Uno studio sulla terapia sottocutanea con Guselkumab nei partecipanti con malattia di Crohn da moderatamente a gravemente attiva (GRAVITI)
24 settembre 2026 aggiornato da: Janssen Research & Development, LLC
Uno studio multicentrico randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare l'efficacia e la sicurezza della terapia di induzione sottocutanea con Guselkumab nei partecipanti con malattia di Crohn da moderatamente a gravemente attiva
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
350
Fase
- Fase 3
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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Clayton, Australia, 3168
- Monash Health, Monash Medical Centre
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North Mackay, Australia, 4740
- Coral Sea Clinical Research Institute
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Aalst, Belgio, 9300
- OLV Ziekenhuis Aalst
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Brussels, Belgio, 1070
- Hopital Erasme
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Brussels, Belgio, 1000
- CHU Saint-Pierre
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Ghent, Belgio, 9000
- Universitair Ziekenhuis Gent
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Roeselare, Belgio, 8800
- Algemeen Ziekenhuis Delta
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Banja Luka, Bosnia Erzegovina, 78000
- University hospital Clinical centre Banja Luka
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Sarajevo, Bosnia Erzegovina, 71000
- Clinical Center University of Sarajevo
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Sarajevo, Bosnia Erzegovina, 71000
- Polyclinic Dr. Al-Tawil
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Tešanj, Bosnia Erzegovina, 74260
- General Hospital Tesanj
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Tuzla, Bosnia Erzegovina, 75000
- Plava poliklinika Tuzla
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Zenica, Bosnia Erzegovina, 72000
- Cantonal Hospital Zenica
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Botucatu, Brasile, 18608-025
- Universidade Estadual Paulista 'Julio De Mesquita Filho'
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Brasília, Brasile, 70200-730
- CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
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Brasília, Brasile, 72145 450
- Chronos Clinica Medica Ltda
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Campinas, Brasile, 13060-904
- Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
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Curitiba, Brasile, 80430-180
- CDC - Centro Digestivo de Curitiba
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Fortaleza, Brasile, 60430-370
- Universidade Federal Do Ceara
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Jaú, Brasile, 17201-130
- Centro de Estudos Clínicos do Interior Paulista - CECIP
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Macaé, Brasile, 27910-020
- Cliged
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Natal, Brasile, 59062 000
- Liga Norte Riograndense Contra O Cancer
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Passo Fundo, Brasile, 99010-120
- Instituto Mederi de Pesquisa e Saude
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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, 90160-092
- Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
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Porto Alegre, Brasile, 90430-001
- NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Recife, Brasile, 51011040
- Hospital das Clinicas - Universidade Federal de Pernambuco
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Salvador, Brasile, 40110-060
- Universidade Federal da Bahia - Hospital Professor Edgard Santos
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Salvador, Brasile, 40150150
- SER - Servicos Especializados em Reumatologia da Bahia
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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 Bernardo do Campo, Brasile, 09715-090
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
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São José do Rio Preto, Brasile, 15015-110
- Kaiser Hospta
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São José do Rio Preto, Brasile, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
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São Paulo, Brasile, 04543-000
- Instituto D Or de Pesquisa e Ensino IDOR
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São Paulo, Brasile, 03325-050
- BR TRIALS Ensaios Clinicos e Consultoria Ltda
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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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Teresina, Brasile, 64049-550
- Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
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Votuporanga, Brasile, 15501 405
- Integral Centro de Pesquisas Clinicas
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Ontario
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre
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North Bay, Ontario, Canada, P1B 2H3
- North Bay Dermatology Centre
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Brno, Cechia, 636 00
- Fakultni nemocnice Brno
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Hradec Králové, Cechia, 500 05
- Fakultni nemocnice Hradec Kralove
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Kladno, Cechia, 27259
- Oblastni nemocnice Kladno a.s.
