A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

NCT ID: NCT05197049

Last Updated: 2025-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-19

Study Completion Date

2028-10-30

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Detailed Description

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Conditions

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Crohn Disease

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: Guselkumab

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.

Group Type EXPERIMENTAL

Guselkumab Dose 1

Intervention Type DRUG

Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Guselkumab Dose 2

Intervention Type DRUG

Guselkumab (Dose 2) will be administered by SC injection.

Group 2: Guselkumab

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.

Group Type EXPERIMENTAL

Guselkumab Dose 1

Intervention Type DRUG

Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Guselkumab Dose 3

Intervention Type DRUG

Guselkumab (Dose 3) will be administered by SC injection.

Group 3: Placebo

Participants will receive placebo injection subcutaneously.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered by SC injection.

Interventions

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Guselkumab Dose 1

Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Intervention Type DRUG

Guselkumab Dose 2

Guselkumab (Dose 2) will be administered by SC injection.

Intervention Type DRUG

Guselkumab Dose 3

Guselkumab (Dose 3) will be administered by SC injection.

Intervention Type DRUG

Placebo

Placebo will be administered by SC injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Crohn's disease (CD) of at least 3 months in duration
* Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria

* Current diagnosis of ulcerative colitis or indeterminate colitis
* Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
* Unstable doses of concomitant Crohn's disease therapy
Minimum Eligible Age

18 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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Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

Site Status

Advanced Gastro P.C

Chandler, Arizona, United States

Site Status

Reliance Research

Scottsdale, Arizona, United States

Site Status

Moore Clinical Trials, LLC

Little Rock, Arkansas, United States

Site Status

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States

Site Status

Om Research LLC

Lancaster, California, United States

Site Status

United Gastroenterologists

Los Alamitos, California, United States

Site Status

Paul Wallace MD

Los Angeles, California, United States

Site Status

Clinnova Research

Orange, California, United States

Site Status

Digestive System Healthcare

Pasadena, California, United States

Site Status

Northshore Gastroenterology Research, LLC

San Diego, California, United States

Site Status

Clinical Applications Laboratories, Inc

San Diego, California, United States

Site Status

Santa Maria Gastroenterology

Santa Maria, California, United States

Site Status

Clinical Research of California

Walnut Creek, California, United States

Site Status

Amel Med LLC Research

Grand Junction, Colorado, United States

Site Status

Western Connecticut Health Network/Danbury Hospital

Danbury, Connecticut, United States

Site Status

Gastroenterology Associates of SW Florida

Clearwater, Florida, United States

Site Status

Pioneer Research Solutions Inc.

Coconut Creek, Florida, United States

Site Status

Omega Research Consultants

DeBary, Florida, United States

Site Status

Harmony Medical Research Institute, Inc.

Hialeah, Florida, United States

Site Status

Central Florida Gastro Research

Kissimmee, Florida, United States

Site Status

Community Research Foundation, Inc.

