En undersøgelse af kombinationsterapi med Guselkumab og Golimumab hos deltagere med moderat til svært aktiv Crohns sygdom (DUET-CD)
2. november 2026 opdateret af: Janssen Research & Development, LLC
En fase 2b randomiseret, dobbeltblind, aktiv og placebokontrolleret, parallelgruppe, multicenterundersøgelse til evaluering af effektiviteten og sikkerheden af induktions- og vedligeholdelseskombinationsterapi med Guselkumab og Golimumab hos deltagere med moderat til svær aktiv Crohns sygdom
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
Studieoversigt
Status
Status
Aktiv, ikke rekrutterende
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
703
Fase
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Adelaide, Australien, 5011
- The Queen Elizabeth Hospital
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Box Hill, Australien, 3128
- Box Hill Hospital
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Clayton, Australien, 3168
- Monash Health, Monash Medical Centre
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Footscray, Australien, 3011
- Western Health
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Melbourne, Australien, 3002
- St Vincent's hospital
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Newtown, Australien, 2042
- Royal Prince Alfred Hospital
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North Terrace, Australien, 5000
- Royal Adelaide Hospital
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Parkville, Australien, 3050
- Royal Melbourne Hospital
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Penrith, Australien, 2747
- Nepean Hospital
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South Brisbane, Australien, 4101
- Mater Hospital Brisbane Inflammatory Bowel Diseases
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Antwerp, Belgien, 2018
- GZA Ziekenhuizen
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Bruges, Belgien, 8000
- Algemeen Ziekenhuis Sint-Jan
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Brussels, Belgien, 1200
- Cliniques Universitaires Saint Luc
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Ghent, Belgien, 9000
- AZ Maria Middelares
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Leuven, Belgien, 3000
- UZ Leuven
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Liège, Belgien, 4000
- CHU de Liege
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Liège, Belgien, 4000
- CHC MontLegia
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Mechelen, Belgien, 2800
- Az Sint-Maarten
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Roeselare, Belgien, 8800
- Algemeen Ziekenhuis Delta
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Sint-Niklaas, Belgien
- Vitaz
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Belo Horizonte - MG, Brasilien, 30130-100
- Hospital Das Clinicas Da Ufmg
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Botucatu, Brasilien, 18608-025
- Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
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Brasília, Brasilien, 72145 450
- Chronos Clinica Medica Ltda
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Brasília, Brasilien, 71.681-603
- Impar Servicos Hospitalares S/A - Hospital Brasilia
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Curitiba, Brasilien, 80430-180
- Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica
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Jaú, Brasilien, 17201-130
- Centro de Estudos Clínicos do Interior Paulista - CECIP
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Natal, Brasilien, 59062 000
- Liga Norte Riograndense Contra O Cancer
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Porto Alegre, Brasilien, 90035-003
- Hospital das Clinicas de Porto Alegre
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Porto Alegre, Brasilien, 90035-001
- Associacao Hospitalar Moinhos de Vento
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Porto Alegre, Brasilien, 90430-001
- NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Porto Alegre, Brasilien, 90020 090
- Irmandade da Santa Casa de Misericordia de Porto Alegre
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Ribeirão Preto, Brasilien, 14048-900
- Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
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Rio de Janeiro, Brasilien, 21941-913
- Universidade Federal do Rio de Janeiro - Faculdade de Medicina
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Santo André, Brasilien, 09080-110
- Pesquisare Saude
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Santos, Brasilien, 11075-101
- Irmandade da Santa Casa da Misericórdia de Santos
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São José do Rio Preto, Brasilien, 15015-110
- Kaiser Hospta
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São Paulo, Brasilien, 05003-090
- BR Trials
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São Paulo, Brasilien, 04502-001
- Instituto D Or de Pesquisa e Ensino IDOR
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São Paulo, Brasilien, 04039-004
- Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
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São Paulo, Brasilien, 04543-011
- Hepatogastro
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São Paulo, Brasilien, 01409 902
- Hospital Nove de Julho
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São Paulo, Brasilien, 01228 000
- CPQuali Pesquisa Clinica LTDA ME
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São Paulo, Brasilien, 01228-200
- CPCLIN - Centro de Pesquisas Clínicas
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Sofia, Bulgarien, 1431
- UMHAT 'Aleksandrovska' EAD
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Sofia, Bulgarien, 1527
- MHAT Tzaritza Joanna
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Bridgewater, Canada, B4V 3N2
- Viable Clinical Research
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Saguenay, Canada, G7H3C3
- Hopital Chicoutimi
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Alberta
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Calgary, Alberta, Canada, T2N4N1
- Foothills Hospital
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Edmonton, Alberta, Canada, T6G 2X8
- University of Alberta Hospital
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Edmonton, Alberta, Canada, T5R 1W2
- Gastroenterology and Internal Medicine Research Institute (GIRI)
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Edmonton, Alberta, Canada, T6K 4B2
- Covenant Health/Grey Nuns hospital
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British Columbia
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New Westminster, British Columbia, Canada, V3L 3W4
- Fraser Clinical Trials Inc.
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Vancouver, British Columbia, Canada, V5Z 1M9
- The Gordon & Leslie Diamond Health Care Center
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Vancouver, British Columbia, Canada, V6Z 2K5
- GIRI Gastrointestinal Research Institute
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Vancouver, British Columbia, Canada, V7M 2H4
- The Medical Arts Health Research Group
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Victoria, British Columbia, Canada, V8P 2P5
- PerCuro Clinical Research Ltd.
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
- Winnipeg Health Sciences Centre
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Nova Scotia
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Dartmouth, Nova Scotia, Canada, B2W 6L4
- Viable Clinical Research 1
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Health Authority
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- Barrie GI Associates
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre
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Toronto, Ontario, Canada, M6A 3B4
- Toronto Immune and Digestive Health Institute Inc
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
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Montreal, Quebec, Canada, H3G 1A4
- McGill University - Health Centre - Montreal General Hospital
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Saint-Jérôme, Quebec, Canada, J7Z 5T3
- St. Jerome Medical Research
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Ville Mont-Royal, Quebec, Canada, H3P-3E5
- CMIIM, Centre médical L'Enjeu
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 0W8
- Royal University Hospital
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Aarhus, Danmark
- Aarhus University Hospital
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Copenhagen, Danmark, 2400
- Bispebjerg Og Frederiksberg Hospital
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Herlev, Danmark, 2730
- Herlev Hospital, University of Copenhagen
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Odense, Danmark, 5000
- Odense Universitetshospital
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Silkeborg, Danmark, 8600
- Silkeborg Hospital
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Belfast, Det Forenede Kongerige, BT12 6BA
- Royal Victoria Hospital
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Birmingham, Det Forenede Kongerige, B15 2TH
- University Hospitals Birmingham NHS Foundation Trust
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Cambridge, Det Forenede Kongerige, CB2 0QQ
- Addenbrooke's Hospital
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Glasgow, Det Forenede Kongerige, G4 0SF
- Glasgow Royal Infirmary
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Glasgow, Det Forenede Kongerige, G51 4TF
- Queen Elizabeth University Hospital
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High Wycombe, Det Forenede Kongerige, HP112QW
- Velocity Clinical Research
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London, Det Forenede Kongerige, E111NR
- Whipps Cross University Hospital
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London, Det Forenede Kongerige, SW19 0QT
- St Georges Healthcare NHS Trust
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Oxford, Det Forenede Kongerige, OX3 9DU
- John Radcliffe Hospital
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Wolverhampton, Det Forenede Kongerige, WV10 0QP
- New Cross Hospital
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Tallinn, Estland, 10617
- West Tallinn Central Hospital
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Tallinn, Estland, 13419
- Tallinn Children's Hospital
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Tartu, Estland, 50406
- Tartu University Hospital
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama Liver Center
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Arizona
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Tucson, Arizona, Forenede Stater, 85715
- Del Sol Research Management, LLC
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Moore Clinical Trials, LLC
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California
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Apple Valley, California, Forenede Stater, 92307
- Om Research LLC
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Arcadia, California, Forenede Stater, 91006
- Valley Gastroenterology Medical Group
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Coronado, California, Forenede Stater, 92118
- Southern California Research Center
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Lancaster, California, Forenede Stater, 93534
- Desert Gastroenterology Associates
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Los Angeles, California, Forenede Stater, 90095
- UCLA
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Los Angeles, California, Forenede Stater, 90048
- Cedars Sinai Medical Center
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Newport Beach, California, Forenede Stater, 92658
- Hoag Memorial Hospital
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Orange, California, Forenede Stater, 92868
- UCI Irvine Medical Center
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San Diego, California, Forenede Stater, 92123
- Medical Associates Research Group, Inc.
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San Francisco, California, Forenede Stater, 94115
- University of California San Francisco
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado
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Connecticut
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Hamden, Connecticut, Forenede Stater, 06518
- Medical Research Center of Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Yale University School Of Medicine
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20007
- MedStar Georgetown University Hospital
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Florida
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Coconut Creek, Florida, Forenede Stater, 33066
- Pioneer Research Solutions Inc.
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Homestead, Florida, Forenede Stater, 33032
- Homestead Associates in Research Inc
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Kissimmee, Florida, Forenede Stater, 34741
- Osceola Mental Health D/B/A Park Place Behavioral Health Care
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Lakewood Rch, Florida, Forenede Stater, 34211
- Florida Research Center Inc.
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Miami, Florida, Forenede Stater, 33136
- University of Miami Hospital
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Naples, Florida, Forenede Stater, 34102
- Gastroenterology Group Of Naples
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Orlando, Florida, Forenede Stater, 32808
- Omega Research Consultants
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St. Petersburg, Florida, Forenede Stater, 33705
- Synergy Clinical Research
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Tampa, Florida, Forenede Stater, 33609
- GCP Clinical Research
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342
- Atlanta Gastroenterology Associates
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Atlanta, Georgia, Forenede Stater, 30342
- University of Mississippi Medical Center
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Macon, Georgia, Forenede Stater, 31201
- Gastroenterolgy Associates of Central GA
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Marietta, Georgia, Forenede Stater, 30060
- Gastrointestinal Specialists of Georgia
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- IU Health University Hospital
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New Albany, Indiana, Forenede Stater, 47150
- Gastroenterology of Southern Indiana
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Kansas
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Topeka, Kansas, Forenede Stater, 66606
- Cotton O'Neil Digestive Health Center
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Wichita, Kansas, Forenede Stater, 67208
- Ascension via Christi Research
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Wichita, Kansas, Forenede Stater, 67214-3124
- Univ. of KS School of Med
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Kentucky
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Crestview Hills, Kentucky, Forenede Stater, 41017
- Tri-State Gastroenterology Assoc
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Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- Jewish Hospital
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Louisiana
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Lafayette, Louisiana, Forenede Stater, 70503
- Gastroenterology Clinic of Acadiana
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Marrero, Louisiana, Forenede Stater, 70072
- Tandem Clinical Research
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New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Medical Center
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Maryland
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Chevy Chase, Maryland, Forenede Stater, 20815
- Chevy Chase Clinical Research
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215-5400
- Lahey Hospital & Medical Center
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Chestnut Hill, Massachusetts, Forenede Stater, 02467
- Brigham And Women's Hospital
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South Dartmouth, Massachusetts, Forenede Stater, 02747
- FC Research, LLC
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Michigan
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Livonia, Michigan, Forenede Stater, 48152
- Detroit Clinical Research Center
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Ypsilanti, Michigan, Forenede Stater, 48197
- Huron Gastroenterology Associates Center for Digestive Care
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Mississippi
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Flowood, Mississippi, Forenede Stater, 39232
- Gastrointestinal Associates LLP
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Washington University
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89113
- Las Vegas Medical Research
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Las Vegas, Nevada, Forenede Stater, 89148
- Care Access Las Vegas
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth Hitchcock
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New York
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Great Neck, New York, Forenede Stater, 11021
- Northwell Health
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Jackson Heights, New York, Forenede Stater, 11372
- A1 Clinical Research
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New York, New York, Forenede Stater, 10021
- Weill Cornell Medical College
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New York, New York, Forenede Stater, 10075
- Lenox Hill Hospital
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Utica, New York, Forenede Stater, 13502-6313
- Mohawk Valley Endoscopy Center
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599-7080
- University of North Carolina
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Charlotte, North Carolina, Forenede Stater, 28210
- Tryon Medical Group
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Winston-Salem, North Carolina, Forenede Stater, 27103
- PMG Research of Winston-Salem
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals Case Medical Center
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Cleveland, Ohio, Forenede Stater, 44195-6501
- Cleveland Clinic
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Westlake, Ohio, Forenede Stater, 44145
- Northshore Gastroenterology Research, LLC
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Oregon
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Portland, Oregon, Forenede Stater, 97220-9428
- The Oregon Clinic
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Pennsylvania
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Harrisburg, Pennsylvania, Forenede Stater, 17110-3673
- Susquehanna Gastroenterology Associates
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania - Perelman School of Medicine
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Smithfield, Pennsylvania, Forenede Stater, 15478
- Frontier Clinical Research
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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Rock Hill, South Carolina, Forenede Stater, 29732
- Digestive Disease Associates
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- Saint Francis Hospital
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Hixson, Tennessee, Forenede Stater, 37343
- Galen Medical Group
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Johnson City, Tennessee, Forenede Stater, 37604
- Etsu Quillen College Of Medicine
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Nashville, Tennessee, Forenede Stater, 37067
- Vanderbilt University Medical Center
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Texas
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Austin, Texas, Forenede Stater, 78750
- Amel Med LLC Research
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Dallas, Texas, Forenede Stater, 75390-9063
- UT Southwestern Medical Center
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Dallas, Texas, Forenede Stater, 75242
- Baylor University Medical Center
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Houston, Texas, Forenede Stater, 77034
- Accurate Clinical Research
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San Antonio, Texas, Forenede Stater, 78229
- Gastroenterology Clinic Of San Antonio P A
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Southlake, Texas, Forenede Stater, 76092
- Texas Digestive Disease Consultants
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Tyler, Texas, Forenede Stater, 75701
- Digestive Health Specialists
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Utah
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Ogden, Utah, Forenede Stater, 84403
- Care Access Research, Ogden
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Salt Lake City, Utah, Forenede Stater, 84124
- Care Access Research- Salt Lake City
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia
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Richmond, Virginia, Forenede Stater, 23249
- Hunter Holmes McGuire Veterans Affairs Medical Center
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Washington
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Bellevue, Washington, Forenede Stater, 98004
- Washington Gastroenterology, PLLC
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Seattle, Washington, Forenede Stater, 98104
- Swedish Medical Center
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Seattle, Washington, Forenede Stater, 98195
- University of Washington Digestive Disease Center
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Tacoma, Washington, Forenede Stater, 98405
- Digestive Health Specialists 1
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West Virginia
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Huntington, West Virginia, Forenede Stater, 25701
- Marshall Health Clinical Research Center
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Amiens, Frankrig, 80054
- CHU Amiens - Hopital Sud
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Besançon, Frankrig, 25030
- CHRU De Besancon
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Créteil, Frankrig, 94010
- Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
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Grenoble, Frankrig, 38700
- CHU Grenoble
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Marseille, Frankrig, 13915
- Hopital Nord Marseille
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Nantes, Frankrig, 44093
- CHU de Nantes hotel Dieu
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Neuilly-sur-Seine, Frankrig, 92200
- Clinique Ambroise Pare
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Nice, Frankrig, 06202
- CHU de Nice Hopital de l Archet
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Paris, Frankrig, 75010
- Hopital Saint Louis - Service de Gastro-Entérologie, 1 Avenue Claude Vellefaux
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Pierre-Bénite, Frankrig, 69495
- Centre Hospitalier Lyon Sud
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Rennes, Frankrig, 35033
- CHRU Hopital de Pontchaillou
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Saint-Brieuc, Frankrig, 22027
- Hôpital Yves Le Foll
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Saint-Etienne, Frankrig, 42055
- Centre hospitalier universitaire de St Etienne
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Toulouse, Frankrig, 31059
- CHU Rangueil
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Vandœuvre-lès-Nancy, Frankrig, 54511
- CHRU Nancy Brabois
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Athens, Grækenland, 115 27
- Sotiria General State Hospital of Chest Diseases
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Athens, Grækenland, 115 27
- General Hospital of Athens 'Ippokrateion'
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Thessaloniki, Grækenland, 54642
- Hippokration Hospital
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Amsterdam, Holland, 1105 AZ
- Academisch Medisch Centrum Universiteit van Amsterdam
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Dordrecht, Holland, 3318 AT
- Albert Schweitzer Ziekenhuis
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Leiden, Holland, 2333 ZA
- Leiden University Medical Center
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Maastricht, Holland, 6229 HX
- Maastricht Universitair Medisch Centrum
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Rotterdam, Holland, 3015 GD
- Erasmus MC
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Utrecht, Holland, 3508 GA
- UMC Utrecht
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Ahmedabad, Indien, 380009
- ICON Hospital Orchid Medi services and Research Private Limited
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Bengaluru, Indien, 560054
- M S Ramaiah Medical College and Hospital
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Bhubaneswar, Indien, 751030
- Siksha O Anusandhan University - Institute of Medical Scienc
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Chennai, Indien, 600026
- Srm Institutes For Medical Science (Sims)
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Gūrgaon, Indien, 122002
- Fortis Memorial Research Institute
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Hyderabad, Indien, 500082
- Yashoda Super Speciality Hospitals 1
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Hyderabad, Indien, 500082
- Asian Institute Of Gastroenterology
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Mumbai, Indien, 400016
- P D Hinduja National Hospital and Medical Research Center
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New Delhi, Indien, 110029
- All India Institute of Medical Sciences
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Secunderabad, Indien, 500003
- Yashoda Super Speciality Hospitals
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Surat, Indien, 395002
- Surat Institute of Digestive Sciences Hospitals
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Surat, Indien, 395009
- Gujarat Gastro and Vascular Hospital
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-
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Afula, Israel, 1834111
- Haemek Medical Center - Afula
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Haifa, Israel, 31096
- Rambam Medical Center
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Haifa, Israel, 31048
- Bnai Zion Medical Center
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
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Jerusalem, Israel, 91120
- Hadassah Hebrew University Medical Center
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Petah Tikva, Israel, 4941492
- Rabin Med Ctr Beilinson Hosp
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Rehovot, Israel, 76100
- Kaplan Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center
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Tel HaShomer, Israel, 52621
- The Chaim Sheba Medical Center
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Tzrifin, Israel, 70300
- Assaf Harofeh Medical Center
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-
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Bari, Italien, 70124
- Università degli Studi di Bari
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Catania, Italien, 95126
- A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale
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Messina, Italien, 98125
- AOU Policlinico G.Martino
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Milan, Italien, 20132
- Ospedale San Raffaele
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Monopoli, Italien, 70043
- Ospedale Specializzato in Gastroenterologia Saverio de Bellis
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Monserrato, Italien, 09042
- Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
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Monza, Italien, 20090
- Azienda Ospedaliera San Gerardo
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Negrar ( Ve), Italien, 37024
- Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
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Palermo, Italien, 90146
- Ospedale Villa Sofia-Cervello
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Roma, Italien, 00168
- Catholic University of Sacred Hearth
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Rozzano, Italien, 20089
- IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
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Torino, Italien, 10126
- Ospedale Molinette, AO Città della Salute e della Scienza di
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-
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Asahikawa, Japan, 078-8510
- Asahikawa Medical University Hospital
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Bunkyō City, Japan, 113 8519
- Tokyo Medical and Dental University Hospital