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Prague, Cechia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Slaný, Cechia, 274 01
- Nemocnice Slany
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Bengbu, Cina, 233004
- The Affiliated Hospital of Bengbu Medical College
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Changsha, Cina, 410008
- Xiangya Hospital Central South University
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Changsha, Cina, 410011
- 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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Fuzhou, Cina, 350005
- The First Affiliated Hospital of Fujian Medical University
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Ganzhou, Cina, 341000
- First Affiliated Hospital of Gannan Medical University
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Guangzhou, Cina, 510180
- Guangzhou First Municipal People's Hospital
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Guangzhou, Cina, 510080
- Guangdong Provincial People's Hospital
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Guangzhou, Cina, 510260
- Guangzhou Medical University
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Hangzhou, Cina, 310006
- Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
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Hangzhou, Cina, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Hefei, Cina, 230022
- The First Affiliated Hospital of Anhui Medical University
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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, 210006
- Nanjing 1st Hospital
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Quanzhou, Cina, 362002
- The First Hospital of Quanzhou
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Shanghai, Cina, 200040
- Huashan Hospital Fudan University
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Shanghai, Cina, 200120
- Shanghai East Hospital
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Shenyang, Cina, 110022
- Shengjing Hospital Of China Medical University
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Suzhou, Cina
- The first affiliated hospital of suzhou University
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Wuxi, Cina, 214023
- Wuxi People s Hospital
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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, 41404
- Kyungpook National University Chilgok Hospital
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Busan, Corea del Sud, 48108
- Inje University Haeundae Paik Hospital
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Busan, Corea del Sud, 49267
- Kosin University Gospel Hospital
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Busan, Corea del Sud, 602739
- DongA Medical Center
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Daegu, Corea del Sud, 42415
- Yeungnam University Medical Center
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Daejeon, Corea del Sud, 34943
- The Catholic University of Korea Seoul St.Mary's Hospital
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Dongdaemun-gu, Corea del Sud, 02447
- Kyung Hee University Hospital
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Goyang-si, Corea del Sud, 10326
- Dongguk University Ilsan Hospital
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Gwangju, Corea del Sud, 61469
- Chonnam National University Hospital
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Gyeonggi-do, Corea del Sud, 13496
- CHA Bundang Medical Center, CHA University
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Gyeonggi-do, Corea del Sud, 16247
- The Catholic university of Korea, St. Vincent's Hospital
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Seoul, Corea del Sud, 06351
- Samsung Medical Center
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Seoul, Corea del Sud, 03181
- Kangbuk Samsung Hospital
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Seoul, Corea del Sud, 03722
- Yonsei University College of Medicine
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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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Wŏnju, Corea del Sud, 26426
- Wonju Christian Hospital
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Yangch’ŏn-gu, Corea del Sud, 07985
- Ewha Womans University Mokdong Hospital
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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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Zadar, Croazia, 23000
- Opca bolnica Zadar
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Zagreb, Croazia, 10000
- Poliklinika Solmed
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Esbjerg, Danimarca, 6700
- Sydvestjysk Sygehus
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Hilleroed, Danimarca, 3400
- Nordsjaellands Hospital - Hillerod
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Bayonne, Francia, 64100
- Centre Hospitalier de la Cote Basque
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Besançon, Francia, 25000
- CHRU Besancon Hopital Jean Minjoz
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Colombes, Francia, 92701
- Hopital Louis Mourier
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Nantes, Francia, 44093
- CHU de Nantes hotel Dieu
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Nice, Francia, 06202
- CHU de Nice Hopital de l Archet
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Paris, Francia, 75877
- Hôpital Bichat
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Pierre-Bénite, Francia, 69495
- Hospices Civils de Lyon HCL
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Reims, Francia, 51092
- Hôpital Robert Debré
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Saint-Priest-en-Jarez, Francia, 42270
- CHU Saint Etienne Hopital Nord
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Strasbourg, Francia, 67098