Miami, Florida, United States

Site Status

Gastroenterology Group Of Naples

Naples, Florida, United States

Site Status

Center for Digestive Health

Orlando, Florida, United States

Site Status

Central Florida Internists

Orlando, Florida, United States

Site Status

Synergy Clinical Research

St. Petersburg, Florida, United States

Site Status

Atlanta Gastroenterology Specialists, PC

Atlanta, Georgia, United States

Site Status

Agile Clinical Research Trials, LLC

Atlanta, Georgia, United States

Site Status

Atlanta Center For Gastroenterology

Decatur, Georgia, United States

Site Status

Gastroenterolgy Associates of Central GA

Macon, Georgia, United States

Site Status

Gastroenterology Consultants

Roswell, Georgia, United States

Site Status

USF Asthma, Allergy, Immunology Clinical Research Unit

Boise, Idaho, United States

Site Status

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, United States

Site Status

Lemah Creek Clinical Research

Oakbrook Terrace, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

BVL Clinical Research

Leawood, Kansas, United States

Site Status

Cotton O'Neil Digestive Health Center

Topeka, Kansas, United States

Site Status

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky, United States

Site Status

Tandem Clinical Research

Marrero, Louisiana, United States

Site Status

Institute for Digestive Health and Liver Disease

Baltimore, Maryland, United States

Site Status

Woodholme Gastroenterology Associates

Glen Burnie, Maryland, United States

Site Status

Digestive Health Specialists PC

Chelmsford, Massachusetts, United States

Site Status

FC Research, LLC

South Dartmouth, Massachusetts, United States

Site Status

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States

Site Status

Detroit Clinical Research Center

Livonia, Michigan, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

Smart Medical Research

Jackson Heights, New York, United States

Site Status

Crystal Run Healthcare LLP

Middletown, New York, United States

Site Status

New York Gastroenterology Associates

New York, New York, United States

Site Status

DiGiovanna Institute for Medical Education & Research

North Massapequa, New York, United States

Site Status

A1 Clinical Network

Queens, New York, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Onsite Clinical Solutions

Charlotte, North Carolina, United States

Site Status

Carolina Research

Greenville, North Carolina, United States

Site Status

Gastroenterology Associates of the Piedmont, P.A.

Winston-Salem, North Carolina, United States

Site Status

Central Ohio Endoscopy Center LLC

Columbus, Ohio, United States

Site Status

Dayton Gastroenterology, Inc

Dayton, Ohio, United States

Site Status

Great Lakes Gastroenterology

Mentor, Ohio, United States

Site Status

Oklahoma University Health Science Center

Oklahoma City, Oklahoma, United States

Site Status

Integris Baptist Office

Oklahoma City, Oklahoma, United States

Site Status

Central Sooner Research

Oklahoma City, Oklahoma, United States

Site Status

Essential Medical Research

Tulsa, Oklahoma, United States

Site Status

The Oregon Clinic

Portland, Oregon, United States

Site Status

Frontier Clinical Research

Smithfield, Pennsylvania, United States

Site Status

Gastroenterology Associates P.A.

Greenville, South Carolina, United States

Site Status

Carolina Health Specialists

Myrtle Beach, South Carolina, United States

Site Status

West Texas Clinical Research

Lubbock, Texas, United States

Site Status

Victoria Gastroenterology

Richmond, Texas, United States

Site Status

Gastroenterology Clinic Of San Antonio P A

San Antonio, Texas, United States

Site Status

Wellness Clinical Research

San Antonio, Texas, United States

Site Status

Texas Digestive Disease Consultants

Southlake, Texas, United States

Site Status

Digestive Health Specialists of Tyler

Tyler, Texas, United States

Site Status

Care Access Research- Salt Lake City

Salt Lake City, Utah, United States

Site Status

Burke Internal Medicine and Research

Burke, Virginia, United States

Site Status

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Site Status

Monash Health, Monash Medical Centre

Clayton, , Australia

Site Status

Coral Sea Clinical Research Institute

North Mackay, , Australia

Site Status

OLV Ziekenhuis Aalst

Aalst, , Belgium

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CHU Saint-Pierre

Brussels, , Belgium

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Hopital Erasme

Brussels, , Belgium

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Universitair Ziekenhuis Gent

Ghent, , Belgium

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Algemeen Ziekenhuis Delta

Roeselare, , Belgium

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University hospital Clinical centre Banja Luka

Banja Luka, , Bosnia and Herzegovina

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Clinical Center University of Sarajevo

Sarajevo, , Bosnia and Herzegovina

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Polyclinic Dr. Al-Tawil

Sarajevo, , Bosnia and Herzegovina

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General Hospital Tesanj

Tešanj, , Bosnia and Herzegovina

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Plava poliklinika Tuzla

Tuzla, , Bosnia and Herzegovina

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Cantonal Hospital Zenica

Zenica, , Bosnia and Herzegovina

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Universidade Estadual Paulista 'Julio De Mesquita Filho'

Botucatu, , Brazil

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CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia

Brasília, , Brazil

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Chronos Clinica Medica Ltda

Brasília, , Brazil

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Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

Campinas, , Brazil

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CDC - Centro Digestivo de Curitiba

Curitiba, , Brazil

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Universidade Federal Do Ceara

Fortaleza, , Brazil

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Centro de Estudos Clínicos do Interior Paulista - CECIP

Jaú, , Brazil

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Cliged

Macaé, , Brazil

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Liga Norte Riograndense Contra O Cancer

Natal, , Brazil

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Instituto Mederi de Pesquisa e Saude

Passo Fundo, , Brazil

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Associacao Hospitalar Moinhos de Vento