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Chikushino-shi, Japan, 818-8502
- Fukuoka University Chikushi Hospital
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Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
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Fukuoka, Japan, 807-8555
- Hospital of the University of Occupational and Environmental Health
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Hachiōji, Japan, 192-0032
- Tokai University Hachioji Hospital
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Hamamatsu, Japan, 431-3192
- Hamamatsu University Hospital
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Hirosaki, Japan, 036-8563
- Hirosaki University Hospital
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Hirosaki, Japan, 036-8545
- National Hospital Organization Hirosaki General Medical Center
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Hitachi, Japan, 317-0077
- Hitachi General Hospital
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Hyōgo, Japan, 663-8501
- Hyogo Medical University Hospital
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Kagoshima, Japan, 890-8520
- Kagoshima University Hospital
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Kagoshima, Japan, 892-0843
- Kagoshima IBD Gastroenterology Clinic
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Kamakura, Japan, 247-0056
- Ofuna Chuo Hospital
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Kanazawa, Japan, 9208641
- Kanazawa University Hospital
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Kashiwa, Japan, 277-0871
- Tsujinaka Hospital Kashiwanoha
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Kawagoe, Japan, 350-8550
- Saitama Medical University Saitama Medical Center
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Kitakyushu, Japan, 800-0296
- Kyushu Rosai Hospital
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Kobe, Japan, 650-0017
- Kobe University Hospital
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Kumamoto, Japan, 861-8520
- Japanese Red Cross Kumamoto Hospital
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Kurume, Japan, 830-0011
- Kurume University Hospital
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Kyoto, Japan, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Mitaka, Japan, 181-8611
- Kyorin University Hospital
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Morioka, Japan, 020-8505
- Iwate Medical University Hospital
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Nagaoka, Japan, 940-2085
- Nagaoka Red Cross Hospital
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Nagasaki, Japan, 852-8501
- Nagasaki University Hospital
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Nagoya, Japan, 466 8560
- Nagoya University Hospital
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Niigata, Japan, 951-8520
- Niigata University Medical And Dental Hospital
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Okayama, Japan, 700-8558
- Okayama University Hospital
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Osaka, Japan, 545-8586
- Osaka City University Hospital
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Osaka, Japan, 530-0011
- Kinshukai Infusion Clinic
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Osaka, Japan, 553-0003
- Japan Community Health Care Organization Osaka Hospital
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Saga, Japan, 849-0937
- Saga University Hospital
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Saitama, Japan, 336-0963
- Tokitokai Tokito Clinic Coloproctology Center
-
Sakura, Japan, 285-8741
- Toho University Sakura Medical Center
-
Sapporo, Japan, 065-0033
- Sapporo Higashi Tokushukai Hospital
-
Sapporo, Japan, 004-0041
- Sapporo Tokushukai Hospital
-
Sapporo, Japan, 060-0033
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
-
Sapporo, Japan, 060-8556
- Sapporo Medical University Hospital
-
Sendai, Japan, 980-8574
- Tohoku University Hospital
-
Shimotsuga-gun, Japan, 321-0293
- Dokkyo Medical University Hospital
-
Shimotsuke, Japan, 329-0498
- Jichi Medical University Hospital
-
Shinjuku Ku, Japan, 162 8655
- Center Hospital of the National Center for Global Health and Medicine
-
Shinjuku-Ku, Japan, 162-8666
- Tokyo Women's Medical University Hospital
-
Sumida Ku, Japan, 130 8575
- Tokyo Metropolitan Bokutoh Hospital
-
Takamatsu, Japan, 760-0017
- Takamatsu Red Cross Hospital
-
Tokyo, Japan, 108-8642
- Kitasato University Kitasato Institute Hospital
-
Tokyo, Japan, 105 8471
- The Jikei University Hospital
-
Toyama, Japan, 9308550
- Toyama Prefectural Central Hospital
-
Toyota, Japan, 470-1219
- Ieda Hospital
-
Tsu, Japan, 514-8507
- Mie University Hospital
-
Yokohama, Japan, 232 0024
- Yokohama City University Medical Center
-
Ōtsu, Japan, 520-2192
- Shiga University of Medical Science Hospital
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-
-
-
-
Amman, Jordan, 11942
- Jordan University Hospital
-
Amman, Jordan
- Abdali Hospital
-
Irbid, Jordan, 22110
- King Abdullah University Hospital
-
Irbid, Jordan, 21110
- Irbid Specialty Hospital
-
-
-
-
-
Beijing, Kina, 100029
- China Japan Friendship Hospital
-
Changsha, Kina, 200120
- The second Xiangya Hospital of Central South University
-
Changzhou, Kina, 213004
- Changzhou No 2 Peoples Hospital
-
Chengdu, Kina, 610041
- West China Hospital Sichuan University
-
Chongqing, Kina, 400013
- Chongqing Medical University
-
Foshan, Kina, 528010
- The First People's Hospital of Foshan
-
Guangzhou, Kina, 510180
- Guangzhou First Municipal People's Hospital
-
Guangzhou, Kina, 510515
- Nanfang Hospital of Southern Medical Hospital
-
Guangzhou, Kina, 510000
- Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
-
Haikou, Kina, 570311
- Hainan General Hospital
-
Hangzhou, Kina, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
-
Jinhua, Kina, 321000
- Jinhua municipal central hospital
-
Nanchang, Kina, 330006
- The First Affiliated Hospital of NanChang University
-
Nanjing, Kina, 210008
- Nanjing Drum Tower Hospital
-
Nanjing, Kina, 210000
- Zhongda Hospital Southeast University
-
Shanghai, Kina, 200120
- Shanghai East Hospital
-
Shanghai, Kina
- Ruijin Hospital Shanghai Jiao Tong University
-
Wuhan, Kina, 430014
- The Central Hospital of Wuhan
-
Wuhan, Kina, 430060
- Renmin Hospital of Wuhan University
-
Wuhan, Kina, 430022
- Wuhan Union Hospital
-
Wuxi, Kina, 214023
- Wuxi People s Hospital
-
Xiamen, Kina, 361004
- Zhongshan Hospital, Xiamen University
-
Yangzhou, Kina, 225001
- Yangzhou First People's Hospital
-
Zhuzhou, Kina, 412007
- ZhuZhou Central Hospital
-
-
-
-
-
Bjelovar, Kroatien, 43000
- Opca bolnica Bjelovar
-
Split, Kroatien, 21000
- University Hospital Center Split
-
Zagreb, Kroatien, 10000
- University Hospital Dubrava
-
-
-
-
-
Alor Star, Malaysia, 5460
- Hospital Sultanah Bahiyah
-
Ampang, Malaysia, 68000
- Hospital Ampang
-
George Town, Malaysia, 10990
- Hospital Pulau Pinang
-
Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
-
-
-
-
-
Dunedin, New Zealand, 9016
- Dunedin Hospital
-
Lower Hutt, New Zealand, 5010
- Hutt Hospital
-
Wellington, New Zealand, 6021
- Wellington Hospital
-
-
-
-
-
Gjettum, Norge, 1346
- Vestre Viken HF Baerum Sykehus
-
Lørenskog, Norge, 1478
- Akershus Universitetssykehus
-
Oslo, Norge, 0450
- Oslo University Hospital HF Ulleval sykehus
-
Tromsø, Norge, N-9038
- Universitetssykehuset Nord-Norge HF
-
Ålesund, Norge, 6010
- Alesund sjukehus
-
-
-
-
-
Bydgoszcz, Polen, 85-168
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
-
Krakow, Polen, 30 363
- Centrum Medyczne Plejady
-
Krakow, Polen, 31-513
- Centrum Medyczne Promed
-
Lodz, Polen, 90-644
- AmiCare Centrum Medyczne
-
Lublin, Polen, 20-583
- Gastromed ZOZ
-
Olsztyn, Polen, 10 561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
-
Poznan, Polen, 61-293
- Twoja Przychodnia
-
Poznan, Polen, 61 441
- Synexus Polska Sp z o o
-
Rzeszów, Polen, 35-326
- Centrum Medyczne Medyk
-
Sopot, Polen, 81-756
- Endoskopia Sp z o.o.
-
Szczecin, Polen, 71-685
- Sonomed Sp. z o.o.
-
Torun, Polen, 87 100
- GASTROMED Sp. z o.o.
-
Warsaw, Polen, 00 632
- Centrum Zdrowia Matki Dziecka i Mlodziezy
-
Warsaw, Polen, 03 580
- NZOZ Vivamed
-
Warsaw, Polen, 03 712
- Bodyclinic Sp. z o.o. sp. k
-
Warsaw, Polen, 02-655
- Reumatika-Centrum Reumatologii, NZOZ
-
Warsaw, Polen, 02 507
- Centralny Szpital Kliniczny Mswia
-
Wroclaw, Polen, 52-416
- Centrum Medyczne Oporow
-
Wroclaw, Polen, 50 449
- Melita Medical Sp. z o.o.
-
Włocławek, Polen, 87-800
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
-
Zamość, Polen, 22-400
- ETG Zamosc
-
-
-
-
-
Lisbon, Portugal, 1649-035
- Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria
-
Portimão, Portugal, 8500-338
- Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
-
Porto, Portugal, 4434-502
- Centro Hospitalar Vila Nova de Gaia
-
Santa Maria da Feira, Portugal, 4520-211
- Centro Hospitalar de Entre o Douro e Vouga, E.P.E
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-
-
-
-
Basel, Schweiz, 4056
- Universitatsspital Basel
-
Bern, Schweiz, 3010
- Inselspital Universitatsspital Bern
-
Bern, Schweiz, 3012
- Gastroenterologische Praxis Balsiger und Seibold
-
Sankt Gallen, Schweiz, 9007
- Kantonsspital St Gallen
-
Zurich, Schweiz, 8091
- UniversitaetsSpital Zuerich
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-
-
-
-
Singapore, Singapore, 169608
- Singapore General Hospital
-
Singapore, Singapore, 308433
- Tan Tock Seng Hospital
-
Singapore, Singapore, 228510
- KL Ling Gastroenterology and Liver Clinic
-
Singapore, Singapore, 258499
- Gi Associates Gastroenterology
-
-
-
-
-
Celje, Slovenien, 3000
- Splosna bolnisnica Celje
-
Ljubljana, Slovenien, 1000
- Univerzitetni klinicni center Ljubljana
-
-
-
-
-
Madrid, Spanien, 28046
- Hosp. Univ. La Paz
-
Pamplona, Spanien, 31008
- Hosp. de Navarra
-
Pontevedra, Spanien, 36071
- Hosp. Montecelo
-
Sabadell, Spanien, 8208
- Corporacio Sanitari Parc Tauli
-
Santander, Spanien, 39008
- Hosp. Univ. Marques de Valdecilla
-
Torrejón de Ardoz, Spanien, 28850
- Hosp. Univ. de Torrejon
-
-
-
-
-
Solna, Sverige, 17176
- Karolinska University Hospital
-
Stockholm, Sverige, 116 91
- Ersta sjukhus
-
Örebro, Sverige, 70185
- Universitetssjukhuset Orebro
-
-
-
-
-
Benoni, Sydafrika, 1501
- Worthwhile Clinical Trials Lakeview Hospital
-
Cape Town, Sydafrika, 7925
- Clinical Research Centre University of Cape Town
-
Cape Town, Sydafrika, 7925
- Groote Schur Hospital
-
Cape Town, Sydafrika, 7500
- Mediclinic Panorama
-
Cape Town, Sydafrika, 7800
- Inspired GI Care
-
Durban, Sydafrika, 3610
- Hillcrest private
-
-
-
-
-
Busan, Sydkorea, 48108
- Inje University Haeundae Paik Hospital
-
Busan, Sydkorea, 48108
- Kosin University Gospel Hospital
-
Daegu, Sydkorea, 41944
- Kyungpook National University Hospital
-
Daegu, Sydkorea, 42415
- Yeungnam University Hospital
-
Goyang-si, Sydkorea, 10326
- Dongguk University Ilsan Hospital
-
Gwangju, Sydkorea, 61453
- Chosun university hospital
-
Hwaseong-si, Sydkorea, 18450
- Hallym University Dongtan Sacred Heart Hospital
-
Seongnam-si, Sydkorea, 13620
- Seoul National University Bundang Hospital
-
Seoul, Sydkorea, 05505
- Asan Medical Center
-
Seoul, Sydkorea, 03722
- Severance Hospital Yonsei University Health System
-
Seoul, Sydkorea, 03181
- Kangbuk Samsung Hospital
-
Seoul, Sydkorea, 06273
- Gangnam Severance Hospital, Yonsei University Health System
-
Seoul, Sydkorea, 130 050
- Kyung Hee University Hospital
-
Seoul, Sydkorea, 6591
- The Catholic University of Korea Seoul St.Marys Hospital 1
-
Seoul, Sydkorea, 06591
- The Catholic University of Korea Seoul St.Mary's Hospital
-
Suwon, Sydkorea, 16499
- Ajou University Hospital
-
Suwon, Sydkorea, 16247
- The Catholic University of Korea
-
-
-
-
-
Changhua, Taiwan, 500
- Chang-Hua Christian Hospital
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
Tainan, Taiwan, 70403
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
-
-
-
-
Brno, Tjekkiet, 636 00
- Vojenska nemocnice Brno
-
Prague, Tjekkiet, 170 04
- ISCARE a.s.
-
Ústí nad Labem, Tjekkiet, 401 11
- Detska klinika Masarykovy nemocnice v Usti nad Labem
-
-
-
-
-
Berlin, Tyskland, 10117
- Charite Universitaetsmedizin Berlin - Campus Charite Mitte
-
Berlin, Tyskland, 12200
- Charite Campus Benjamin Franklin
-
Berlin, Tyskland, 14163
- Krankenhaus Waldfriede Mitte
-
Berlin, Tyskland, 10825
- Praxis Fur Gastroenteroligie
-
Cologne, Tyskland, 51103
- Evangelisches Krankenhaus Kalk
-
Dachau, Tyskland, 85221
- Medizinisches Versorgungszentrum (MVZ) Dachau
-
Dresden, Tyskland, 1307
- University Hospital Dresden
-
Duisburg, Tyskland, 47055
- MVZ Sanaklinikum Duisburg
-
Erlangen, Tyskland, 91054
- Universitaetsklinik Erlangen
-
Essen, Tyskland, 45147
- Universitaetsklinikum Essen
-
Frankfurt, Tyskland, 60590
- JWG-University Hospital
-
Frankfurt am Main, Tyskland, 60431
- Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
-
Freiburg im Breisgau, Tyskland, 79106
- Universitatsklinikum Freiburg
-
Fulda, Tyskland, 36043
- Klinikum Fulda - Tumorklinik - Germany
-
Haag, Tyskland, 83527
- Curiositas ad Sanum Studien und Beratungs GmBH
-
Halle, Tyskland, 06120
- Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk
-
Halle, Tyskland, 6108
- Studiengesellschaft Mitteldeutschland GmbH
-
Hamburg, Tyskland, 20251
- CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf
-
Hanover, Tyskland, 30625
- Medizinische Hochschule Hannover
-
Heidelberg, Tyskland, 69120
- University Hospital Heidelberg
-
Heidelberg, Tyskland, 69115
- Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd
-
Jena, Tyskland, 07747
- Universitatsklinikum Jena
-
Jerichow, Tyskland, 39319
- Praxisgemeinschaft Jerichow
-
Karlshorst, Tyskland, 10318
- Gastroenterologische Spezialpraxis - Berlin-Karlshorst
-
Kassel, Tyskland, 34117
- Gastroenterologie Opernstrasse
-
Kiel, Tyskland, 24105
- Universitatsklinikum Schleswig Holstein Kiel
-
Leipzig, Tyskland, 04103
- Eugastro GmbH
-
Lüneburg, Tyskland, 21339
- Staedtisches Klinikum Lueneburg
-
Mannheim, Tyskland, 68167
- Medizinische Fakultät Mannheim der Universität Heidelberg
-
Minden, Tyskland, 32423
- Gastroenterologische Gemeinschaftspraxis Minden
-
Munich, Tyskland, 81377
- Klinikum der Universitaet Muenchen
-
Münster, Tyskland, 48155
- MVZ Portal 10
-
Münster, Tyskland, 48149
- Universitatsklinikum Munster
-
Nordhausen, Tyskland, 99734
- Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
-
Nürtingen, Tyskland, 72622
- Medius Klinik Nurtingen
-
Pforzheim, Tyskland, 75179
- Siloah St Trudpert Klinikum
-
Regensburg, Tyskland, 93053
- Universitaetsklinikum Regensburg
-
Rostock, Tyskland, 18057
- Universitaetsmedizin Rostock
-
Saarbrücken, Tyskland, 66111
- Zentrum für Gastroenterologie Saar MVZ GmbH
-
Tübingen, Tyskland, 72076
- Universitatsklinikum Tubingen
-
Ulm, Tyskland, 89070
- Universitatsklinikum Ulm
-
Würzburg, Tyskland, 97080
- Universitatsklinikum Wurzburg
-
-
-
-
-
Budapest, Ungarn, 1036
- Obudai Egeszsegugyi Centrum Kft
-
Budapest, Ungarn, 1082
- Semmelweis Egyetem
-
Budapest, Ungarn, 1088
- Semmelweis Egyetem I.Belgyogyaszati Klinika
-
Gyöngyös, Ungarn, 3200
- Bugat Pal Korhaz
-
Szeged, Ungarn, H-6720
- Szegedi Tudomanyegyetem
-
Szombathely, Ungarn, H-9700
- Markusovszky Egyetemi Oktatokorhaz
-
-
-
-
-
Salzburg, Østrig, 5020
- Landeskrankenhaus Salzburg, Universitätsklinik f. Innere Medizin III
-
Vienna, Østrig, 1090
- Akh Wien 1
-
Vienna, Østrig, 1090
- Akh Wien
-
Wels, Østrig, 4600
- Klinikum Wels Grieskirchen
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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'
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
6
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Placebo komparator: 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. |
Placebo will be administered as subcutaneous injection. |
|
Eksperimentel: 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. |
Guselkumab will be administered as subcutaneous injection. |
|
Eksperimentel: 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. |
Golimumab will be administered as subcutaneous injection. |
|
Eksperimentel: 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. |
JNJ-78934804 will be administered subcutaneously as per defined regimen. |
|
Eksperimentel: 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. |
JNJ-78934804 will be administered subcutaneously as per defined regimen. |
|
Eksperimentel: 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. |
JNJ-78934804 will be administered subcutaneously as per defined regimen. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants with Clinical Remission at Week 48