- CHRU Strasbourg
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Toulouse, Francia, 31059
- CHU Rangueil
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Berlin, Germania, 14050
- DRK Kliniken Westend
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Berlin, Germania, 14163
- Krankenhaus Waldfriede Mitte
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Berlin, Germania, 10117
- Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
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Berlin, Germania, 10318
- CED Studienzentrum Karlshorst
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Braunschweig, Germania, 38126
- Staedtisches Klinikum Braunschweig
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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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Duisburg, Germania, 47055
- MVZ Sanaklinikum Duisburg
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Halle, Germania, 6108
- Studiengesellschaft Mitteldeutschland GmbH
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Hanover, Germania, 30625
- Medizinische Hochschule Hannover
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Jerichow, Germania, 39319
- Praxisgemeinschaft Jerichow
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Mannheim, Germania, 68167
- Universitaetsklinikum Mannheim
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Nordhausen, Germania, 99734
- Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
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Bunkyō City, Giappone, 113-8431
- Juntendo University Hospital
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Chūōku, Giappone, 1040061
- Ginza central clinic
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Fukui-ken, Giappone, 910-8526
- Fukui Prefectural Hospital
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Fukuoka, Giappone, 814-0180
- Fukuoka University Hospital
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Fukuoka, Giappone, 815-8555
- Japanese Red Cross Fukuoka Hospital
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Fukuyama, Giappone, 720-8520
- National Hospital Organization Fukuyama Medical Center
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Gamagōri, Giappone, 443-8501
- Gamagori City Hospital
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Gunma, Giappone, 371-0034
- Gunma University Hospital
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Hachinohe, Giappone, 031-8555
- Hachinohe City Hospital
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Hamamatsu, Giappone, 431 3192
- Hamamatsu University Hospital
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Hamamatsu, Giappone, 432-8061
- Matsuda Hospital
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Higashi-Ibaraki, Giappone, 311-3193
- National Hospital Organization Mito Medical Center
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Hiroshima, Giappone, 737-8505
- Kure Kyosai Hospital
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Iizuka-shi, Giappone, 820-8505
- National Hospital Organization Shikoku Cancer Center
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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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Kashiwa, Giappone, 277-0871
- Tsujinaka Hospital Kashiwanoha
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Kitakyushu, Giappone, 800-0229
- Kyushu Rosai Hospital
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Kobe, Giappone, 650 0017
- Kobe University Hospital
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Kofu, Giappone, 400-8506
- Yamanashi Prefectural Central Hospital
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Koshigaya, Giappone, 343-8555
- Dokkyo Medical University Saitama Medical Center
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Kurume, Giappone, 839-0809
- Hidaka Coloproctologic Clinic
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Kyoto, Giappone, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Kyoto, Giappone, 602-8026
- Japanese Red Cross Kyoto Daini Hospital
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Morioka, Giappone, 020-8505
- Iwate Medical University Hospital
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Nagasaki, Giappone, 852-8501
- Nagasaki University Hospital
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Nagoya, Giappone, 460-0022
- Yokoyama IBD Clinic
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Nakagami-gun, Giappone, 901-2132
- University of the Ryukyus Hospital
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Niigata, Giappone, 951 8520
- Niigata University Medical And Dental Hospital
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Nishinomiya, Giappone, 663-8014
- Nishinomiya Municipal Central Hospital
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Osaka, Giappone, 540-0006
- National Hospital Organization Osaka National Hospital
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Osaka, Giappone, 558-8558
- Osaka General Medical Center
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Osaka, Giappone, 543-8555
- Japanese Red Cross Osaka Hospital
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Osaka, Giappone, 530-0011
- Kinshukai Infusion Clinic
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Sapporo, Giappone, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Sendai, Giappone, 981-3213
- Takagi Clinic
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Sunto-gun, Giappone, 411-8611
- National Hospital Organization Shizuoka Medical Center
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Tokyo, Giappone, 160-0023
- Tokyo Medical University Hospital
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Toyota, Giappone, 470-0396
- Toyota Kosei Hospital
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Yokohama, Giappone, 232 0024
- Yokohama City University Medical Center
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Ōita, Giappone, 870-0033
- Oita Red Cross Hospital
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Ōtsu, Giappone, 520-2192
- Shiga University of Medical Science Hospital
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Amman, Giordania, 11183
- Khalidi Hospital and Medical Center
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Amman, Giordania, 11194
- The Speciality Hospital (TSH) / Advanced Clinical Center
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Amman, Giordania, 11196
- Istiklal Hospital
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Amman, Giordania, 1184
- Abdali Hospital
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Irbid, Giordania, 21110
- Irbid Specialty Hospital
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Irbid, Giordania, 22110
- Pharmaceutical Research Center Jordan University of Science and Technology Rheumatology
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Afula, Israele, 1834111
- Haemek Medical Center
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Beersheba, Israele, 84101
- Soroka University Medical Center
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Ramat Gan, Israele, 5265601
- The Chaim Sheba Medical Center
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Rehovot, Israele, 76100
- Kaplan Medical Center
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Tzrifin, Israele, 70300
- Assaf Harofeh Medical Center
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Bologna, Italia, 40138
- Policlinico Sant'Orsola Malpighi
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Milan, Italia, 20132
- Istituto Clinico Humanitas Rozzano, IRCCS
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Roma, Italia, 168
- Policlinico Universitario Agostino Gemelli
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Roma, Italia, 00128
- Università Campus Biomedico di Roma
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Kaunas, Lituania, 44307
- Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
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Vilnius, Lituania, LT-08661
- Vilnius University Hospital Santaros Klinikos, Public Institution
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Johor Bharu, Malaysia, 80100
- Hospital Sultanah Aminah
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Kota Bharu, Malaysia, 16150
- Hospital University Sains Malaysia
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Kota Kinabalu, Malaysia, 88586
- Hospital Raja Permaisuri Bainun
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Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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Kuantan, Malaysia, 25100
- Hospital Tengku Ampuan Afzan
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Christchurch, Nuova Zelanda, 8011
- Christchurch Hospital
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Dunedin, Nuova Zelanda, 9016
- Dunedin Hospital
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Amsterdam, Olanda, 1091 AC
- Onze Lieve Vrouwe Gasthuis
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Rotterdam, Olanda, 3045 PM
- Sint Franciscus Gasthuis
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Tilburg, Olanda, 5022 GC
- Elisabeth-TweeSteden Ziekenhuis
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Bialystok, Polonia, 15-322
- Gastromed Kralisz Romatowski Stachurska Sp. j.
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Bydgoszcz, Polonia, 85 231
- NZOZ Centrum Medyczne KERmed
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Chojnice, Polonia, 89-600
- Centrum Medyczne Lukamed
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Chojnice, Polonia, 89 600
- Centrum Medyczne Lukamed Sp z o o
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Chrzanów, Polonia, 32-500
- Sahlgrenska University Hospital
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Knurów, Polonia, 44 190
- MZ Badania Slowik Zymla Spolka jawna
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Krakow, Polonia, 30 149
- Malopolskie Centrum Kliniczne
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Krakow, Polonia, 30 363
- Centrum Medyczne Plejady
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Krakow, Polonia, 31 637
- Centrum Medyczne ProMiMed
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Lodz, Polonia, 90-752
- IP Clinic Sp. z o.o.
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Lodz, Polonia, 91 034
- Centrum Medyczne Med Gastr
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Lodz, Polonia, 90-644
- AmiCare Centrum Medyczne
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Lublin, Polonia, 20-412
- ETG Lublin
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Lublin, Polonia, 20 582
- REUMED Zespol Poradni Specjalistycznych Filia nr 2
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Nowy Targ, Polonia, 34 400
- Allmedica
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Olsztyn, Polonia, 10 561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
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Opole, Polonia, 45-819
- Twoja Przychodnia 1
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Piotrkow Trybunalski, Polonia, 97 300
- Centrum Medyczne
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Poznan, Polonia, 60 309
- EMC Instytut Medyczny SA PL CERTUS
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Poznan, Polonia, 61 441
- Synexus Polska Sp z o o
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Poznan, Polonia, 61 324
- Twoja Przychodnia
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Rzeszów, Polonia, 35-326
- Centrum Medyczne Medyk
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Skorzewo, Polonia, 60-185
- Centrum Medyczne Promed
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Sopot, Polonia, 81-756
- Endoskopia Sp z o.o.
