Clinical trial NCT05242471: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
Official title: A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-02-16
Enrollment: 703
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
* Confirmed diagnosis of moderate to severe CD as assessed by Crohn'

Primary outcomes:
measure: Percentage of Participants with Clinical Remission at Week 48
timeFrame: Week 48
measure: Percentage of Participants with Endoscopic Response at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48
timeFrame: Week 48
measure: Percentage of Participants with Endoscopic Remission at Week 48
timeFrame: Week 48
measure: Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 48
timeFrame: Week 48
measure: Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48
timeFrame: Week 48
measure: Secondary Comparison: Percentage of Participants with Endoscopic Response at Week 48
timeFrame: Week 48
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to Week 48
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 48
measure: Clinical Laboratory Parameters Over Time
timeFrame: Up to Week 48
measure: Vital Sign Parameters Over Time
timeFrame: Up to Week 48
measure: Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Up to Week 48
measure: Serum Concentrations of Guselkumab Over Time
timeFrame: Up to Week 48
measure: Serum Concentrations of Golimumab Over Time
timeFrame: Up to Week 48
measure: Percentage of Participants with Antibodies to Guselkumab
timeFrame: Up to Week 48
measure: Titers of Antibodies to Guselkumab
timeFrame: Up to Week 48
measure: Percentage of Participants with Antibodies to Golimumab
timeFrame: Up to Week 48
measure: Titers of Antibodies to Golimumab
timeFrame: Up to Week 48
measure: Percentage of Participants with Neutralizing Antibodies to Guselkumab.
timeFrame: Up to Week 48
measure: Percentage of Participants with Neutralizing Antibodies to Golimumab
timeFrame: Up to Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Liver Center
state: Alabama
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Little Rock
country: United States
facility: Moore Clinical Trials, LLC
state: Arkansas
city: Apple Valley
country: United States
facility: Om Research LLC
state: California
city: Arcadia
country: United States
facility: Valley Gastroenterology Medical Group
state: California
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Lancaster
country: United States
facility: Desert Gastroenterology Associates
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: Orange
country: United States
facility: UCI Irvine Medical Center
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Hamden
country: United States
facility: Medical Research Center of Connecticut
state: Connecticut
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Coconut Creek
country: United States
facility: Pioneer Research Solutions Inc.
state: Florida
city: Homestead
country: United States
facility: Homestead Associates in Research Inc
state: Florida
city: Kissimmee
country: United States
facility: Osceola Mental Health D/B/A Park Place Behavioral Health Care
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Center Inc.
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group Of Naples
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Saint Petersburg
country: United States
facility: Synergy Clinical Research
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Atlanta
country: United States
facility: University of Mississippi Medical Center
state: Georgia
city: Macon
country: United States
facility: Gastroenterolgy Associates of Central GA
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
city: New Albany
country: United States
facility: Gastroenterology of Southern Indiana
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Digestive Health Center
state: Kansas
city: Wichita
country: United States
facility: Ascension via Christi Research
state: Kansas
city: Wichita
country: United States
facility: Univ. of KS School of Med
state: Kansas
city: Crestview Hills
country: United States
facility: Tri-State Gastroenterology Assoc
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Lafayette
country: United States
facility: Gastroenterology Clinic of Acadiana
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Boston
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Brigham And Women's Hospital
state: Massachusetts
city: South Dartmouth
country: United States
facility: FC Research, LLC
state: Massachusetts
city: Livonia
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates Center for Digestive Care
state: Michigan
city: Flowood
country: United States
facility: Gastrointestinal Associates LLP
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Las Vegas
country: United States
facility: Care Access Las Vegas
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock
state: New Hampshire
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: Jackson Heights
country: United States
facility: A1 Clinical Research
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Utica
country: United States
facility: Mohawk Valley Endoscopy Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Tryon Medical Group