Porto Alegre, , Brazil

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Hospital das Clinicas de Porto Alegre

Porto Alegre, , Brazil

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Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles

Porto Alegre, , Brazil

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NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, , Brazil

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Hospital das Clinicas - Universidade Federal de Pernambuco

Recife, , Brazil

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Universidade Federal da Bahia - Hospital Professor Edgard Santos

Salvador, , 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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CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo do Campo, , Brazil

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Kaiser Hospta

São José do Rio Preto, , Brazil

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Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

São José do Rio Preto, , Brazil

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BR TRIALS Ensaios Clinicos e Consultoria Ltda

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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Hepatogastro

São Paulo, , Brazil

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Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui

Teresina, , Brazil

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Integral Centro de Pesquisas Clinicas

Votuporanga, , Brazil

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London Health Sciences Centre

London, Ontario, Canada

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North Bay Dermatology Centre

North Bay, Ontario, Canada

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The Affiliated Hospital of Bengbu Medical College

Bengbu, , China

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Xiangya Hospital Central South University

Changsha, , China

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The second Xiangya Hospital of Central South University

Changsha, , China

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Changzhou No 2 Peoples Hospital

Changzhou, , China

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West China Hospital Sichuan University

Chengdu, , China

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Chongqing Medical University

Chongqing, , China

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The First People's Hospital of Foshan

Foshan, , China

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The First Affiliated Hospital of Fujian Medical University

Fuzhou, , China

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First Affiliated Hospital of Gannan Medical University

Ganzhou, , China

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Guangdong Provincial People's Hospital

Guangzhou, , China

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Guangzhou First Municipal People's Hospital

Guangzhou, , China

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Guangzhou Medical University

Guangzhou, , China

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Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Hangzhou, , China

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Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, , China

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The First Affiliated Hospital of Anhui Medical University

Hefei, , China

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The First Affiliated Hospital of NanChang University

Nanchang, , China

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Nanjing 1st Hospital

Nanjing, , China

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Nanjing Drum Tower Hospital

Nanjing, , China

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The First Hospital of Quanzhou

Quanzhou, , China

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Huashan Hospital Fudan University

Shanghai, , China

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Shanghai East Hospital

Shanghai, , China

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Shengjing Hospital Of China Medical University

Shenyang, , China

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The first affiliated hospital of suzhou University

Suzhou, , China

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Wuxi People s Hospital

Wuxi, , China

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Yangzhou First People's Hospital

Yangzhou, , China

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ZhuZhou Central Hospital

Zhuzhou, , China

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Opca bolnica Bjelovar

Bjelovar, , Croatia

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University Hospital Center Split

Split, , Croatia

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Opca bolnica Zadar

Zadar, , Croatia

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Poliklinika Solmed

Zagreb, , Croatia

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Fakultni nemocnice Brno

Brno, , Czechia

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Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

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Oblastni nemocnice Kladno a.s.

Kladno, , Czechia

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Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

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Nemocnice Slany

Slaný, , Czechia

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Sydvestjysk Sygehus

Esbjerg, , Denmark

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Nordsjaellands Hospital - Hillerod

Hilleroed, , Denmark

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Centre Hospitalier de la Cote Basque

Bayonne, , France

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CHRU Besancon Hopital Jean Minjoz

Besançon, , France

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Hopital Louis Mourier

Colombes, , France

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CHU de Nantes hotel Dieu

Nantes, , France

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CHU de Nice Hopital de l Archet

Nice, , France

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Hôpital Bichat

Paris, , France

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Hospices Civils de Lyon HCL

Pierre-Bénite, , France

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Hôpital Robert Debré

Reims, , France

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CHU Saint Etienne Hopital Nord

Saint-Priest-en-Jarez, , France

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CHRU Strasbourg

Strasbourg, , France

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CHU Rangueil

Toulouse, , France

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Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center

Berlin, , Germany

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DRK Kliniken Westend

Berlin, , Germany

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Krankenhaus Waldfriede Mitte

Berlin, , Germany

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Staedtisches Klinikum Braunschweig

Braunschweig, , Germany

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Evangelisches Krankenhaus Kalk

Cologne, , Germany

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Medizinisches Versorgungszentrum (MVZ) Dachau

Dachau, , Germany

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MVZ Sanaklinikum Duisburg

Duisburg, , Germany

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BSF Studiengesellschaft

Halle, , Germany

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Medizinische Hochschule Hannover

Hanover, , Germany

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Praxisgemeinschaft Jerichow

Jerichow, , Germany

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Gastroenterologische Spezialpraxis - Berlin-Karlshorst

Karlshorst, , Germany

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Universitaetsklinikum Mannheim

Mannheim, , Germany

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Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum

Nordhausen, , Germany

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Obudai Egeszsegugyi Centrum Kft

Budapest, , Hungary

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Egyesített Szent István és Szent László Kórház

Budapest, , Hungary

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Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu

Budapest, , Hungary

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Mh Egészségügyi Központ

Budapest, , Hungary

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Semmelweis Egyetem

Budapest, , Hungary

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Pannónia Magánorvosi Centrum Kft

Budapest, , Hungary

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Pest Megyei Flor Ferenc Korhaz

Kistarcsa, , Hungary

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Mohacsi Korhaz

Mohács, , Hungary

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Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika

Pécs, , Hungary

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Markusovszky Egyetemi Oktatokorhaz

Szombathely, , Hungary

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Haemek Medical Center

Afula, , Israel

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Soroka University Medical Center

Beersheba, , Israel

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The Chaim Sheba Medical Center

Ramat Gan, , Israel

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Kaplan Medical Center

Rehovot, , Israel

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Assaf Harofeh Medical Center

Tzrifin, , Israel

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Policlinico Sant'Orsola Malpighi

Bologna, , Italy

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Istituto Clinico Humanitas Rozzano, IRCCS

Milan, , 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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Juntendo University Hospital

Bunkyō City, , Japan

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Ginza central clinic

Chūōku, , Japan

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Fukui Prefectural Hospital

Fukui-ken, , Japan

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Fukuoka University Hospital

Fukuoka, , Japan

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Japanese Red Cross Fukuoka Hospital

Fukuoka, , Japan

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National Hospital Organization Fukuyama Medical Center

Fukuyama, , Japan

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Gamagori City Hospital

Gamagōri, , Japan

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Gunma University Hospital

Gunma, , Japan

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Hachinohe City Hospital

Hachinohe, , Japan

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Hamamatsu University Hospital

Hamamatsu, , Japan

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Matsuda Hospital

Hamamatsu, , Japan

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National Hospital Organization Mito Medical Center

Higashi-Ibaraki, , Japan

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Kure Kyosai Hospital

Hiroshima, , Japan

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National Hospital Organization Shikoku Cancer Center

Iizuka-shi, , Japan

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Kagoshima University Hospital

Kagoshima, , Japan

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Kagoshima IBD Gastroenterology Clinic

Kagoshima, , Japan

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Tsujinaka Hospital Kashiwanoha

Kashiwa, , Japan

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Kyushu Rosai Hospital

Kitakyushu, , Japan

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Kobe University Hospital

Kobe, , Japan

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Yamanashi Prefectural Central Hospital

Kofu, , Japan

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Dokkyo Medical University Saitama Medical Center

Koshigaya, , Japan

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Hidaka Coloproctologic Clinic

Kurume, , Japan

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Japanese Red Cross Kyoto Daini Hospital

Kyoto, , Japan

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University Hospital Kyoto Prefectural University of Medicine

Kyoto, , Japan

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Iwate Medical University Hospital

Morioka, , Japan

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Nagasaki University Hospital

Nagasaki, , Japan

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Yokoyama IBD Clinic

Nagoya, , Japan

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University of the Ryukyus Hospital

Nakagami-gun, , Japan

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Niigata University Medical And Dental Hospital

Niigata, , Japan

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Nishinomiya Municipal Central Hospital

Nishinomiya, , Japan

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Kinshukai Infusion Clinic

Osaka, , Japan

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National Hospital Organization Osaka National Hospital

Osaka, , Japan

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Japanese Red Cross Osaka Hospital

Osaka, , Japan

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Osaka General Medical Center

Osaka, , Japan

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Oita Red Cross Hospital

Ōita, , Japan

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Shiga University of Medical Science Hospital

Ōtsu, , Japan

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Sapporo Higashi Tokushukai Hospital

Sapporo, , Japan

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Takagi Clinic

Sendai, , Japan

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National Hospital Organization Shizuoka Medical Center

Sunto-gun, , Japan

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Tokyo Medical University Hospital

Tokyo, , Japan

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Toyota Kosei Hospital

Toyota, , Japan

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Yokohama City University Medical Center

Yokohama, , Japan

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Khalidi Hospital and Medical Center

Amman, , Jordan

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The Speciality Hospital (TSH) / Advanced Clinical Center

Amman, , Jordan

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Istiklal Hospital

Amman, , Jordan

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Abdali Hospital

Amman, , Jordan

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Irbid Specialty Hospital

Irbid, , Jordan

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King Abdullah University Hospital

Irbid, , Jordan

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Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

Kaunas, , Lithuania

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Vilnius University Hospital Santaros Klinikos, Public Institution

Vilnius, , Lithuania

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Hospital Sultanah Aminah

Johor Bharu, , Malaysia

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Hospital University Sains Malaysia

Kota Bharu, , Malaysia

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Hospital Raja Permaisuri Bainun

Kota Kinabalu, , Malaysia

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University Malaya Medical Centre

Kuala Lumpur, , Malaysia

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Hospital Tengku Ampuan Afzan

Kuantan, , Malaysia

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Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

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Sint Franciscus Gasthuis

Rotterdam, , Netherlands

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Elisabeth-TweeSteden Ziekenhuis

Tilburg, , Netherlands

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Christchurch Hospital

Christchurch, , New Zealand

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Dunedin Hospital

Dunedin, , New Zealand

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Gastromed Kralisz Romatowski Stachurska Sp. j.

Bialystok, , Poland

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10 Wojskowy Szpital Kliniczny z Poliklinika, SP ZOZ

Bydgoszcz, , Poland

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Centrum Medyczne Lukamed

Chojnice, , Poland

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Sahlgrenska University Hospital

Chrzanów, , Poland

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Private Practice - Dr. Krzysztof Cymerman

Gdynia, , Poland

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Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j.

Grudziądz, , Poland

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Malopolskie Centrum Kliniczne

Krakow, , Poland

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Centrum Medyczne Plejady

Krakow, , Poland

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Centrum Medyczne ProMiMed

Krakow, , Poland

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AmiCare Centrum Medyczne

Lodz, , Poland

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IP Clinic Sp. z o.o.

Lodz, , Poland

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Centrum Medyczne Med Gastr

Lodz, , Poland

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ETG Lublin

Lublin, , Poland

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Niepubliczny Zaklad Opieki Zdrowotnej

Lublin, , Poland

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Allmedica

Nowy Targ, , Poland

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Wojewodzki Szpital Specjalistyczny w Olsztynie

Olsztyn, , Poland

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Twoja Przychodnia

Opole, , Poland

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Centrum Medyczne

Piotrkow Trybunalski, , Poland

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EMC Instytut Medyczny SA PL CERTUS

Poznan, , Poland

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Synexus Polska Sp z o o

Poznan, , Poland

Site Status

Twoja Przychodnia

Poznan, , Poland

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Centrum Medyczne Medyk

Rzeszów, , Poland

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Centrum Medyczne Promed

Skorzewo, , Poland

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Endoskopia Sp z o.o.

Sopot, , Poland

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Kiepury Clinic

Sosnowiec, , Poland

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KO Med Centrum Medyczne

Straszów, , Poland

Site Status

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

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Sonomed Sp. z o.o.

Szczecin, , Poland

Site Status

GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii

Torun, , Poland

Site Status

H-T Centrum Medyczne Endoterapia

Tychy, , Poland

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Centrum Zdrowia Matki Dziecka i Mlodziezy

Warsaw, , Poland

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Endoterapia

Warsaw, , Poland

Site Status

Medical Concierge Centrum Medyczne

Warsaw, , Poland

Site Status

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, , Poland

Site Status

NZOZ Vivamed

Warsaw, , Poland

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Gabinety Lekarskie Bodyclinic

Warsaw, , Poland

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IBD Point Profesor Kierkus

Warsaw, , Poland

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Centrum Zdrowia Tuchow

Wierzchosławice, , Poland

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Melita Medical Sp. z o.o.

Wroclaw, , Poland

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Centrum Medyczne Melita Medical

Wroclaw, , Poland

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Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

Wroclaw, , Poland

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Przychodnia Vistamed

Wroclaw, , Poland

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

Włocławek, , Poland

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ETG Zamosc

Zamość, , Poland

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FNsP F.D.R. Banska Bystrica

Banská Bystrica, , Slovakia

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ENDOMED s.r.o

Košice, , Slovakia

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GASTRO I. s.r.o.

Prešov, , Slovakia

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Kyungpook National University Chilgok Hospital

Busan, , South Korea

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Inje University Haeundae Paik Hospital

Busan, , South Korea

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Kosin University Gospel Hospital

Busan, , South Korea

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DongA Medical Center

Busan, , South Korea

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Yeungnam University Medical Center

Daegu, , South Korea

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

Daejeon, , South Korea

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Kyung Hee University Hospital

Dongdaemun-gu, , South Korea

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Dongguk University Ilsan Hospital

Goyang-si, , South Korea

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Chonnam National University Hospital

Gwangju, , South Korea

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CHA Bundang Medical Center, CHA University

Gyeonggi-do, , South Korea

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

Gyeonggi-do, , South Korea

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Kangbuk Samsung Hospital

Seoul, , South Korea

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Yonsei University College of Medicine

Seoul, , South Korea

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Samsung Medical Center

Seoul, , South Korea

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The Catholic University of Korea Seoul St Mary s Hospital

Seoul, , South Korea

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Ajou University Hospital

Suwon, , South Korea

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Wonju Christian Hospital

Wŏnju, , South Korea

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Ewha Womans University Mokdong Hospital

Yangch’ŏn-gu, , South Korea

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Hosp. de Cabuenes

Gijón, , Spain

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Hosp. Gral. Juan Ramon Jimenez

Huelva, , Spain

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Hosp. Gral. Juan Ramon Jimenez

Huelva, , Spain

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Hosp. Univ. Infanta Leonor

Madrid, , Spain

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Hosp. Virgen Macarena

Seville, , Spain

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Hosp. Alvaro Cunqueiro

Vigo, , Spain

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Hosp. de La Marina Baixa

Villajoyosa, , Spain

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Kaohsiung Medical University Chung Ho Memorial Hospital

Kaoshiung, , Taiwan

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China Medical University Hospital

Taichung, , Taiwan

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National Taiwan University Hospital, Division of Infectious Diseases

Taipei, , Taiwan

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Taipei Medical University

Taipei, , Taiwan

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Linkou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

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Ankara Numune Egitim ve Arastirma Hastanesi

Ankara, , Turkey (Türkiye)

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Hacettepe University Hospital

Ankara, , Turkey (Türkiye)

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Gazi University Medical Faculty

Ankara, , Turkey (Türkiye)

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Acibadem Fulya Hospital

Istanbul, , Turkey (Türkiye)

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Ege Universitesi Tip Fakultesi

Izmir, , Turkey (Türkiye)

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Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

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Ondokuz Mayis University

Samsun, , Turkey (Türkiye)

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Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi

Zonguldak, , Turkey (Türkiye)

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Countries

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Austria Belarus Bulgaria Chile Estonia Finland Mexico Norway Portugal Russia Serbia Sweden Ukraine United Kingdom United States Australia Belgium Bosnia and Herzegovina Brazil Canada China Croatia Czechia Denmark France Germany Hungary Israel Italy Japan Jordan Lithuania Malaysia Netherlands New Zealand Poland Slovakia South Korea Spain Taiwan Turkey (Türkiye)

References

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Hart A, Panaccione R, Steinwurz F, Danese S, Hisamatsu T, Cao Q, Ritter T, Seidler U, Olurinde M, Vetter ML, Yee J, Yang Z, Wang Y, Johanns J, Han C, Sahoo A, Terry NA, Sands BE, D'Haens G; GRAVITI Study Group. Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn's Disease: Results From the Phase 3 GRAVITI Study. Gastroenterology. 2025 Aug;169(2):308-325. doi: 10.1053/j.gastro.2025.02.033. Epub 2025 Mar 18.

Reference Type DERIVED
PMID: 40113101 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CNTO1959CRD3004

Identifier Type: OTHER

Identifier Source: secondary_id

2020-006165-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-504737-41-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109125

Identifier Type: -

Identifier Source: org_study_id