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Sosnowiec, Polonia, 41-200
- Kiepury Clinic
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Straszów, Polonia, 28 200
- KO Med Centrum Medyczne
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Szczecin, Polonia, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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Szczecin, Polonia, 71-685
- Sonomed Sp. z o.o.
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Torun, Polonia, 87 100
- GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
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Tychy, Polonia, 43-100
- H-T Centrum Medyczne Endoterapia
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Warsaw, Polonia, 02-507
- Centralny Szpital Kliniczny MSWiA w Warszawie
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Warsaw, Polonia, 02 653
- Endoterapia
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Warsaw, Polonia, 00 632
- Centrum Zdrowia Matki Dziecka i Mlodziezy
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Warsaw, Polonia, 02 798
- Medical Concierge Centrum Medyczne
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Warsaw, Polonia, 03 580
- NZOZ Vivamed
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Warsaw, Polonia, 03-712
- Gabinety Lekarskie Bodyclinic
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Warsaw, Polonia, 04-501
- IBD Point Profesor Kierkus
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Wierzchosławice, Polonia, 33-122
- Centrum Zdrowia Tuchow
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Wroclaw, Polonia, 50-556
- Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
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Wroclaw, Polonia, 53 149
- Przychodnia Vistamed
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Wroclaw, Polonia, 53 611
- Centrum Medyczne Melita Medical
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Wroclaw, Polonia, 50-449
- Centrum Medyczne Melita Medical 2
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Włocławek, Polonia, 87-800
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
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Zamość, Polonia, 22-400
- Pro Life Medica Sp z o o ETG Zamosc
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Banská Bystrica, Slovacchia, 974 01
- FNsP F.D.R. Banska Bystrica
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Košice, Slovacchia, 040 13
- ENDOMED s.r.o
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Prešov, Slovacchia, 080 01
- GASTRO I. s.r.o.
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Gijón, Spagna, 33394
- Hosp. de Cabuenes
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Huelva, Spagna, 21005
- Hosp. Gral. Juan Ramon Jimenez
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Huelva, Spagna, 21002
- Hosp. Gral. Juan Ramon Jimenez 1
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Madrid, Spagna, 28031
- Hosp. Univ. Infanta Leonor
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Seville, Spagna, 41009
- Hosp. Virgen Macarena
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Vigo, Spagna, 36213
- Hosp. Alvaro Cunqueiro
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Villajoyosa, Spagna, 03570
- Hosp. de La Marina Baixa
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Alabama
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Dothan, Alabama, Stati Uniti, 36305
- Digestive Health Specialists of the Southeast
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Arizona
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Chandler, Arizona, Stati Uniti, 85224-1636
- Advanced Gastro P.C
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Scottsdale, Arizona, Stati Uniti, 85260
- Reliance Research
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205-6414
- Moore Clinical Trials, LLC
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Little Rock, Arkansas, Stati Uniti, 72223
- Central Arkansas Veterans Healthcare System
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California
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Anaheim, California, Stati Uniti, 92805
- Clinnova Research
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Lancaster, California, Stati Uniti, 93534
- Om Research LLC
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Lancaster, California, Stati Uniti, 93534
- Om Research LLC 1
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Los Alamitos, California, Stati Uniti, 90720
- United Gastroenterologists
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Los Angeles, California, Stati Uniti, 90048
- Paul Wallace MD
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Pasadena, California, Stati Uniti, 77505-3950
- Digestive System Healthcare
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San Diego, California, Stati Uniti, 92103
- Clinical Applications Laboratories, Inc
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San Diego, California, Stati Uniti, 92103-2120
- Northshore Gastroenterology Research, LLC
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Santa Maria, California, Stati Uniti, 93454
- Santa Maria Gastroenterology
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Walnut Creek, California, Stati Uniti, 94598
- Clinical Research of California
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Colorado
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Grand Junction, Colorado, Stati Uniti, 81505-1027
- Amel Med LLC Research
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Connecticut
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Danbury, Connecticut, Stati Uniti, 06810
- Western Connecticut Health Network/Danbury Hospital
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Florida
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Clearwater, Florida, Stati Uniti, 33762-5323
- Gastroenterology Associates of SW Florida
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Coconut Creek, Florida, Stati Uniti, 33066
- Pioneer Research Solutions Inc.
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DeBary, Florida, Stati Uniti, 32713
- Omega Research Consultants
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Hialeah, Florida, Stati Uniti, 33016
- Harmony Medical Research Institute, Inc.
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Kissimmee, Florida, Stati Uniti, 34741
- Central Florida Gastro Research
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Miami, Florida, Stati Uniti, 33155
- Community Research Foundation, Inc.
-
Naples, Florida, Stati Uniti, 34102
- Gastroenterology Group Of Naples
-
Orlando, Florida, Stati Uniti, 32803-1853
- Center for Digestive Health
-
Orlando, Florida, Stati Uniti, 32819
- Central Florida Internists
-
St. Petersburg, Florida, Stati Uniti, 33705
- Synergy Clinical Research
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30328
- Agile Clinical Research Trials, LLC
-
Atlanta, Georgia, Stati Uniti, 30224
- Atlanta Gastroenterology Specialists, PC
-
Decatur, Georgia, Stati Uniti, 30033
- Atlanta Center For Gastroenterology
-
Macon, Georgia, Stati Uniti, 31201
- Gastroenterolgy Associates of Central GA
-
Roswell, Georgia, Stati Uniti, 30076-4943
- Gastroenterology Consultants
-
-
Idaho
-
Boise, Idaho, Stati Uniti, 83706
- USF Asthma, Allergy, Immunology Clinical Research Unit
-
Idaho Falls, Idaho, Stati Uniti, 83404
- Grand Teton Research Group, PLLC
-
-
Illinois
-
Oakbrook Terrace, Illinois, Stati Uniti, 60618
- Lemah Creek Clinical Research
-
-
Kansas
-
Kansas City, Kansas, Stati Uniti, 66103-2937
- University of Kansas Medical Center
-
Leawood, Kansas, Stati Uniti, 66211
- BVL Clinical Research
-
Topeka, Kansas, Stati Uniti, 66606
- Cotton O'Neil Digestive Health Center
-
-
Kentucky
-
Crestview Hills, Kentucky, Stati Uniti, 41017
- Tri-State Gastroenterology Assoc
-
-
Louisiana
-
Marrero, Louisiana, Stati Uniti, 70072
- Tandem Clinical Research
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21202-2102
- Institute for Digestive Health and Liver Disease
-
Glen Burnie, Maryland, Stati Uniti, 21061
- Woodholme Gastroenterology Associates
-
-
Massachusetts
-
Chelmsford, Massachusetts, Stati Uniti, 01824
- Digestive Health Specialists PC
-
South Dartmouth, Massachusetts, Stati Uniti, 02747
- FC Research, LLC
-
-
Michigan
-
Chesterfield, Michigan, Stati Uniti, 48047
- Clinical Research Institute of Michigan, LLC
-
Livonia, Michigan, Stati Uniti, 48152
- Detroit Clinical Research Center
-
-
Mississippi
-
Jackson, Mississippi, Stati Uniti, 39216
- University of Mississippi Medical Center
-
-
New York
-
Brooklyn, New York, Stati Uniti, 11203
- SUNY Downstate Medical Center
-
Jackson Heights, New York, Stati Uniti, 11372
- Smart Medical Research
-
Middletown, New York, Stati Uniti, 10941
- Crystal Run Healthcare LLP
-
New York, New York, Stati Uniti, 10075
- New York Gastroenterology Associates
-
North Massapequa, New York, Stati Uniti, 11758
- DiGiovanna Institute for Medical Education & Research
-
Queens, New York, Stati Uniti, 11375
- A1 Clinical Network
-
-
North Carolina
-
Charlotte, North Carolina, Stati Uniti, 28207
- Carolinas Medical Center
-
Charlotte, North Carolina, Stati Uniti, 28277
- Onsite Clinical Solutions
-
Greenville, North Carolina, Stati Uniti, 27834
- Carolina Research
-
Winston-Salem, North Carolina, Stati Uniti, 27103
- Gastroenterology Associates of the Piedmont, P.A.
-
-
Ohio
-
Columbus, Ohio, Stati Uniti, 43214
- Central Ohio Endoscopy Center LLC
-
Dayton, Ohio, Stati Uniti, 45440
- Dayton Gastroenterology, Inc
-
Mentor, Ohio, Stati Uniti, 44060
- Great Lakes Gastroenterology
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Stati Uniti, 73104
- Oklahoma University Health Science Center
-
Oklahoma City, Oklahoma, Stati Uniti, 73112
- Integris Baptist Office
-
Oklahoma City, Oklahoma, Stati Uniti, 73120
- Central Sooner Research
-
Tulsa, Oklahoma, Stati Uniti, 74137-7061
- Essential Medical Research
-
-
Oregon
-
Portland, Oregon, Stati Uniti, 97220-9428
- The Oregon Clinic
-
-
Pennsylvania
-
Smithfield, Pennsylvania, Stati Uniti, 15478
- Frontier Clinical Research
-
-
South Carolina
-
Greenville, South Carolina, Stati Uniti, 29615
- Gastroenterology Associates P.A.
-
Myrtle Beach, South Carolina, Stati Uniti, 29572
- Carolina Health Specialists
-
-
Texas
-
Lubbock, Texas, Stati Uniti, 79424
- West Texas Clinical Research
-
Richmond, Texas, Stati Uniti, 77407
- Victoria Gastroenterology
-
San Antonio, Texas, Stati Uniti, 78229
- Gastroenterology Clinic Of San Antonio P A
-
San Antonio, Texas, Stati Uniti, 78232
- Wellness Clinical Research
-
Southlake, Texas, Stati Uniti, 76092
- Texas Digestive Disease Consultants
-
Tyler, Texas, Stati Uniti, 75701
- Digestive Health Specialists of Tyler
-
-
Utah
-
Salt Lake City, Utah, Stati Uniti, 84124
- Care Access Research- Salt Lake City
-
-
Virginia
-
Burke, Virginia, Stati Uniti, 22015
- Burke Internal Medicine and Research
-
Chesapeake, Virginia, Stati Uniti, 23320
- Gastroenterology Associates of Tidewater
-
-
-
-
-
Kaoshiung, Taiwan, 80756
- Kaohsiung Medical University Chung Ho Memorial Hospital
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
Taipei, Taiwan, 100
- National Taiwan University Hospital, Division of Infectious Diseases
-
Taipei, Taiwan, 110301
- Taipei Medical University
-
Taoyuan, Taiwan, 33305
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Ankara, Turchia (Türkiye), 06100
- Ankara Numune Egitim ve Arastirma Hastanesi
-
Ankara, Turchia (Türkiye), 06230
- Hacettepe University Hospital
-
Ankara, Turchia (Türkiye), 06560
- Gazi University Medical Faculty
-
Istanbul, Turchia (Türkiye), 34349
- Acibadem Fulya Hospital
-
Izmir, Turchia (Türkiye), 35040
- Ege Universitesi Tip Fakultesi
-
Mersin, Turchia (Türkiye), 33343
- Mersin University Medical Faculty
-
Samsun, Turchia (Türkiye), 55420
- Ondokuz Mayis University
-
Zonguldak, Turchia (Türkiye), 67000
- Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
-
-
-
-
-
Budapest, Ungheria, 1036
- Obudai Egeszsegugyi Centrum Kft
-
Budapest, Ungheria, H-1088
- Semmelweis Egyetem
-
Budapest, Ungheria, H-1136
- Pannónia Magánorvosi Centrum Kft
-
Budapest, Ungheria, 1097
- Egyesített Szent István és Szent László Kórház
-
Budapest, Ungheria, 1126
- Mh Egészségügyi Központ
-
Budapest, Ungheria, 1125
- Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
-
Kistarcsa, Ungheria, 2143
- Pest Megyei Flor Ferenc Korhaz
-
Mohács, Ungheria, 7700
- Mohacsi Korhaz
-
Pécs, Ungheria, 7624
- Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
-
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
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Diagnosis of Crohn's disease (CD) of at least 3 months in duration
- Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
- Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Exclusion Criteria:
- Current diagnosis of ulcerative colitis or indeterminate colitis
- Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
- Unstable doses of concomitant Crohn's disease therapy
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
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Group 1: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously. |
Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection. Guselkumab (Dose 2) will be administered by SC injection. |
|
Sperimentale: Group 2: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously. |
Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection. Guselkumab (Dose 3) will be administered by SC injection. |
|
Comparatore placebo: Group 3: Placebo
Participants will receive placebo injection subcutaneously. |
Placebo will be administered by SC injection. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission at Week 12
Lasso di tempo: At Week 12
|
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity. |
At Week 12
|
|
Percentage of Participants Who Achieved Endoscopic Response at Week 12
Lasso di tempo: At Week 12
|
Percentage of participants who achieved endoscopic response at Week 12 were reported. Endoscopic response was defined as greater than or equal to (>=) 50 percent (%) improvement from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, and presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, and rectum), each scored from 0 (best) to 3 (worst) for each segment except narrowing component for which the maximum total score (that is, stricturing) was 11 points. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease. |
At Week 12
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission at Week 24
Lasso di tempo: At Week 24
|
Percentage of participants who achieved clinical remission at Week 24 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity. |
At Week 24
|
|
Percentage of Participants Who Achieved Patient-reported Outcome (PRO)-2 Remission at Week 12
Lasso di tempo: At Week 12
|
Percentage of participants who achieved PRO-2 remission at Week 12 were reported. PRO-2 remission was defined as an abdominal pain (AP) mean daily score <=1, and stool frequency (SF) mean daily score <=3, and no worsening of AP or SF from baseline. Mean daily AP score based on the CDAI was defined as the sum of abdominal pain/cramps ratings in the previous 7 days in a diary card divided by the total number of days assessments were performed. Average daily SF score based on the CDAI was defined as the sum of number of liquid or very soft stools in the previous 7 days in a diary card divided by the total number of days assessments were performed. Mean daily SF and AP scores at a scheduled visit were not calculated if total number of days of assessment was less than 5. Higher PRO-2 scores indicated more severe disease. |
At Week 12
|
|
Percentage of Participants Who Achieved Clinical Response at Week 12
Lasso di tempo: At Week 12
|
Clinical response was defined as a decrease from baseline in CDAI score >= 100 points or CDAI score < 150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity. |
At Week 12
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 48
Lasso di tempo: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
Percentage of participants with TEAEs through Week 48 were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant participating in a clinical study and does not necessarily have a causal relationship with the study drug. An AE that occurred at or after the initial administration of study drug (Week 0) through data cutoff of Week 48 was considered treatment-emergent. |
Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
|
Percentage of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 48
Lasso di tempo: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
Percentage of participants with TESAEs through Week 48 were reported. An SAE was any untoward medical occurrence in a clinical study participant resulting in any of the following outcomes or was deemed significant for any other reason: death, life-threatening (immediate risk of dying), initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. An AE does not necessarily have a causal relationship with the study drug. Any SAE that occurred at or after the initial administration of study drug (Week 0) through the data cutoff of Week 48 was considered treatment-emergent. |
Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Discontinuation of Study Drug Through Week 48
Lasso di tempo: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
Percentage of participants with TEAEs leading to discontinuation of study drug through Week 48 were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant participating in a clinical study and does not necessarily have a causal relationship with the study drug. An AE that occurred at or after the initial administration of study drug (Week 0) through data cutoff of Week 48 was considered treatment-emergent. |
Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
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)
19 gennaio 2022
Completamento primario (Effettivo)
4 luglio 2023
Completamento dello studio (Stimato)
30 ottobre 2028
Date di iscrizione allo studio
Primo inviato
17 gennaio 2022
Primo inviato che soddisfa i criteri di controllo qualità
17 gennaio 2022
Primo Inserito (Effettivo)
19 gennaio 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CR109125
- 2020-006165-11 (Numero EudraCT)
- CNTO1959CRD3004 (Altro identificatore: Janssen Research & Development, LLC)
- 2023-504737-41-00 (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 .