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Westlake
country: United States
facility: Northshore Gastroenterology Research, LLC
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Harrisburg
country: United States
facility: Susquehanna Gastroenterology Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania - Perelman School of Medicine
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Rock Hill
country: United States
facility: Digestive Disease Associates
state: South Carolina
city: Germantown
country: United States
facility: Saint Francis Hospital
state: Tennessee
city: Hixson
country: United States
facility: Galen Medical Group
state: Tennessee
city: Johnson City
country: United States
facility: Etsu Quillen College Of Medicine
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Amel Med LLC Research
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Clinic Of San Antonio P A
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Tyler
country: United States
facility: Digestive Health Specialists
state: Texas
city: Ogden
country: United States
facility: Care Access Research, Ogden
state: Utah
city: Salt Lake City
country: United States
facility: Care Access Research- Salt Lake City
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire Veterans Affairs Medical Center
state: Virginia
city: Bellevue
country: United States
facility: Washington Gastroenterology, PLLC
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Digestive Disease Center
state: Washington
city: Tacoma
country: United States
facility: Digestive Health Specialists
state: Washington
city: Huntington
country: United States
facility: Marshall Health Clinical Research Center
state: West Virginia
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
city: Box Hill
country: Australia
facility: Box Hill Hospital
city: Clayton
country: Australia
facility: Monash Health, Monash Medical Centre
city: Footscray
country: Australia
facility: Western Health
city: Melbourne
country: Australia
facility: St Vincent's hospital
city: Newtown
country: Australia
facility: Royal Prince Alfred Hospital
city: North Terrace
country: Australia
facility: Royal Adelaide Hospital
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Penrith
country: Australia
facility: Nepean Hospital
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane Inflammatory Bowel Diseases
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg, Universitätsklinik f. Innere Medizin III
city: Vienna
country: Austria
facility: Akh Wien
city: Wels
country: Austria
facility: Klinikum Wels Grieskirchen
city: Wien
country: Austria
facility: Akh Wien
city: Antwerpen
country: Belgium
facility: GZA Ziekenhuizen
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Jan
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHU de Liege
city: Liège
country: Belgium
facility: CHC MontLegia
city: Mechelen
country: Belgium
facility: Az Sint-Maarten
city: Roeselare
country: Belgium
facility: Algemeen Ziekenhuis Delta
city: Sint-Niklaas
country: Belgium
facility: Vitaz
city: Belo Horizonte - MG
country: Brazil
facility: Hospital Das Clinicas Da Ufmg
city: Botucatu
country: Brazil
facility: Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
city: Brasilia
country: Brazil
facility: Impar Servicos Hospitalares S/A - Hospital Brasilia
city: Brasilia
country: Brazil
facility: Chronos Clinica Medica Ltda
city: Curitiba
country: Brazil
facility: Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica
city: Jau
country: Brazil
facility: Centro de Estudos Clínicos do Interior Paulista - CECIP
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
city: Ribeirao Preto
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro - Faculdade de Medicina
city: Santo Andre
country: Brazil
facility: Pesquisare Saude
city: Santos
country: Brazil
facility: Irmandade da Santa Casa da Misericórdia de Santos
city: Sao Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica LTDA ME
city: Sao Paulo
country: Brazil
facility: Hospital Nove de Julho
city: Sao Paulo
country: Brazil
facility: Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
city: Sao Paulo
country: Brazil
facility: Hepatogastro
city: Sao Paulo
country: Brazil
facility: BR Trials
city: São José Do Rio Preto
country: Brazil
facility: Kaiser Hospta
city: São Paulo
country: Brazil
facility: CPCLIN - Centro de Pesquisas Clínicas
city: São Paulo
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino IDOR
city: Sofia
country: Bulgaria
facility: UMHAT 'Aleksandrovska' EAD
city: Sofia
country: Bulgaria
facility: MHAT Tzaritza Joanna
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Gastroenterology and Internal Medicine Research Institute (GIRI)
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Covenant Health/Grey Nuns hospital
state: Alberta
city: New Westminster
country: Canada
facility: Fraser Clinical Trials Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: The Gordon & Leslie Diamond Health Care Center
state: British Columbia
city: Vancouver
country: Canada
facility: GIRI Gastrointestinal Research Institute
state: British Columbia
city: Vancouver
country: Canada
facility: The Medical Arts Health Research Group
state: British Columbia
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Centre
state: Manitoba
city: Dartmouth
country: Canada
facility: Viable Clinical Research
state: Nova Scotia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Barrie
country: Canada
facility: Barrie GI Associates
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Immune and Digestive Health Institute Inc
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
state: Quebec
city: Montreal
country: Canada
facility: McGill University - Health Centre - Montreal General Hospital
state: Quebec
city: Saint-Jerome
country: Canada
facility: St. Jerome Medical Research
state: Quebec
city: Ville Mont-Royal
country: Canada
facility: CMIIM, Centre médical L'Enjeu
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Bridgewater
country: Canada
facility: Viable Clinical Research
city: Saguenay
country: Canada
facility: Hopital Chicoutimi
city: Beijing
country: China
facility: China Japan Friendship Hospital
city: Changsha
country: China
facility: The second Xiangya Hospital of Central South University
city: Changzhou City
country: China
facility: Changzhou No 2 Peoples Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chongqing
country: China
facility: Chongqing Medical University
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Guangzhou
country: China
facility: Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical Hospital
city: Haikou
country: China
facility: Hainan General Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Jinhua
country: China
facility: Jinhua municipal central hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of NanChang University
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuxi
country: China
facility: Wuxi People s Hospital
city: Xiamen
country: China
facility: Zhongshan Hospital, Xiamen University
city: Yangzhou
country: China
facility: Yangzhou First People's Hospital
city: ZhuZhou
country: China
facility: ZhuZhou Central Hospital
city: Bjelovar
country: Croatia
facility: Opca bolnica Bjelovar
city: Split
country: Croatia
facility: University Hospital Center Split
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Brno
country: Czechia
facility: Vojenska nemocnice Brno
city: Praha 9
country: Czechia
facility: ISCARE a.s.
city: Usti nad Labem
country: Czechia
facility: Detska klinika Masarykovy nemocnice v Usti nad Labem
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Og Frederiksberg Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital, University of Copenhagen
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Silkeborg
country: Denmark
facility: Silkeborg Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: Tallinn Children's Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: AMIENS cedex 1
country: France
facility: CHU Amiens - Hopital Sud
city: Besancon
country: France
facility: CHRU De Besancon
city: Créteil
country: France
facility: Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
city: Grenoble
country: France
facility: CHU Grenoble
city: Marseille
country: France
facility: Hopital Nord Marseille
city: Nantes
country: France
facility: CHU de Nantes hotel Dieu
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Pare
city: Nice
country: France
facility: CHU de Nice Hopital de l Archet
city: Paris
country: France
facility: Hopital Saint Louis - Service de Gastro-Entérologie, 1 Avenue Claude Vellefaux
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rennes
country: France
facility: CHRU Hopital de Pontchaillou
city: Saint-Brieuc
country: France
facility: Hôpital Yves Le Foll
city: Saint-Etienne
country: France
facility: Centre hospitalier universitaire de St Etienne
city: Toulouse
country: France
facility: CHU Rangueil
city: Vandoeuvre les Nancy
country: France
facility: CHRU Nancy Brabois
city: Berlin-Karlshorst
country: Germany
facility: Gastroenterologische Spezialpraxis - Berlin-Karlshorst
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Berlin
country: Germany
facility: Praxis Für Gastroenteroligie
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede Mitte
city: Dachau
country: Germany
facility: Medizinisches Versorgungszentrum (MVZ) Dachau
city: Dresden
country: Germany
facility: University Hospital Dresden
city: Duisburg
country: Germany
facility: MVZ Sanaklinikum Duisburg
city: Erlangen
country: Germany
facility: Universitaetsklinik Erlangen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Frankfurt/Main
country: Germany
facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
city: Frankfurt
country: Germany
facility: JWG-University Hospital
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Fulda
country: Germany
facility: Klinikum Fulda - Tumorklinik - Germany
city: Haag
country: Germany
facility: Curiositas ad Sanum Studien und Beratungs GmBH
city: Halle Saale
country: Germany
facility: Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk
city: Halle
country: Germany
facility: BSF Studiengesellschaft
city: Hamburg
country: Germany
facility: CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Jerichow
country: Germany
facility: Praxisgemeinschaft Jerichow
city: Kassel
country: Germany
facility: Gastroenterologie Opernstrasse
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein Kiel
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Kalk
city: Leipzig
country: Germany
facility: Eugastro GmbH
city: Lueneburg
country: Germany
facility: Staedtisches Klinikum Lueneburg
city: Mannheim
country: Germany
facility: Medizinische Fakultät Mannheim der Universität Heidelberg
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Munich
country: Germany
facility: Klinikum der Universitaet Muenchen
city: Munster
country: Germany
facility: Universitatsklinikum Munster
city: Münster
country: Germany
facility: MVZ Portal 10
city: Nordhausen
country: Germany
facility: Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
city: Nürtingen
country: Germany
facility: Medius Klinik Nürtingen
city: Pforzheim
country: Germany
facility: Siloah St Trudpert Klinikum
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock
city: Saarbrücken
country: Germany
facility: Zentrum für Gastroenterologie Saar MVZ GmbH
city: Tübingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Würzburg
country: Germany
facility: Universitatsklinikum Wurzburg
city: Athens
country: Greece
facility: General Hospital of Athens 'Ippokrateion'
city: Athens
country: Greece
facility: Sotiria General State Hospital of Chest Diseases
city: Thessaloniki
country: Greece
facility: Hippokration Hospital
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Semmelweis Egyetem I.Belgyogyaszati Klinika
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
city: Ahmedabad
country: India
facility: ICON Hospital Orchid Medi services and Research Private Limited
city: Bengaluru
country: India
facility: M S Ramaiah Medical College and Hospital
city: Bhubaneswar
country: India
facility: Siksha O Anusandhan University - Institute of Medical Scienc
city: Chennai
country: India
facility: Srm Institutes For Medical Science (Sims)
city: Gurugram
country: India
facility: Fortis Memorial Research Institute
city: Hyderabad
country: India
facility: Asian Institute Of Gastroenterology
city: Hyderabad
country: India
facility: Yashoda Super Speciality Hospitals
city: Mumbai
country: India
facility: P D Hinduja National Hospital and Medical Research Center
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: Secunderabad
country: India
facility: Yashoda Super Speciality Hospitals
city: Surat
country: India
facility: Surat Institute of Digestive Sciences Hospitals
city: Surat
country: India
facility: Gujarat Gastro and Vascular Hospital
city: Afula
country: Israel
facility: Haemek Medical Center - Afula
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Med Ctr Beilinson Hosp
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Tzrifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Bari
country: Italy
facility: Università degli Studi di Bari
city: Catania
country: Italy
facility: A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale
city: Messina
country: Italy
facility: AOU Policlinico G.Martino
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Monopoli
country: Italy
facility: Ospedale Specializzato in Gastroenterologia Saverio de Bellis
city: Monserrato
country: Italy
facility: Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Negrar ( Ve)
country: Italy
facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
city: Palermo
country: Italy
facility: Ospedale Villa Sofia-Cervello
city: Roma
country: Italy
facility: Catholic University of Sacred Hearth
city: Rozzano
country: Italy
facility: IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
city: Torino
country: Italy
facility: Ospedale Molinette, AO Città della Salute e della Scienza di
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
city: Bunkyo Ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
city: Hachioji
country: Japan
facility: Tokai University Hachioji Hospital
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Hirosaki
country: Japan
facility: National Hospital Organization Hirosaki General Medical Center
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Hitachi
country: Japan
facility: Hitachi General Hospital
city: Hukuoka
country: Japan
facility: Hospital of the University of Occupational and Enviromental Health
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima IBD Gastroenterology Clinic
city: Kamakura
country: Japan
facility: Ofuna Chuo Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
city: Kawagoe
country: Japan
facility: Saitama Medical University Saitama Medical Center
city: Kitakyushu
country: Japan
facility: Kyushu Rosai Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Mitaka
country: Japan
facility: Kyorin University Hospital
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
city: Nagaoka
country: Japan
facility: Nagaoka Red Cross Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical And Dental Hospital
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Kinshukai Infusion Clinic
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: Japan Community Health Care Organization Osaka Hospital
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
city: Saga-shi
country: Japan
facility: Saga University Hospital
city: Saitama
country: Japan
facility: Tokitokai Tokito Clinic Coloproctology Center
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Sapporo