Tidsramme: Week 48
|
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI). |
Week 48
|
|
Percentage of Participants with Endoscopic Response at Week 48
Tidsramme: Week 48
|
Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the simple endoscopic score for Crohn's disease (SES-CD), as assessed by central endoscopy reading. |
Week 48
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48
Tidsramme: Week 48
|
Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores. |
Week 48
|
|
Percentage of Participants with Endoscopic Remission at Week 48
Tidsramme: Week 48
|
Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD, as assessed by central endoscopy reading. |
Week 48
|
|
Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 48
Tidsramme: Week 48
|
Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported. |
Week 48
|
|
Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48
Tidsramme: Week 48
|
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI). |
Week 48
|
|
Secondary Comparison: Percentage of Participants with Endoscopic Response at Week 48
Tidsramme: Week 48
|
Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the SES-CD, as assessed by central endoscopy reading. |
Week 48
|
|
Percentage of Participants with Adverse Events (AEs)
Tidsramme: Up to Week 48
|
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. |
Up to Week 48
|
|
Percentage of Participants with Serious Adverse Events (SAEs)
Tidsramme: Up to Week 48
|
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important. |
Up to Week 48
|
|
Clinical Laboratory Parameters Over Time
Tidsramme: Up to Week 48
|
Clinical laboratory parameters over time will be reported. |
Up to Week 48
|
|
Vital Sign Parameters Over Time
Tidsramme: Up to Week 48
|
Vital sign parameters over time will be reported. |
Up to Week 48
|
|
Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score
Tidsramme: Up to Week 48
|
The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Worsening of suicidal ideation is defined as an increase in severity of suicidal ideation from baseline. |
Up to Week 48
|
|
Serum Concentrations of Guselkumab Over Time
Tidsramme: Up to Week 48
|
Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method. |
Up to Week 48
|
|
Serum Concentrations of Golimumab Over Time
Tidsramme: Up to Week 48
|
Serum concentrations of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method. |
Up to Week 48
|
|
Percentage of Participants with Antibodies to Guselkumab
Tidsramme: Up to Week 48
|
Percentage of participants with antibodies to guselkumab will be reported. |
Up to Week 48
|
|
Titers of Antibodies to Guselkumab
Tidsramme: Up to Week 48
|
Titers of antibodies to guselkumab will be reported. |
Up to Week 48
|
|
Percentage of Participants with Antibodies to Golimumab
Tidsramme: Up to Week 48
|
Percentage of participants with antibodies to golimumab will be reported. |
Up to Week 48
|
|
Titers of Antibodies to Golimumab
Tidsramme: Up to Week 48
|
Titers of antibodies to golimumab will be reported. |
Up to Week 48
|
|
Percentage of Participants with Neutralizing Antibodies to Guselkumab.
Tidsramme: Up to Week 48
|
Percentage of participants with neutralizing antibodies to guselkumab will be reported. |
Up to Week 48
|
|
Percentage of Participants with Neutralizing Antibodies to Golimumab
Tidsramme: Up to Week 48
|
Percentage of participants with neutralizing antibodies to golimumab will be reported. |
Up to Week 48
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
22. juli 2022
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
23. maj 2025
Studieafslutning (Anslået)
Studieafslutning
5. november 2029
Datoer for studieregistrering
Først indsendt
Først indsendt
15. februar 2022
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
15. februar 2022
Først opslået (Faktiske)
Først opslået
16. februar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
4. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2026
Sidst verificeret
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CR109178
- 2021-003314-39 (EudraCT nummer)
- 78934804CRD2001 (Anden identifikator: Janssen Research & Development, LLC)
- 2023-504741-32-00 (Registry Identifier: EUCT number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .