel

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

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The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

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Assaf Harofeh Medical Center

Tzrifin, , Israel

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Università degli Studi di Bari

Bari, , Italy

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A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale

Catania, , Italy

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AOU Policlinico G.Martino

Messina, , Italy

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Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele

Milan, , Italy

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Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato

Monserrato, , Italy

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Azienda Ospedaliera San Gerardo

Monza, , Italy

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Ospedale Sacro Cuore Don Calabria

Negrar, , Italy

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Ospedale Villa Sofia-Cervello

Palermo, , Italy

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Università Campus Biomedico di Roma

Roma, , Italy

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Policlinico Universitario Agostino Gemelli

Roma, , Italy

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IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali

Rozzano, , Italy

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Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

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Asahikawa Medical University Hospital

Asahikawa, , Japan

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Tokyo Medical and Dental University Hospital

Bunkyō City, , Japan

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Fukuoka University Chikushi Hospital

Chikushino-shi, , Japan

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Kitakyushu Municipal Medical Center

Fukuoka-ken, , Japan

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Gifu Prefectural General Medical Center

Gifu, , Japan

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Tokai University Hachioji Hospital

Hachiōji, , Japan

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Hamamatsu University Hospital

Hamamatsu, , Japan

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National Hospital Organization Hirosaki General Medical Center

Hirosaki, , Japan

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Hirosaki University Hospital

Hirosaki, , Japan

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Tokai University Hospital

Isehara, , Japan

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Kagoshima University Hospital

Kagoshima, , Japan

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Kagoshima IBD Gastroenterology Clinic

Kagoshima, , Japan

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Ofuna Chuo Hospital

Kamakura, , Japan

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Matsushima Clinic

Kanagawa, , Japan

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Nara Medical University Hospital

Kashihara, , Japan

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Tsujinaka Hospital Kashiwanoha

Kashiwa, , Japan

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Kobe University Hospital

Kobe, , Japan

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Yamanashi Prefectural Central Hospital

Kofu, , Japan

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Kumamoto University Hospital

Kumamoto, , Japan

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Kurume University Hospital

Kurume, , Japan

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University Hospital Kyoto Prefectural University of Medicine

Kyoto, , Japan

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Kyoto University Hospital

Kyoto, , Japan

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Gunma University Hospital

Maebashi, , Japan

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Kitasato University Kitasato Institute Hospital

Minatoku, , Japan

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Kyorin University Hospital

Mitaka, , Japan

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Iwate Medical University Hospital

Morioka, , Japan

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Nagoya University Hospital

Nagoya, , Japan

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Nagoya City University Hospital

Nagoya, , Japan

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The Hospital of Hyogo College of Medicine

Nishinomiya, , Japan

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Kinshukai Infusion Clinic

Osaka, , Japan

Site Status

National Hospital Organization Osaka National Hospital

Osaka, , Japan

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Osaka City University Hospital

Osaka, , Japan

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Japan Community Health Care Organization Osaka Hospital

Osaka, , Japan

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Ogaki Municipal Hospital

Ōgaki, , Japan

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Oita Red Cross Hospital

Ōita, , Japan

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Toho University Sakura Medical Center

Sakura, , Japan

Site Status

Sapporo Tokushukai Hospital

Sapporo, , Japan

Site Status

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

Sapporo, , Japan

Site Status

Sapporo Higashi Tokushukai Hospital

Sapporo, , Japan

Site Status

Sapporo IBD Clinic

Sapporo Chuo-ku, , Japan

Site Status

Tokyo Metropolitan Bokutoh Hospital

Sumida Ku, , Japan

Site Status

The Jikei University Hospital

Tokyo, , Japan

Site Status

Tokyo Saiseikai Central Hospital

Tokyo, , Japan

Site Status

National Hospital Organization Tokyo Medical Center

Tokyo, , Japan

Site Status

Tokyo Medical University Hospital

Tokyo, , Japan

Site Status

Oji General Hospital

Tomakomai, , Japan

Site Status

Toyama Prefectural Central Hospital

Toyama, , Japan

Site Status

Toyota Kosei Hospital

Toyota, , Japan

Site Status

Mie University Hospital

Tsu, , Japan

Site Status

University of Tsukuba Hospital

Tsukuba, , Japan

Site Status

Wakayama Medical University Hospital

Wakayama, , Japan

Site Status

Yokohama City University Medical Center

Yokohama, , Japan

Site Status

Istishari Hospital

Amman, , Jordan

Site Status

Jordan University Hospital

Amman, , Jordan

Site Status

Irbid Specialty Hospital

Irbid, , Jordan

Site Status

King Abdullah University Hospital

Irbid, , Jordan

Site Status

Academisch Medisch Centrum Universiteit van Amsterdam

Amsterdam, , Netherlands

Site Status

Albert Schweitzer Ziekenhuis

Dordrecht, , Netherlands

Site Status

Maastricht University Medical Centre

Maastricht, , Netherlands

Site Status

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Site Status

UMC Utrecht

Utrecht, , Netherlands

Site Status

Christchurch Hospital

Christchurch, , New Zealand

Site Status

Dunedin Hospital

Dunedin, , New Zealand

Site Status

Hutt Hospital

Lower Hutt, , New Zealand

Site Status

Wellington Hospital

Wellington, , New Zealand

Site Status

Alesund sjukehus

Ålesund, , Norway

Site Status

Vestre Viken HF Baerum Sykehus

Gjettum, , Norway

Site Status

Sykehuset Innlandet HF Gjøvik

Gjøvik, , Norway

Site Status

Akershus Universitetssykehus

Lørenskog, , Norway

Site Status

Oslo University Hospital HF Ulleval sykehus

Oslo, , Norway

Site Status

Universitetssykehuset Nord-Norge HF

Tromsø, , Norway

Site Status

Szpital Uniwersytecki No2

Bydgoszcz, , Poland

Site Status

Centrum Medyczne Plejady

Krakow, , Poland

Site Status

Centrum Medyczne Promed

Krakow, , Poland

Site Status

AmiCare Centrum Medyczne

Lodz, , Poland

Site Status

ETG Lublin

Lublin, , Poland

Site Status

Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.

Lublin, , Poland

Site Status

Allmedica

Nowy Targ, , Poland

Site Status

Wojewodzki Szpital Specjalistyczny w Olsztynie

Olsztyn, , Poland

Site Status

Synexus Polska Sp z o o

Poznan, , Poland

Site Status

Twoja Przychodnia

Poznan, , Poland

Site Status

Centrum Medyczne Medyk

Rzeszów, , Poland

Site Status

Endoskopia Sp z o.o.

Sopot, , Poland

Site Status

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

Site Status

Sonomed Sp. z o.o.

Szczecin, , Poland

Site Status

GASTROMED Sp. z o.o.

Torun, , Poland

Site Status

Centrum Zdrowia Matki Dziecka i Mlodziezy

Warsaw, , Poland

Site Status

Centralny Szpital Kliniczny Mswia

Warsaw, , Poland

Site Status

Reumatika-Centrum Reumatologii, NZOZ

Warsaw, , Poland

Site Status

NZOZ Vivamed

Warsaw, , Poland

Site Status

Bodyclinic Sp. z o.o. sp. k

Warsaw, , Poland

Site Status

Melita Medical Sp. z o.o.

Wroclaw, , Poland

Site Status

Centrum Medyczne Oporow

Wroclaw, , Poland

Site Status

Przychodnia Vistamed

Wroclaw, , Poland

Site Status

EuroMediCare Szpital Specjalistyczny z Przychodnia

Wroclaw, , Poland

Site Status

Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska

Włocławek, , Poland

Site Status

ETG Zamosc

Zamość, , Poland

Site Status

Centro Hospitalar de Lisboa Norte Hospital Santa Maria

Lisbon, , Portugal

Site Status

Uls Loures Odivelas - Hosp. Loures

Loures, , Portugal

Site Status

Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio

Portimão, , Portugal

Site Status

Centro Hospitalar de Entre o Douro e Vouga, E.P.E

Santa Maria da Feira, , Portugal

Site Status

Uls Gaia Espinho

Vila Nova de Gaia, , Portugal

Site Status

FNsP F.D.R. Banska Bystrica

Banská Bystrica, , Slovakia

Site Status

Cliniq s.r.o.

Bratislava, , Slovakia

Site Status

GASTRO I. s.r.o.

Prešov, , Slovakia

Site Status

Gastroenterology Department ENDOMED, s.r.o.

Vranov nad Topľou, , Slovakia

Site Status

Splosna bolnisnica Celje

Celje, , Slovenia

Site Status

Univerzitetni klinicni center Ljubljana

Ljubljana, , Slovenia

Site Status

Worthwhile Clinical Trials Lakeview Hospital

Benoni, , South Africa

Site Status

Mediclinic Panorama

Cape Town, , South Africa

Site Status

Groote Schur Hospital

Cape Town, , South Africa

Site Status

Practice Dr Naeem Moosa

Johannesburg, , South Africa

Site Status

Emmed Research

Pretoria, , South Africa

Site Status

Inje University Haeundae Paik Hospital

Busan, , South Korea

Site Status

Kosin University Gospel Hospital

Busan, , South Korea

Site Status

Yeungnam University Hospital

Daegu, , South Korea

Site Status

Chosun university hospital

Gwangju, , South Korea

Site Status

The Catholic university of Korea, St. Vincent's Hospital

Gyeonggi-do, , South Korea

Site Status

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, , South Korea

Site Status

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Gangnam Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

The Catholic University of Korea Seoul St.Mary's Hospital

Seoul, , South Korea

Site Status

Kyung Hee University Hospital

Seoul, , South Korea

Site Status

The Catholic University of Korea Seoul St.Mary's Hospital

Seoul, , South Korea

Site Status

Ajou University Hospital

Suwon, , South Korea

Site Status

Yonsei University Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status

Hosp Clinic de Barcelona

Barcelona, , Spain

Site Status

Hosp. Univ. La Paz

Madrid, , Spain

Site Status

Hosp. de Navarra

Pamplona, , Spain

Site Status

Hosp. Montecelo

Pontevedra, , Spain

Site Status

Corporacio Sanitari Parc Tauli

Sabadell, , Spain

Site Status

Hosp. Univ. Marques de Valdecilla

Santander, , Spain

Site Status

Hosp. Univ. de Torrejon

Torrejón de Ardoz, , Spain

Site Status

Hosp. Alvaro Cunqueiro

Vigo, , Spain

Site Status

Karolinska Universitetssjukhuset Solna

Solna, , Sweden

Site Status

Ersta sjukhus

Stockholm, , Sweden

Site Status

Universitatsspital Basel

Basel, , Switzerland

Site Status

Inselspital Universitatsspital Bern

Bern, , Switzerland

Site Status

Gastroenterologische Praxis Balsiger und Seibold

Bern, , Switzerland

Site Status

Kantonsspital St Gallen

Sankt Gallen, , Switzerland

Site Status

UniversitaetsSpital Zuerich

Zurich, , Switzerland

Site Status

Changhua Christian Hospital

Changhua, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status

National Taiwan University Hospital, Division of Infectious Diseases

Taipei, , Taiwan

Site Status

Chang-Gung Memorial Hospital, LinKou Branch

Taoyuan District, , Taiwan

Site Status

Royal Victoria Hospital

Belfast, , United Kingdom

Site Status

Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Site Status

Velocity Clinical Research

High Wycombe, , United Kingdom

Site Status

Chelsea And Westminster Hospital

London, , United Kingdom

Site Status

St Georges University Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

John Radcliffe Hospital

Oxford, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Lithuania Mexico Serbia Turkey (Türkiye) United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile China Croatia Czechia Denmark Estonia France Germany Greece Hungary India Israel Italy Japan Jordan Netherlands New Zealand Norway Poland Portugal Slovakia Slovenia South Africa South Korea Spain Sweden Switzerland Taiwan United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

78934804UCO2001

Identifier Type: OTHER

Identifier Source: secondary_id

2021-005528-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-504743-13-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109179

Identifier Type: -

Identifier Source: org_study_id