country: Japan
facility: Sapporo Tokushukai Hospital
city: Sapporo
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Shinjuku ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Shinjuku-Ku
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Sumida ku
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital
city: Takamatsu
country: Japan
facility: Takamatsu Red Cross Hospital
city: Tokyo
country: Japan
facility: The Jikei University Hospital
city: Tokyo
country: Japan
facility: Kitasato University Kitasato Institute Hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Toyota
country: Japan
facility: Ieda Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Amman
country: Jordan
facility: Jordan University Hospital
city: Amman
country: Jordan
facility: Abdali Hospital
city: Irbid
country: Jordan
facility: Irbid Specialty Hospital
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun university hospital
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St.Mary's Hospital
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
city: Ampang
country: Malaysia
facility: Hospital Ampang
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Universiteit van Amsterdam
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Lower Hutt
country: New Zealand
facility: Hutt Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Alesund
country: Norway
facility: Alesund sjukehus
city: Gjettum
country: Norway
facility: Vestre Viken HF Baerum Sykehus
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus
city: Oslo
country: Norway
facility: Oslo University Hospital HF Ulleval sykehus
city: Tromso
country: Norway
facility: Universitetssykehuset Nord-Norge HF
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Centrum Medyczne Promed
city: Lodz
country: Poland
facility: AmiCare Centrum Medyczne
city: Lublin
country: Poland
facility: Gastromed ZOZ
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Olsztynie
city: Poznan
country: Poland
facility: Synexus Polska Sp z o o
city: Poznan
country: Poland
facility: Twoja Przychodnia
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Sopot
country: Poland
facility: Endoskopia Sp z o.o.
city: Szczecin
country: Poland
facility: Sonomed Sp. z o.o.
city: Torun
country: Poland
facility: GASTROMED Sp. z o.o.
city: Warszawa
country: Poland
facility: Centrum Zdrowia Matki Dziecka i Mlodziezy
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Mswia
city: Warszawa
country: Poland
facility: Reumatika-Centrum Reumatologii, NZOZ
city: Warszawa
country: Poland
facility: NZOZ Vivamed
city: Warszawa
country: Poland
facility: Bodyclinic Sp. z o.o. sp. k
city: Wloclawek
country: Poland
facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
city: Wroclaw
country: Poland
facility: Melita Medical Sp. z o.o.
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Zamosc
country: Poland
facility: ETG Zamosc
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria
city: Portimao
country: Portugal
facility: Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
city: Porto
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia
city: Santa Maria da Feira
country: Portugal
facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: KL Ling Gastroenterology and Liver Clinic
city: Singapore
country: Singapore
facility: Gi Associates Gastroenterology
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Celje
country: Slovenia
facility: Splosna bolnisnica Celje
city: Ljubljana
country: Slovenia
facility: Univerzitetni klinicni center Ljubljana
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials Lakeview Hospital
city: Cape Town
country: South Africa
facility: Mediclinic Panorama
city: Cape Town
country: South Africa
facility: Inspired GI Care
city: Cape Town
country: South Africa
facility: Clinical Research Centre University of Cape Town
city: Cape Town
country: South Africa
facility: Groote Schur Hospital
city: Durban
country: South Africa
facility: Hillcrest private
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Pamplona
country: Spain
facility: Hosp. de Navarra
city: Pontevedra
country: Spain
facility: Hosp. Montecelo
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Torrejón de Ardoz
country: Spain
facility: Hosp. Univ. de Torrejon
city: Orebro
country: Sweden
facility: Universitetssjukhuset Orebro
city: Solna
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Ersta sjukhus
city: Basel
country: Switzerland
facility: Universitatsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Universitatsspital Bern
city: Bern
country: Switzerland
facility: Gastroenterologische Praxis Balsiger und Seibold
city: St. Gallen
country: Switzerland
facility: Kantonsspital St Gallen
city: Zuerich
country: Switzerland
facility: UniversitaetsSpital Zuerich
city: Changhua
country: Taiwan
facility: Chang-Hua Christian Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: High Wycombe
country: United Kingdom
facility: Velocity Clinical Research
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
city: London
country: United Kingdom
facility: St George's Healthcare NHS Trust
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Wolverhampton.
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: