Uno studio sulla terapia di combinazione con Guselkumab e Golimumab nei partecipanti con malattia di Crohn da moderatamente a gravemente attiva (DUET-CD)
2 novembre 2026 aggiornato da: Janssen Research & Development, LLC
Uno studio di fase 2b randomizzato, in doppio cieco, controllato con farmaco attivo e placebo, a gruppi paralleli, multicentrico per valutare l'efficacia e la sicurezza della terapia di combinazione di induzione e mantenimento con guselkumab e golimumab nei partecipanti con malattia di Crohn da moderatamente a gravemente attiva
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
Panoramica dello studio
Stato
Stato
Attivo, non reclutante
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
Iscrizione
703
Fase
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Adelaide, Australia, 5011
- The Queen Elizabeth Hospital
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Box Hill, Australia, 3128
- Box Hill Hospital
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Clayton, Australia, 3168
- Monash Health, Monash Medical Centre
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Footscray, Australia, 3011
- Western Health
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Melbourne, Australia, 3002
- St Vincent's hospital
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Newtown, Australia, 2042
- Royal Prince Alfred Hospital
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North Terrace, Australia, 5000
- Royal Adelaide Hospital
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Parkville, Australia, 3050
- Royal Melbourne Hospital
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Penrith, Australia, 2747
- Nepean Hospital
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South Brisbane, Australia, 4101
- Mater Hospital Brisbane Inflammatory Bowel Diseases
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Salzburg, Austria, 5020
- Landeskrankenhaus Salzburg, Universitätsklinik f. Innere Medizin III
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Vienna, Austria, 1090
- Akh Wien 1
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Vienna, Austria, 1090
- Akh Wien
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Wels, Austria, 4600
- Klinikum Wels Grieskirchen
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Antwerp, Belgio, 2018
- GZA Ziekenhuizen
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Bruges, Belgio, 8000
- Algemeen Ziekenhuis Sint-Jan
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Brussels, Belgio, 1200
- Cliniques Universitaires Saint Luc
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Ghent, Belgio, 9000
- AZ Maria Middelares
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Leuven, Belgio, 3000
- UZ Leuven
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Liège, Belgio, 4000
- CHU de Liege
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Liège, Belgio, 4000
- CHC MontLegia
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Mechelen, Belgio, 2800
- Az Sint-Maarten
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Roeselare, Belgio, 8800
- Algemeen Ziekenhuis Delta
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Sint-Niklaas, Belgio
- Vitaz
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Belo Horizonte - MG, Brasile, 30130-100
- Hospital Das Clinicas Da Ufmg
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Botucatu, Brasile, 18608-025
- Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
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Brasília, Brasile, 72145 450
- Chronos Clinica Medica Ltda
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Brasília, Brasile, 71.681-603
- Impar Servicos Hospitalares S/A - Hospital Brasilia
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Curitiba, Brasile, 80430-180
- Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica
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Jaú, Brasile, 17201-130
- Centro de Estudos Clínicos do Interior Paulista - CECIP
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Natal, Brasile, 59062 000
- Liga Norte Riograndense Contra O Cancer
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Porto Alegre, Brasile, 90035-003
- Hospital das Clinicas de Porto Alegre
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Porto Alegre, Brasile, 90035-001
- Associacao Hospitalar Moinhos de Vento
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Porto Alegre, Brasile, 90430-001
- NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Porto Alegre, Brasile, 90020 090
- Irmandade da Santa Casa de Misericordia de Porto Alegre
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Ribeirão Preto, Brasile, 14048-900
- Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
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Rio de Janeiro, Brasile, 21941-913
- Universidade Federal do Rio de Janeiro - Faculdade de Medicina
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Santo André, Brasile, 09080-110
- Pesquisare Saude
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Santos, Brasile, 11075-101
- Irmandade da Santa Casa da Misericórdia de Santos
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São José do Rio Preto, Brasile, 15015-110
- Kaiser Hospta
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São Paulo, Brasile, 05003-090
- BR Trials
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São Paulo, Brasile, 04502-001
- Instituto D Or de Pesquisa e Ensino IDOR
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São Paulo, Brasile, 04039-004
- Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
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São Paulo, Brasile, 04543-011
- Hepatogastro
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São Paulo, Brasile, 01409 902
- Hospital Nove de Julho
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São Paulo, Brasile, 01228 000
- CPQuali Pesquisa Clinica LTDA ME
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São Paulo, Brasile, 01228-200
- CPCLIN - Centro de Pesquisas Clínicas
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Sofia, Bulgaria, 1431
- UMHAT 'Aleksandrovska' EAD
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Sofia, Bulgaria, 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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Brno, Cechia, 636 00
- Vojenska nemocnice Brno
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Prague, Cechia, 170 04
- ISCARE a.s.
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Ústí nad Labem, Cechia, 401 11
- Detska klinika Masarykovy nemocnice v Usti nad Labem
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Beijing, Cina, 100029
- China Japan Friendship Hospital
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Changsha, Cina, 200120
- The second Xiangya Hospital of Central South University
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Changzhou, Cina, 213004
- Changzhou No 2 Peoples Hospital
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Chengdu, Cina, 610041
- West China Hospital Sichuan University
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Chongqing, Cina, 400013
- Chongqing Medical University
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Foshan, Cina, 528010
- The First People's Hospital of Foshan
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Guangzhou, Cina, 510180
- Guangzhou First Municipal People's Hospital
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Guangzhou, Cina, 510515
- Nanfang Hospital of Southern Medical Hospital
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Guangzhou, Cina, 510000
- Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
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Haikou, Cina, 570311
- Hainan General Hospital
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Hangzhou, Cina, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Jinhua, Cina, 321000
- Jinhua municipal central hospital
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Nanchang, Cina, 330006
- The First Affiliated Hospital of NanChang University
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Nanjing, Cina, 210008
- Nanjing Drum Tower Hospital
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Nanjing, Cina, 210000
- Zhongda Hospital Southeast University
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Shanghai, Cina, 200120
- Shanghai East Hospital
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Shanghai, Cina
- Ruijin Hospital Shanghai Jiao Tong University
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Wuhan, Cina, 430014
- The Central Hospital of Wuhan
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Wuhan, Cina, 430060
- Renmin Hospital of Wuhan University
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Wuhan, Cina, 430022
- Wuhan Union Hospital
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Wuxi, Cina, 214023
- Wuxi People s Hospital
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Xiamen, Cina, 361004
- Zhongshan Hospital, Xiamen University
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Yangzhou, Cina, 225001
- Yangzhou First People's Hospital
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Zhuzhou, Cina, 412007
- ZhuZhou Central Hospital
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Busan, Corea del Sud, 48108
- Inje University Haeundae Paik Hospital
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Busan, Corea del Sud, 48108
- Kosin University Gospel Hospital
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Daegu, Corea del Sud, 41944
- Kyungpook National University Hospital
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Daegu, Corea del Sud, 42415
- Yeungnam University Hospital
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Goyang-si, Corea del Sud, 10326
- Dongguk University Ilsan Hospital
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Gwangju, Corea del Sud, 61453
- Chosun university hospital
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Hwaseong-si, Corea del Sud, 18450
- Hallym University Dongtan Sacred Heart Hospital
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Seongnam-si, Corea del Sud, 13620
- Seoul National University Bundang Hospital
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Seoul, Corea del Sud, 05505
- Asan Medical Center
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Seoul, Corea del Sud, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Corea del Sud, 03181
- Kangbuk Samsung Hospital
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Seoul, Corea del Sud, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Corea del Sud, 130 050
- Kyung Hee University Hospital
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Seoul, Corea del Sud, 6591
- The Catholic University of Korea Seoul St.Marys Hospital 1
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Seoul, Corea del Sud, 06591
- The Catholic University of Korea Seoul St.Mary's Hospital
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Suwon, Corea del Sud, 16499
- Ajou University Hospital
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Suwon, Corea del Sud, 16247
- The Catholic University of Korea
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Bjelovar, Croazia, 43000
- Opca bolnica Bjelovar
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Split, Croazia, 21000
- University Hospital Center Split
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Zagreb, Croazia, 10000
- University Hospital Dubrava
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Aarhus, Danimarca
- Aarhus University Hospital
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Copenhagen, Danimarca, 2400
- Bispebjerg Og Frederiksberg Hospital
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Herlev, Danimarca, 2730
- Herlev Hospital, University of Copenhagen
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Odense, Danimarca, 5000
- Odense Universitetshospital
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Silkeborg, Danimarca, 8600
- Silkeborg Hospital
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Tallinn, Estonia, 10617
- West Tallinn Central Hospital
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Tallinn, Estonia, 13419
- Tallinn Children's Hospital
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Tartu, Estonia, 50406
- Tartu University Hospital
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Amiens, Francia, 80054
- CHU Amiens - Hopital Sud
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Besançon, Francia, 25030
- CHRU De Besancon
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Créteil, Francia, 94010
- Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
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Grenoble, Francia, 38700
- CHU Grenoble
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Marseille, Francia, 13915
- Hopital Nord Marseille
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Nantes, Francia, 44093
- CHU de Nantes hotel Dieu
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Neuilly-sur-Seine, Francia, 92200
- Clinique Ambroise Pare
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Nice, Francia, 06202
- CHU de Nice Hopital de l Archet
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Paris, Francia, 75010
- Hopital Saint Louis - Service de Gastro-Entérologie, 1 Avenue Claude Vellefaux
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Pierre-Bénite, Francia, 69495
- Centre Hospitalier Lyon Sud
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Rennes, Francia, 35033
- CHRU Hopital de Pontchaillou
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Saint-Brieuc, Francia, 22027
- Hôpital Yves Le Foll
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Saint-Etienne, Francia, 42055
- Centre hospitalier universitaire de St Etienne
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Toulouse, Francia, 31059
- CHU Rangueil
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Vandœuvre-lès-Nancy, Francia, 54511
- CHRU Nancy Brabois
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Berlin, Germania, 10117
- Charite Universitaetsmedizin Berlin - Campus Charite Mitte
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Berlin, Germania, 12200
- Charite Campus Benjamin Franklin
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Berlin, Germania, 14163
- Krankenhaus Waldfriede Mitte
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Berlin, Germania, 10825
- Praxis Fur Gastroenteroligie
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Cologne, Germania, 51103
- Evangelisches Krankenhaus Kalk
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Dachau, Germania, 85221
- Medizinisches Versorgungszentrum (MVZ) Dachau
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Dresden, Germania, 1307
- University Hospital Dresden
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Duisburg, Germania, 47055
- MVZ Sanaklinikum Duisburg
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Erlangen, Germania, 91054
- Universitaetsklinik Erlangen
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Essen, Germania, 45147
- Universitaetsklinikum Essen
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Frankfurt, Germania, 60590
- JWG-University Hospital
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Frankfurt am Main, Germania, 60431
- Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
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Freiburg im Breisgau, Germania, 79106
- Universitatsklinikum Freiburg
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Fulda, Germania, 36043
- Klinikum Fulda - Tumorklinik - Germany
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Haag, Germania, 83527
- Curiositas ad Sanum Studien und Beratungs GmBH
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Halle, Germania, 06120
- Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk
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Halle, Germania, 6108
- Studiengesellschaft Mitteldeutschland GmbH
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Hamburg, Germania, 20251
- CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf
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Hanover, Germania, 30625
- Medizinische Hochschule Hannover
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Heidelberg, Germania, 69120
- University Hospital Heidelberg
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Heidelberg, Germania, 69115
- Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd
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Jena, Germania, 07747
- Universitatsklinikum Jena
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Jerichow, Germania, 39319
- Praxisgemeinschaft Jerichow
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Karlshorst, Germania, 10318
- Gastroenterologische Spezialpraxis - Berlin-Karlshorst
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Kassel, Germania, 34117
- Gastroenterologie Opernstrasse
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Kiel, Germania, 24105
- Universitatsklinikum Schleswig Holstein Kiel
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Leipzig, Germania, 04103
- Eugastro GmbH
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Lüneburg, Germania, 21339
- Staedtisches Klinikum Lueneburg
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Mannheim, Germania, 68167
- Medizinische Fakultät Mannheim der Universität Heidelberg
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Minden, Germania, 32423
- Gastroenterologische Gemeinschaftspraxis Minden
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Munich, Germania, 81377
- Klinikum der Universitaet Muenchen
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Münster, Germania, 48155
- MVZ Portal 10
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Münster, Germania, 48149
- Universitatsklinikum Munster
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Nordhausen, Germania, 99734
- Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
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Nürtingen, Germania, 72622
- Medius Klinik Nurtingen
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Pforzheim, Germania, 75179
- Siloah St Trudpert Klinikum
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Regensburg, Germania, 93053
- Universitaetsklinikum Regensburg
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Rostock, Germania, 18057
- Universitaetsmedizin Rostock
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Saarbrücken, Germania, 66111
- Zentrum für Gastroenterologie Saar MVZ GmbH
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Tübingen, Germania, 72076
- Universitatsklinikum Tubingen
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Ulm, Germania, 89070
- Universitatsklinikum Ulm
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Würzburg, Germania, 97080
- Universitatsklinikum Wurzburg
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Asahikawa, Giappone, 078-8510
- Asahikawa Medical University Hospital
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Bunkyō City, Giappone, 113 8519
- Tokyo Medical and Dental University Hospital
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Chikushino-shi, Giappone, 818-8502
- Fukuoka University Chikushi Hospital
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Fukuoka, Giappone, 814-0180
- Fukuoka University Hospital
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Fukuoka, Giappone, 807-8555
- Hospital of the University of Occupational and Environmental Health
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Hachiōji, Giappone, 192-0032
- Tokai University Hachioji Hospital
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Hamamatsu, Giappone, 431-3192
- Hamamatsu University Hospital
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Hirosaki, Giappone, 036-8563
- Hirosaki University Hospital
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Hirosaki, Giappone, 036-8545
- National Hospital Organization Hirosaki General Medical Center
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Hitachi, Giappone, 317-0077
- Hitachi General Hospital
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Hyōgo, Giappone, 663-8501
- Hyogo Medical University Hospital
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Kagoshima, Giappone, 890-8520
- Kagoshima University Hospital
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Kagoshima, Giappone, 892-0843
- Kagoshima IBD Gastroenterology Clinic
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Kamakura, Giappone, 247-0056
- Ofuna Chuo Hospital
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Kanazawa, Giappone, 9208641
- Kanazawa University Hospital
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Kashiwa, Giappone, 277-0871
- Tsujinaka Hospital Kashiwanoha
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Kawagoe, Giappone, 350-8550
- Saitama Medical University Saitama Medical Center
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Kitakyushu, Giappone, 800-0296
- Kyushu Rosai Hospital
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Kobe, Giappone, 650-0017
- Kobe University Hospital
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Kumamoto, Giappone, 861-8520
- Japanese Red Cross Kumamoto Hospital
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Kurume, Giappone, 830-0011
- Kurume University Hospital
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Kyoto, Giappone, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Mitaka, Giappone, 181-8611
- Kyorin University Hospital
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Morioka, Giappone, 020-8505
- Iwate Medical University Hospital
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Nagaoka, Giappone, 940-2085
- Nagaoka Red Cross Hospital
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Nagasaki, Giappone, 852-8501
- Nagasaki University Hospital
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Nagoya, Giappone, 466 8560
- Nagoya University Hospital
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Niigata, Giappone, 951-8520
- Niigata University Medical And Dental Hospital
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Okayama, Giappone, 700-8558
- Okayama University Hospital
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Osaka, Giappone, 545-8586
- Osaka City University Hospital
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Osaka, Giappone, 530-0011
- Kinshukai Infusion Clinic
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Osaka, Giappone, 553-0003
- Japan Community Health Care Organization Osaka Hospital
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Saga, Giappone, 849-0937
- Saga University Hospital
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Saitama, Giappone, 336-0963
- Tokitokai Tokito Clinic Coloproctology Center
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Sakura, Giappone, 285-8741
- Toho University Sakura Medical Center
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Sapporo, Giappone, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Sapporo, Giappone, 004-0041
- Sapporo Tokushukai Hospital
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Sapporo, Giappone, 060-0033
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
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Sapporo, Giappone, 060-8556
- Sapporo Medical University Hospital
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Sendai, Giappone, 980-8574
- Tohoku University Hospital
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Shimotsuga-gun, Giappone, 321-0293
- Dokkyo Medical University Hospital
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Shimotsuke, Giappone, 329-0498
- Jichi Medical University Hospital
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Shinjuku Ku, Giappone, 162 8655
- Center Hospital of the National Center for Global Health and Medicine
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Shinjuku-Ku, Giappone, 162-8666
- Tokyo Women's Medical University Hospital
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Sumida Ku, Giappone, 130 8575
- Tokyo Metropolitan Bokutoh Hospital
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Takamatsu, Giappone, 760-0017
- Takamatsu Red Cross Hospital
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Tokyo, Giappone, 108-8642
- Kitasato University Kitasato Institute Hospital
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Tokyo, Giappone, 105 8471
- The Jikei University Hospital
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Toyama, Giappone, 9308550
- Toyama Prefectural Central Hospital
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Toyota, Giappone, 470-1219
- Ieda Hospital
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Tsu, Giappone, 514-8507
- Mie University Hospital
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Yokohama, Giappone, 232 0024
- Yokohama City University Medical Center
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Ōtsu, Giappone, 520-2192
- Shiga University of Medical Science Hospital
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Amman, Giordania, 11942
- Jordan University Hospital
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Amman, Giordania
- Abdali Hospital
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Irbid, Giordania, 22110
- King Abdullah University Hospital
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Irbid, Giordania, 21110
- Irbid Specialty Hospital
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Athens, Grecia, 115 27
- Sotiria General State Hospital of Chest Diseases
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Athens, Grecia, 115 27
- General Hospital of Athens 'Ippokrateion'
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Thessaloniki, Grecia, 54642
- Hippokration Hospital
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Ahmedabad, India, 380009
- ICON Hospital Orchid Medi services and Research Private Limited
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Bengaluru, India, 560054
- M S Ramaiah Medical College and Hospital
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Bhubaneswar, India, 751030
- Siksha O Anusandhan University - Institute of Medical Scienc
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Chennai, India, 600026
- Srm Institutes For Medical Science (Sims)
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Gūrgaon, India, 122002
- Fortis Memorial Research Institute
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Hyderabad, India, 500082
- Yashoda Super Speciality Hospitals 1
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Hyderabad, India, 500082
- Asian Institute Of Gastroenterology
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Mumbai, India, 400016
- P D Hinduja National Hospital and Medical Research Center
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New Delhi, India, 110029
- All India Institute of Medical Sciences
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Secunderabad, India, 500003
- Yashoda Super Speciality Hospitals
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Surat, India, 395002
- Surat Institute of Digestive Sciences Hospitals
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Surat, India, 395009
- Gujarat Gastro and Vascular Hospital
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Afula, Israele, 1834111
- Haemek Medical Center - Afula
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Haifa, Israele, 31096
- Rambam Medical Center
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Haifa, Israele, 31048
- Bnai Zion Medical Center
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Jerusalem, Israele, 9103102
- Shaare Zedek Medical Center
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Jerusalem, Israele, 91120
- Hadassah Hebrew University Medical Center
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Petah Tikva, Israele, 4941492
- Rabin Med Ctr Beilinson Hosp
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Rehovot, Israele, 76100
- Kaplan Medical Center
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Tel Aviv, Israele, 6423906
- Tel Aviv Sourasky Medical Center
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Tel HaShomer, Israele, 52621
- The Chaim Sheba Medical Center
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Tzrifin, Israele, 70300
- Assaf Harofeh Medical Center
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Bari, Italia, 70124
- Università degli Studi di Bari
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Catania, Italia, 95126
- A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale
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Messina, Italia, 98125
- AOU Policlinico G.Martino
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Milan, Italia, 20132
- Ospedale San Raffaele
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Monopoli, Italia, 70043
- Ospedale Specializzato in Gastroenterologia Saverio de Bellis
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Monserrato, Italia, 09042
- Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
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Monza, Italia, 20090
- Azienda Ospedaliera San Gerardo
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Negrar ( Ve), Italia, 37024
- Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
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Palermo, Italia, 90146
- Ospedale Villa Sofia-Cervello
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Roma, Italia, 00168
- Catholic University of Sacred Hearth
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Rozzano, Italia, 20089
- IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
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Torino, Italia, 10126
- Ospedale Molinette, AO Città della Salute e della Scienza di
-
-
-
-
-
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
-
-
-
-
-
Gjettum, Norvegia, 1346
- Vestre Viken HF Baerum Sykehus
-
Lørenskog, Norvegia, 1478
- Akershus Universitetssykehus
-
Oslo, Norvegia, 0450
- Oslo University Hospital HF Ulleval sykehus
-
Tromsø, Norvegia, N-9038
- Universitetssykehuset Nord-Norge HF
-
Ålesund, Norvegia, 6010
- Alesund sjukehus
-
-
-
-
-
Dunedin, Nuova Zelanda, 9016
- Dunedin Hospital
-
Lower Hutt, Nuova Zelanda, 5010
- Hutt Hospital
-
Wellington, Nuova Zelanda, 6021
- Wellington Hospital
-
-
-
-
-
Amsterdam, Olanda, 1105 AZ
- Academisch Medisch Centrum Universiteit van Amsterdam
-
Dordrecht, Olanda, 3318 AT
- Albert Schweitzer Ziekenhuis
-
Leiden, Olanda, 2333 ZA
- Leiden University Medical Center
-
Maastricht, Olanda, 6229 HX
- Maastricht Universitair Medisch Centrum
-
Rotterdam, Olanda, 3015 GD
- Erasmus MC
-
Utrecht, Olanda, 3508 GA
- UMC Utrecht
-
-
-
-
-
Bydgoszcz, Polonia, 85-168
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
-
Krakow, Polonia, 30 363
- Centrum Medyczne Plejady
-
Krakow, Polonia, 31-513
- Centrum Medyczne Promed
-
Lodz, Polonia, 90-644
- AmiCare Centrum Medyczne
-
Lublin, Polonia, 20-583
- Gastromed ZOZ
-
Olsztyn, Polonia, 10 561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
-
Poznan, Polonia, 61-293
- Twoja Przychodnia
-
Poznan, Polonia, 61 441
- Synexus Polska Sp z o o
-
Rzeszów, Polonia, 35-326
- Centrum Medyczne Medyk
-
Sopot, Polonia, 81-756
- Endoskopia Sp z o.o.
-
Szczecin, Polonia, 71-685
- Sonomed Sp. z o.o.
-
Torun, Polonia, 87 100
- GASTROMED Sp. z o.o.
-
Warsaw, Polonia, 00 632
- Centrum Zdrowia Matki Dziecka i Mlodziezy
-
Warsaw, Polonia, 03 580
- NZOZ Vivamed
-
Warsaw, Polonia, 03 712
- Bodyclinic Sp. z o.o. sp. k
-
Warsaw, Polonia, 02-655
- Reumatika-Centrum Reumatologii, NZOZ
-
Warsaw, Polonia, 02 507
- Centralny Szpital Kliniczny Mswia
-
Wroclaw, Polonia, 52-416
- Centrum Medyczne Oporow
-
Wroclaw, Polonia, 50 449
- Melita Medical Sp. z o.o.
-
Włocławek, Polonia, 87-800
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
-
Zamość, Polonia, 22-400
- ETG Zamosc
-
-
-
-
-
Lisbon, Portogallo, 1649-035
- Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria
-
Portimão, Portogallo, 8500-338
- Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
-
Porto, Portogallo, 4434-502
- Centro Hospitalar Vila Nova de Gaia
-
Santa Maria da Feira, Portogallo, 4520-211
- Centro Hospitalar de Entre o Douro e Vouga, E.P.E
-
-
-
-
-
Belfast, Regno Unito, BT12 6BA
- Royal Victoria Hospital
-
Birmingham, Regno Unito, B15 2TH
- University Hospitals Birmingham NHS Foundation Trust
-
Cambridge, Regno Unito, CB2 0QQ
- Addenbrooke's Hospital
-
Glasgow, Regno Unito, G4 0SF
- Glasgow Royal Infirmary
-
Glasgow, Regno Unito, G51 4TF
- Queen Elizabeth University Hospital
-
High Wycombe, Regno Unito, HP112QW
- Velocity Clinical Research
-
London, Regno Unito, E111NR
- Whipps Cross University Hospital
-
London, Regno Unito, SW19 0QT
- St Georges Healthcare NHS Trust
-
Oxford, Regno Unito, OX3 9DU
- John Radcliffe Hospital
-
Wolverhampton, Regno Unito, WV10 0QP
- New Cross Hospital
-
-
-
-
-
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, Slovenia, 3000
- Splosna bolnisnica Celje
-
Ljubljana, Slovenia, 1000
- Univerzitetni klinicni center Ljubljana
-
-
-
-
-
Madrid, Spagna, 28046
- Hosp. Univ. La Paz
-
Pamplona, Spagna, 31008
- Hosp. de Navarra
-
Pontevedra, Spagna, 36071
- Hosp. Montecelo
-
Sabadell, Spagna, 8208
- Corporacio Sanitari Parc Tauli
-
Santander, Spagna, 39008
- Hosp. Univ. Marques de Valdecilla
-
Torrejón de Ardoz, Spagna, 28850
- Hosp. Univ. de Torrejon
-
-
-
-
Alabama
-
Birmingham, Alabama, Stati Uniti, 35233
- University of Alabama Liver Center
-
-
Arizona
-
Tucson, Arizona, Stati Uniti, 85715
- Del Sol Research Management, LLC
-
-
Arkansas
-
Little Rock, Arkansas, Stati Uniti, 72205
- Moore Clinical Trials, LLC
-
-
California
-
Apple Valley, California, Stati Uniti, 92307
- Om Research LLC
-
Arcadia, California, Stati Uniti, 91006
- Valley Gastroenterology Medical Group
-
Coronado, California, Stati Uniti, 92118
- Southern California Research Center
-
Lancaster, California, Stati Uniti, 93534
- Desert Gastroenterology Associates
-
Los Angeles, California, Stati Uniti, 90095
- UCLA
-
Los Angeles, California, Stati Uniti, 90048
- Cedars Sinai Medical Center
-
Newport Beach, California, Stati Uniti, 92658
- Hoag Memorial Hospital
-
Orange, California, Stati Uniti, 92868
- UCI Irvine Medical Center
-
San Diego, California, Stati Uniti, 92123
- Medical Associates Research Group, Inc.
-
San Francisco, California, Stati Uniti, 94115
- University of California San Francisco
-
-
Colorado
-
Aurora, Colorado, Stati Uniti, 80045
- University of Colorado
-
-
Connecticut
-
Hamden, Connecticut, Stati Uniti, 06518
- Medical Research Center of Connecticut
-
New Haven, Connecticut, Stati Uniti, 06510
- Yale University School Of Medicine
-
-
District of Columbia
-
Washington D.C., District of Columbia, Stati Uniti, 20007
- MedStar Georgetown University Hospital
-
-
Florida
-
Coconut Creek, Florida, Stati Uniti, 33066
- Pioneer Research Solutions Inc.
-
Homestead, Florida, Stati Uniti, 33032
- Homestead Associates in Research Inc
-
Kissimmee, Florida, Stati Uniti, 34741
- Osceola Mental Health D/B/A Park Place Behavioral Health Care
-
Lakewood Rch, Florida, Stati Uniti, 34211
- Florida Research Center Inc.
-
Miami, Florida, Stati Uniti, 33136
- University of Miami Hospital
-
Naples, Florida, Stati Uniti, 34102
- Gastroenterology Group Of Naples
-
Orlando, Florida, Stati Uniti, 32808
- Omega Research Consultants
-
St. Petersburg, Florida, Stati Uniti, 33705
- Synergy Clinical Research
-
Tampa, Florida, Stati Uniti, 33609
- GCP Clinical Research
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30342
- Atlanta Gastroenterology Associates
-
Atlanta, Georgia, Stati Uniti, 30342
- University of Mississippi Medical Center
-
Macon, Georgia, Stati Uniti, 31201
- Gastroenterolgy Associates of Central GA
-
Marietta, Georgia, Stati Uniti, 30060
- Gastrointestinal Specialists of Georgia
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60611
- Northwestern University
-
-
Indiana
-
Indianapolis, Indiana, Stati Uniti, 46202
- IU Health University Hospital
-
New Albany, Indiana, Stati Uniti, 47150
- Gastroenterology of Southern Indiana
-
-
Kansas
-
Topeka, Kansas, Stati Uniti, 66606
- Cotton O'Neil Digestive Health Center
-
Wichita, Kansas, Stati Uniti, 67208
- Ascension via Christi Research
-
Wichita, Kansas, Stati Uniti, 67214-3124
- Univ. of KS School of Med
-
-
Kentucky
-
Crestview Hills, Kentucky, Stati Uniti, 41017
- Tri-State Gastroenterology Assoc
-
Lexington, Kentucky, Stati Uniti, 40536
- University of Kentucky
-
Louisville, Kentucky, Stati Uniti, 40202
- Jewish Hospital
-
-
Louisiana
-
Lafayette, Louisiana, Stati Uniti, 70503
- Gastroenterology Clinic of Acadiana
-
Marrero, Louisiana, Stati Uniti, 70072
- Tandem Clinical Research
-
New Orleans, Louisiana, Stati Uniti, 70121
- Ochsner Medical Center
-
-
Maryland
-
Chevy Chase, Maryland, Stati Uniti, 20815
- Chevy Chase Clinical Research
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02215-5400
- Lahey Hospital & Medical Center
-
Chestnut Hill, Massachusetts, Stati Uniti, 02467
- Brigham And Women's Hospital
-
South Dartmouth, Massachusetts, Stati Uniti, 02747
- FC Research, LLC
-
-
Michigan
-
Livonia, Michigan, Stati Uniti, 48152
- Detroit Clinical Research Center
-
Ypsilanti, Michigan, Stati Uniti, 48197
- Huron Gastroenterology Associates Center for Digestive Care
-
-
Mississippi
-
Flowood, Mississippi, Stati Uniti, 39232
- Gastrointestinal Associates LLP
-
-
Missouri
-
St Louis, Missouri, Stati Uniti, 63110
- Washington University
-
-
Nevada
-
Las Vegas, Nevada, Stati Uniti, 89113
- Las Vegas Medical Research
-
Las Vegas, Nevada, Stati Uniti, 89148
- Care Access Las Vegas
-
-
New Hampshire
-
Lebanon, New Hampshire, Stati Uniti, 03756
- Dartmouth Hitchcock
-
-
New York
-
Great Neck, New York, Stati Uniti, 11021
- Northwell Health
-
Jackson Heights, New York, Stati Uniti, 11372
- A1 Clinical Research
-
New York, New York, Stati Uniti, 10021
- Weill Cornell Medical College
-
New York, New York, Stati Uniti, 10075
- Lenox Hill Hospital
-
Utica, New York, Stati Uniti, 13502-6313
- Mohawk Valley Endoscopy Center
-
-
North Carolina
-
Chapel Hill, North Carolina, Stati Uniti, 27599-7080
- University of North Carolina
-
Charlotte, North Carolina, Stati Uniti, 28210
- Tryon Medical Group
-
Winston-Salem, North Carolina, Stati Uniti, 27103
- PMG Research of Winston-Salem
-
-
Ohio
-
Cleveland, Ohio, Stati Uniti, 44106
- University Hospitals Case Medical Center
-
Cleveland, Ohio, Stati Uniti, 44195-6501
- Cleveland Clinic
-
Westlake, Ohio, Stati Uniti, 44145
- Northshore Gastroenterology Research, LLC
-
-
Oregon
-
Portland, Oregon, Stati Uniti, 97220-9428
- The Oregon Clinic
-
-
Pennsylvania
-
Harrisburg, Pennsylvania, Stati Uniti, 17110-3673
- Susquehanna Gastroenterology Associates
-
Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania - Perelman School of Medicine
-
Smithfield, Pennsylvania, Stati Uniti, 15478
- Frontier Clinical Research
-
-
South Carolina
-
Charleston, South Carolina, Stati Uniti, 29425
- Medical University of South Carolina
-
Rock Hill, South Carolina, Stati Uniti, 29732
- Digestive Disease Associates
-
-
Tennessee
-
Germantown, Tennessee, Stati Uniti, 38138
- Saint Francis Hospital
-
Hixson, Tennessee, Stati Uniti, 37343
- Galen Medical Group
-
Johnson City, Tennessee, Stati Uniti, 37604
- Etsu Quillen College Of Medicine
-
Nashville, Tennessee, Stati Uniti, 37067
- Vanderbilt University Medical Center
-
-
Texas
-
Austin, Texas, Stati Uniti, 78750
- Amel Med LLC Research
-
Dallas, Texas, Stati Uniti, 75390-9063
- UT Southwestern Medical Center
-
Dallas, Texas, Stati Uniti, 75242
- Baylor University Medical Center
-
Houston, Texas, Stati Uniti, 77034
- Accurate Clinical Research
-
San Antonio, Texas, Stati Uniti, 78229
- Gastroenterology Clinic Of San Antonio P A
-
Southlake, Texas, Stati Uniti, 76092
- Texas Digestive Disease Consultants
-
Tyler, Texas, Stati Uniti, 75701
- Digestive Health Specialists
-
-
Utah
-
Ogden, Utah, Stati Uniti, 84403
- Care Access Research, Ogden
-
Salt Lake City, Utah, Stati Uniti, 84124
- Care Access Research- Salt Lake City
-
-
Virginia
-
Charlottesville, Virginia, Stati Uniti, 22908
- University of Virginia
-
Richmond, Virginia, Stati Uniti, 23249
- Hunter Holmes McGuire Veterans Affairs Medical Center
-
-
Washington
-
Bellevue, Washington, Stati Uniti, 98004
- Washington Gastroenterology, PLLC
-
Seattle, Washington, Stati Uniti, 98104
- Swedish Medical Center
-
Seattle, Washington, Stati Uniti, 98195
- University of Washington Digestive Disease Center
-
Tacoma, Washington, Stati Uniti, 98405
- Digestive Health Specialists 1
-
-
West Virginia
-
Huntington, West Virginia, Stati Uniti, 25701
- Marshall Health Clinical Research Center
-
-
-
-
-
Benoni, Sud Africa, 1501
- Worthwhile Clinical Trials Lakeview Hospital
-
Cape Town, Sud Africa, 7925
- Clinical Research Centre University of Cape Town
-
Cape Town, Sud Africa, 7925
- Groote Schur Hospital
-
Cape Town, Sud Africa, 7500
- Mediclinic Panorama
-
Cape Town, Sud Africa, 7800
- Inspired GI Care
-
Durban, Sud Africa, 3610
- Hillcrest private
-
-
-
-
-
Solna, Svezia, 17176
- Karolinska University Hospital
-
Stockholm, Svezia, 116 91
- Ersta sjukhus
-
Örebro, Svezia, 70185
- Universitetssjukhuset Orebro
-
-
-
-
-
Basel, Svizzera, 4056
- Universitatsspital Basel
-
Bern, Svizzera, 3010
- Inselspital Universitatsspital Bern
-
Bern, Svizzera, 3012
- Gastroenterologische Praxis Balsiger und Seibold
-
Sankt Gallen, Svizzera, 9007
- Kantonsspital St Gallen
-
Zurich, Svizzera, 8091
- UniversitaetsSpital Zuerich
-
-
-
-
-
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
-
-
-
-
-
Budapest, Ungheria, 1036
- Obudai Egeszsegugyi Centrum Kft
-
Budapest, Ungheria, 1082
- Semmelweis Egyetem
-
Budapest, Ungheria, 1088
- Semmelweis Egyetem I.Belgyogyaszati Klinika
-
Gyöngyös, Ungheria, 3200
- Bugat Pal Korhaz
-
Szeged, Ungheria, H-6720
- Szegedi Tudomanyegyetem
-
Szombathely, Ungheria, H-9700
- Markusovszky Egyetemi Oktatokorhaz
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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'
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
6
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Comparatore placebo: 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. |
|
Sperimentale: 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. |
|
Sperimentale: 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. |
|
Sperimentale: 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. |
|
Sperimentale: 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. |
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants with Clinical Remission at Week 48
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Up to Week 48
|
Clinical laboratory parameters over time will be reported. |
Up to Week 48
|
|
Vital Sign Parameters Over Time
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to Week 48
|
Percentage of participants with antibodies to guselkumab will be reported. |
Up to Week 48
|
|
Titers of Antibodies to Guselkumab
Lasso di tempo: Up to Week 48
|
Titers of antibodies to guselkumab will be reported. |
Up to Week 48
|
|
Percentage of Participants with Antibodies to Golimumab
Lasso di tempo: Up to Week 48
|
Percentage of participants with antibodies to golimumab will be reported. |
Up to Week 48
|
|
Titers of Antibodies to Golimumab
Lasso di tempo: Up to Week 48
|
Titers of antibodies to golimumab will be reported. |
Up to Week 48
|
|
Percentage of Participants with Neutralizing Antibodies to Guselkumab.
Lasso di tempo: 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
Lasso di tempo: Up to Week 48
|
Percentage of participants with neutralizing antibodies to golimumab will be reported. |
Up to Week 48
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
22 luglio 2022
Completamento primario (Effettivo)
Completamento primario
23 maggio 2025
Completamento dello studio (Stimato)
Completamento dello studio
5 novembre 2029
Date di iscrizione allo studio
Primo inviato
Primo inviato
15 febbraio 2022
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
15 febbraio 2022
Primo Inserito (Effettivo)
Primo Inserito
16 febbraio 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
4 novembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 novembre 2026
Ultimo verificato
Ultimo verificato
1 novembre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- CR109178
- 2021-003314-39 (Numero EudraCT)
- 78934804CRD2001 (Altro identificatore: Janssen Research & Development, LLC)
- 2023-504741-32-00 (Identificatore di registro: EUCT number)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .