Un estudio de la terapia subcutánea con guselkumab en participantes con enfermedad de Crohn activa de moderada a grave (GRAVITI)
24 de septiembre de 2026 actualizado por: Janssen Research & Development, LLC
Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y multicéntrico para evaluar la eficacia y la seguridad de la terapia de inducción subcutánea con guselkumab en participantes con enfermedad de Crohn activa de moderada a grave
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
350
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 14050
- DRK Kliniken Westend
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Berlin, Alemania, 14163
- Krankenhaus Waldfriede Mitte
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Berlin, Alemania, 10117
- Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
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Berlin, Alemania, 10318
- CED Studienzentrum Karlshorst
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Braunschweig, Alemania, 38126
- Staedtisches Klinikum Braunschweig
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Cologne, Alemania, 51103
- Evangelisches Krankenhaus Kalk
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Dachau, Alemania, 85221
- Medizinisches Versorgungszentrum (MVZ) Dachau
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Duisburg, Alemania, 47055
- MVZ Sanaklinikum Duisburg
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Halle, Alemania, 6108
- Studiengesellschaft Mitteldeutschland GmbH
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Hanover, Alemania, 30625
- Medizinische Hochschule Hannover
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Jerichow, Alemania, 39319
- Praxisgemeinschaft Jerichow
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Mannheim, Alemania, 68167
- Universitaetsklinikum Mannheim
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Nordhausen, Alemania, 99734
- Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
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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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Banja Luka, Bosnia y Herzegovina, 78000
- University hospital Clinical centre Banja Luka
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Sarajevo, Bosnia y Herzegovina, 71000
- Clinical Center University of Sarajevo
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Sarajevo, Bosnia y Herzegovina, 71000
- Polyclinic Dr. Al-Tawil
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Tešanj, Bosnia y Herzegovina, 74260
- General Hospital Tesanj
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Tuzla, Bosnia y Herzegovina, 75000
- Plava poliklinika Tuzla
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Zenica, Bosnia y Herzegovina, 72000
- Cantonal Hospital Zenica
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Botucatu, Brasil, 18608-025
- Universidade Estadual Paulista 'Julio De Mesquita Filho'
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Brasília, Brasil, 70200-730
- CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
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Brasília, Brasil, 72145 450
- Chronos Clinica Medica Ltda
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Campinas, Brasil, 13060-904
- Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
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Curitiba, Brasil, 80430-180
- CDC - Centro Digestivo de Curitiba
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Fortaleza, Brasil, 60430-370
- Universidade Federal Do Ceara
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Jaú, Brasil, 17201-130
- Centro de Estudos Clínicos do Interior Paulista - CECIP
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Macaé, Brasil, 27910-020
- Cliged
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Natal, Brasil, 59062 000
- Liga Norte Riograndense Contra O Cancer
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Passo Fundo, Brasil, 99010-120
- Instituto Mederi de Pesquisa e Saude
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Porto Alegre, Brasil, 90035-003
- Hospital das Clinicas de Porto Alegre
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Porto Alegre, Brasil, 90035-001
- Associacao Hospitalar Moinhos de Vento
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Porto Alegre, Brasil, 90160-092
- Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
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Porto Alegre, Brasil, 90430-001
- NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Recife, Brasil, 51011040
- Hospital das Clinicas - Universidade Federal de Pernambuco
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Salvador, Brasil, 40110-060
- Universidade Federal da Bahia - Hospital Professor Edgard Santos
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Salvador, Brasil, 40150150
- SER - Servicos Especializados em Reumatologia da Bahia
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Santo André, Brasil, 09080-110
- Pesquisare Saude
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Santos, Brasil, 11075-101
- Irmandade da Santa Casa da Misericórdia de Santos
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São Bernardo do Campo, Brasil, 09715-090
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
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São José do Rio Preto, Brasil, 15015-110
- Kaiser Hospta
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São José do Rio Preto, Brasil, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
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São Paulo, Brasil, 04543-000
- Instituto D Or de Pesquisa e Ensino IDOR
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São Paulo, Brasil, 03325-050
- BR TRIALS Ensaios Clinicos e Consultoria Ltda
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São Paulo, Brasil, 04039-004
- Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
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São Paulo, Brasil, 04543-011
- Hepatogastro
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Teresina, Brasil, 64049-550
- Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
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Votuporanga, Brasil, 15501 405
- Integral Centro de Pesquisas Clinicas
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Aalst, Bélgica, 9300
- OLV Ziekenhuis Aalst
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Brussels, Bélgica, 1070
- Hopital Erasme
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Brussels, Bélgica, 1000
- CHU Saint-Pierre
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Ghent, Bélgica, 9000
- Universitair Ziekenhuis Gent
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Roeselare, Bélgica, 8800
- Algemeen Ziekenhuis Delta
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Ontario
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London, Ontario, Canadá, N6A 5A5
- London Health Sciences Centre
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North Bay, Ontario, Canadá, P1B 2H3
- North Bay Dermatology Centre
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Brno, Chequia, 636 00
- Fakultni nemocnice Brno
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Hradec Králové, Chequia, 500 05
- Fakultni nemocnice Hradec Kralove
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Kladno, Chequia, 27259
- Oblastni nemocnice Kladno a.s.
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Prague, Chequia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Slaný, Chequia, 274 01
- Nemocnice Slany
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Busan, Corea del Sur, 41404
- Kyungpook National University Chilgok Hospital
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Busan, Corea del Sur, 48108
- Inje University Haeundae Paik Hospital
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Busan, Corea del Sur, 49267
- Kosin University Gospel Hospital
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Busan, Corea del Sur, 602739
- DongA Medical Center
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Daegu, Corea del Sur, 42415
- Yeungnam University Medical Center
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Daejeon, Corea del Sur, 34943
- The Catholic University of Korea Seoul St.Mary's Hospital
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Dongdaemun-gu, Corea del Sur, 02447
- Kyung Hee University Hospital
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Goyang-si, Corea del Sur, 10326
- Dongguk University Ilsan Hospital
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Gwangju, Corea del Sur, 61469
- Chonnam National University Hospital
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Gyeonggi-do, Corea del Sur, 13496
- CHA Bundang Medical Center, CHA University
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Gyeonggi-do, Corea del Sur, 16247
- The Catholic university of Korea, St. Vincent's Hospital
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Seoul, Corea del Sur, 06351
- Samsung Medical Center
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Seoul, Corea del Sur, 03181
- Kangbuk Samsung Hospital
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Seoul, Corea del Sur, 03722
- Yonsei University College of Medicine
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Seoul, Corea del Sur, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Suwon, Corea del Sur, 16499
- Ajou University Hospital
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Wŏnju, Corea del Sur, 26426
- Wonju Christian Hospital
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Yangch’ŏn-gu, Corea del Sur, 07985
- Ewha Womans University Mokdong Hospital
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Bjelovar, Croacia, 43000
- Opca bolnica Bjelovar
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Split, Croacia, 21000
- University Hospital Center Split
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Zadar, Croacia, 23000
- Opca bolnica Zadar
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Zagreb, Croacia, 10000
- Poliklinika Solmed
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Esbjerg, Dinamarca, 6700
- Sydvestjysk Sygehus
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Hilleroed, Dinamarca, 3400
- Nordsjaellands Hospital - Hillerod
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Banská Bystrica, Eslovaquia, 974 01
- FNsP F.D.R. Banska Bystrica
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Košice, Eslovaquia, 040 13
- ENDOMED s.r.o
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Prešov, Eslovaquia, 080 01
- GASTRO I. s.r.o.
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Gijón, España, 33394
- Hosp. de Cabuenes
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Huelva, España, 21005
- Hosp. Gral. Juan Ramon Jimenez
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Huelva, España, 21002
- Hosp. Gral. Juan Ramon Jimenez 1
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Madrid, España, 28031
- Hosp. Univ. Infanta Leonor
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Seville, España, 41009
- Hosp. Virgen Macarena
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Vigo, España, 36213
- Hosp. Alvaro Cunqueiro
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Villajoyosa, España, 03570
- Hosp. de La Marina Baixa
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Alabama
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Dothan, Alabama, Estados Unidos, 36305
- Digestive Health Specialists of the Southeast
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Arizona
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Chandler, Arizona, Estados Unidos, 85224-1636
- Advanced Gastro P.C
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Scottsdale, Arizona, Estados Unidos, 85260
- Reliance Research
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205-6414
- Moore Clinical Trials, LLC
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Little Rock, Arkansas, Estados Unidos, 72223
- Central Arkansas Veterans Healthcare System
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California
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Anaheim, California, Estados Unidos, 92805
- Clinnova Research
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Lancaster, California, Estados Unidos, 93534
- Om Research LLC
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Lancaster, California, Estados Unidos, 93534
- Om Research LLC 1
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Los Alamitos, California, Estados Unidos, 90720
- United Gastroenterologists
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Los Angeles, California, Estados Unidos, 90048
- Paul Wallace MD
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Pasadena, California, Estados Unidos, 77505-3950
- Digestive System Healthcare
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San Diego, California, Estados Unidos, 92103
- Clinical Applications Laboratories, Inc
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San Diego, California, Estados Unidos, 92103-2120
- Northshore Gastroenterology Research, LLC
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Santa Maria, California, Estados Unidos, 93454
- Santa Maria Gastroenterology
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Walnut Creek, California, Estados Unidos, 94598
- Clinical Research of California
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Colorado
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Grand Junction, Colorado, Estados Unidos, 81505-1027
- Amel Med LLC Research
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Connecticut
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Danbury, Connecticut, Estados Unidos, 06810
- Western Connecticut Health Network/Danbury Hospital
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Florida
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Clearwater, Florida, Estados Unidos, 33762-5323
- Gastroenterology Associates of SW Florida
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Coconut Creek, Florida, Estados Unidos, 33066
- Pioneer Research Solutions Inc.
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DeBary, Florida, Estados Unidos, 32713
- Omega Research Consultants
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Hialeah, Florida, Estados Unidos, 33016
- Harmony Medical Research Institute, Inc.
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Kissimmee, Florida, Estados Unidos, 34741
- Central Florida Gastro Research
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Miami, Florida, Estados Unidos, 33155
- Community Research Foundation, Inc.
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Naples, Florida, Estados Unidos, 34102
- Gastroenterology Group Of Naples
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Orlando, Florida, Estados Unidos, 32803-1853
- Center for Digestive Health
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Orlando, Florida, Estados Unidos, 32819
- Central Florida Internists
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St. Petersburg, Florida, Estados Unidos, 33705
- Synergy Clinical Research
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Georgia
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Atlanta, Georgia, Estados Unidos, 30328
- Agile Clinical Research Trials, LLC
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Atlanta, Georgia, Estados Unidos, 30224
- Atlanta Gastroenterology Specialists, PC
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Decatur, Georgia, Estados Unidos, 30033
- Atlanta Center For Gastroenterology
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Macon, Georgia, Estados Unidos, 31201
- Gastroenterolgy Associates of Central GA
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Roswell, Georgia, Estados Unidos, 30076-4943
- Gastroenterology Consultants
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Idaho
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Boise, Idaho, Estados Unidos, 83706
- USF Asthma, Allergy, Immunology Clinical Research Unit
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Idaho Falls, Idaho, Estados Unidos, 83404
- Grand Teton Research Group, PLLC
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Illinois
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Oakbrook Terrace, Illinois, Estados Unidos, 60618
- Lemah Creek Clinical Research
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Kansas
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Kansas City, Kansas, Estados Unidos, 66103-2937
- University of Kansas Medical Center
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Leawood, Kansas, Estados Unidos, 66211
- BVL Clinical Research
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Topeka, Kansas, Estados Unidos, 66606
- Cotton O'Neil Digestive Health Center
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Kentucky
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Crestview Hills, Kentucky, Estados Unidos, 41017
- Tri-State Gastroenterology Assoc
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Louisiana
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Marrero, Louisiana, Estados Unidos, 70072
- Tandem Clinical Research
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Maryland
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Baltimore, Maryland, Estados Unidos, 21202-2102
- Institute for Digestive Health and Liver Disease
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Glen Burnie, Maryland, Estados Unidos, 21061
- Woodholme Gastroenterology Associates
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Massachusetts
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Chelmsford, Massachusetts, Estados Unidos, 01824
- Digestive Health Specialists PC
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South Dartmouth, Massachusetts, Estados Unidos, 02747
- FC Research, LLC
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Michigan
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Chesterfield, Michigan, Estados Unidos, 48047
- Clinical Research Institute of Michigan, LLC
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Livonia, Michigan, Estados Unidos, 48152
- Detroit Clinical Research Center
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216
- University of Mississippi Medical Center
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New York
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Brooklyn, New York, Estados Unidos, 11203
- SUNY Downstate Medical Center
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Jackson Heights, New York, Estados Unidos, 11372
- Smart Medical Research
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Middletown, New York, Estados Unidos, 10941
- Crystal Run Healthcare LLP
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New York, New York, Estados Unidos, 10075
- New York Gastroenterology Associates
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North Massapequa, New York, Estados Unidos, 11758
- DiGiovanna Institute for Medical Education & Research
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Queens, New York, Estados Unidos, 11375
- A1 Clinical Network
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28207
- Carolinas Medical Center
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Charlotte, North Carolina, Estados Unidos, 28277
- Onsite Clinical Solutions
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Greenville, North Carolina, Estados Unidos, 27834
- Carolina Research
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Gastroenterology Associates of the Piedmont, P.A.
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Ohio
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Columbus, Ohio, Estados Unidos, 43214
- Central Ohio Endoscopy Center LLC
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Dayton, Ohio, Estados Unidos, 45440
- Dayton Gastroenterology, Inc
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Mentor, Ohio, Estados Unidos, 44060
- Great Lakes Gastroenterology
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Oklahoma University Health Science Center
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Oklahoma City, Oklahoma, Estados Unidos, 73112
- Integris Baptist Office
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Oklahoma City, Oklahoma, Estados Unidos, 73120
- Central Sooner Research
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Tulsa, Oklahoma, Estados Unidos, 74137-7061
- Essential Medical Research
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Oregon
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Portland, Oregon, Estados Unidos, 97220-9428
- The Oregon Clinic
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Pennsylvania
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Smithfield, Pennsylvania, Estados Unidos, 15478
- Frontier Clinical Research
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29615
- Gastroenterology Associates P.A.
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Myrtle Beach, South Carolina, Estados Unidos, 29572
- Carolina Health Specialists
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Texas
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Lubbock, Texas, Estados Unidos, 79424
- West Texas Clinical Research
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Richmond, Texas, Estados Unidos, 77407
- Victoria Gastroenterology
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San Antonio, Texas, Estados Unidos, 78229
- Gastroenterology Clinic Of San Antonio P A
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San Antonio, Texas, Estados Unidos, 78232
- Wellness Clinical Research
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Southlake, Texas, Estados Unidos, 76092
- Texas Digestive Disease Consultants
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Tyler, Texas, Estados Unidos, 75701
- Digestive Health Specialists of Tyler
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Utah
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Salt Lake City, Utah, Estados Unidos, 84124
- Care Access Research- Salt Lake City
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Virginia
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Burke, Virginia, Estados Unidos, 22015
- Burke Internal Medicine and Research
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Chesapeake, Virginia, Estados Unidos, 23320
- Gastroenterology Associates of Tidewater
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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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Budapest, Hungría, 1036
- Obudai Egeszsegugyi Centrum Kft
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Budapest, Hungría, H-1088
- Semmelweis Egyetem
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Budapest, Hungría, H-1136
- Pannónia Magánorvosi Centrum Kft
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Budapest, Hungría, 1097
- Egyesített Szent István és Szent László Kórház
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Budapest, Hungría, 1126
- Mh Egészségügyi Központ
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Budapest, Hungría, 1125
- Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
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Kistarcsa, Hungría, 2143
- Pest Megyei Flor Ferenc Korhaz
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Mohács, Hungría, 7700
- Mohacsi Korhaz
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Pécs, Hungría, 7624
- Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
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Szombathely, Hungría, H-9700
- Markusovszky Egyetemi Oktatokorhaz
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Afula, Israel, 1834111
- Haemek Medical Center
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Beersheba, Israel, 84101
- Soroka University Medical Center
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Ramat Gan, Israel, 5265601
- The Chaim Sheba Medical Center
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Rehovot, Israel, 76100
- Kaplan Medical Center
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Tzrifin, Israel, 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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Bunkyō City, Japón, 113-8431
- Juntendo University Hospital
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Chūōku, Japón, 1040061
- Ginza central clinic
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Fukui-ken, Japón, 910-8526
- Fukui Prefectural Hospital
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Fukuoka, Japón, 814-0180
- Fukuoka University Hospital
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Fukuoka, Japón, 815-8555
- Japanese Red Cross Fukuoka Hospital
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Fukuyama, Japón, 720-8520
- National Hospital Organization Fukuyama Medical Center
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Gamagōri, Japón, 443-8501
- Gamagori City Hospital
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Gunma, Japón, 371-0034
- Gunma University Hospital
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Hachinohe, Japón, 031-8555
- Hachinohe City Hospital
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Hamamatsu, Japón, 431 3192
- Hamamatsu University Hospital
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Hamamatsu, Japón, 432-8061
- Matsuda Hospital
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Higashi-Ibaraki, Japón, 311-3193
- National Hospital Organization Mito Medical Center
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Hiroshima, Japón, 737-8505
- Kure Kyosai Hospital
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Iizuka-shi, Japón, 820-8505
- National Hospital Organization Shikoku Cancer Center
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Kagoshima, Japón, 890-8520
- Kagoshima University Hospital
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Kagoshima, Japón, 892-0843
- Kagoshima IBD Gastroenterology Clinic
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Kashiwa, Japón, 277-0871
- Tsujinaka Hospital Kashiwanoha
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Kitakyushu, Japón, 800-0229
- Kyushu Rosai Hospital
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Kobe, Japón, 650 0017
- Kobe University Hospital
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Kofu, Japón, 400-8506
- Yamanashi Prefectural Central Hospital
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Koshigaya, Japón, 343-8555
- Dokkyo Medical University Saitama Medical Center
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Kurume, Japón, 839-0809
- Hidaka Coloproctologic Clinic
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Kyoto, Japón, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Kyoto, Japón, 602-8026
- Japanese Red Cross Kyoto Daini Hospital
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Morioka, Japón, 020-8505
- Iwate Medical University Hospital
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Nagasaki, Japón, 852-8501
- Nagasaki University Hospital
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Nagoya, Japón, 460-0022
- Yokoyama IBD Clinic
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Nakagami-gun, Japón, 901-2132
- University of the Ryukyus Hospital
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Niigata, Japón, 951 8520
- Niigata University Medical And Dental Hospital
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Nishinomiya, Japón, 663-8014
- Nishinomiya Municipal Central Hospital
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Osaka, Japón, 540-0006
- National Hospital Organization Osaka National Hospital
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Osaka, Japón, 558-8558
- Osaka General Medical Center
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Osaka, Japón, 543-8555
- Japanese Red Cross Osaka Hospital
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Osaka, Japón, 530-0011
- Kinshukai Infusion Clinic
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Sapporo, Japón, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Sendai, Japón, 981-3213
- Takagi Clinic
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Sunto-gun, Japón, 411-8611
- National Hospital Organization Shizuoka Medical Center
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Tokyo, Japón, 160-0023
- Tokyo Medical University Hospital
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Toyota, Japón, 470-0396
- Toyota Kosei Hospital
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Yokohama, Japón, 232 0024
- Yokohama City University Medical Center
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Ōita, Japón, 870-0033
- Oita Red Cross Hospital
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Ōtsu, Japón, 520-2192
- Shiga University of Medical Science Hospital
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Amman, Jordán, 11183
- Khalidi Hospital and Medical Center
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Amman, Jordán, 11194
- The Speciality Hospital (TSH) / Advanced Clinical Center
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Amman, Jordán, 11196
- Istiklal Hospital
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Amman, Jordán, 1184
- Abdali Hospital
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Irbid, Jordán, 21110
- Irbid Specialty Hospital
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Irbid, Jordán, 22110
- Pharmaceutical Research Center Jordan University of Science and Technology Rheumatology
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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, Malasia, 80100
- Hospital Sultanah Aminah
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Kota Bharu, Malasia, 16150
- Hospital University Sains Malaysia
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Kota Kinabalu, Malasia, 88586
- Hospital Raja Permaisuri Bainun
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Kuala Lumpur, Malasia, 59100
- University Malaya Medical Centre
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Kuantan, Malasia, 25100
- Hospital Tengku Ampuan Afzan
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Christchurch, Nueva Zelanda, 8011
- Christchurch Hospital
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Dunedin, Nueva Zelanda, 9016
- Dunedin Hospital
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Amsterdam, Países Bajos, 1091 AC
- Onze Lieve Vrouwe Gasthuis
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Rotterdam, Países Bajos, 3045 PM
- Sint Franciscus Gasthuis
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Tilburg, Países Bajos, 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
-
Chojnice, Polonia, 89-600
- Centrum Medyczne Lukamed
-
Chojnice, Polonia, 89 600
- Centrum Medyczne Lukamed Sp z o o
-
Chrzanów, Polonia, 32-500
- Sahlgrenska University Hospital
-
Knurów, Polonia, 44 190
- MZ Badania Slowik Zymla Spolka jawna
-
Krakow, Polonia, 30 149
- Malopolskie Centrum Kliniczne
-
Krakow, Polonia, 30 363
- Centrum Medyczne Plejady
-
Krakow, Polonia, 31 637
- Centrum Medyczne ProMiMed
-
Lodz, Polonia, 90-752
- IP Clinic Sp. z o.o.
-
Lodz, Polonia, 91 034
- Centrum Medyczne Med Gastr
-
Lodz, Polonia, 90-644
- AmiCare Centrum Medyczne
-
Lublin, Polonia, 20-412
- ETG Lublin
-
Lublin, Polonia, 20 582
- REUMED Zespol Poradni Specjalistycznych Filia nr 2
-
Nowy Targ, Polonia, 34 400
- Allmedica
-
Olsztyn, Polonia, 10 561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
-
Opole, Polonia, 45-819
- Twoja Przychodnia 1
-
Piotrkow Trybunalski, Polonia, 97 300
- Centrum Medyczne
-
Poznan, Polonia, 60 309
- EMC Instytut Medyczny SA PL CERTUS
-
Poznan, Polonia, 61 441
- Synexus Polska Sp z o o
-
Poznan, Polonia, 61 324
- Twoja Przychodnia
-
Rzeszów, Polonia, 35-326
- Centrum Medyczne Medyk
-
Skorzewo, Polonia, 60-185
- Centrum Medyczne Promed
-
Sopot, Polonia, 81-756
- Endoskopia Sp z o.o.
-
Sosnowiec, Polonia, 41-200
- Kiepury Clinic
-
Straszów, Polonia, 28 200
- KO Med Centrum Medyczne
-
Szczecin, Polonia, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
-
Szczecin, Polonia, 71-685
- Sonomed Sp. z o.o.
-
Torun, Polonia, 87 100
- GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
-
Tychy, Polonia, 43-100
- H-T Centrum Medyczne Endoterapia
-
Warsaw, Polonia, 02-507
- Centralny Szpital Kliniczny MSWiA w Warszawie
-
Warsaw, Polonia, 02 653
- Endoterapia
-
Warsaw, Polonia, 00 632
- Centrum Zdrowia Matki Dziecka i Mlodziezy
-
Warsaw, Polonia, 02 798
- Medical Concierge Centrum Medyczne
-
Warsaw, Polonia, 03 580
- NZOZ Vivamed
-
Warsaw, Polonia, 03-712
- Gabinety Lekarskie Bodyclinic
-
Warsaw, Polonia, 04-501
- IBD Point Profesor Kierkus
-
Wierzchosławice, Polonia, 33-122
- Centrum Zdrowia Tuchow
-
Wroclaw, Polonia, 50-556
- Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
-
Wroclaw, Polonia, 53 149
- Przychodnia Vistamed
-
Wroclaw, Polonia, 53 611
- Centrum Medyczne Melita Medical
-
Wroclaw, Polonia, 50-449
- Centrum Medyczne Melita Medical 2
-
Włocławek, Polonia, 87-800
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
-
Zamość, Polonia, 22-400
- Pro Life Medica Sp z o o ETG Zamosc
-
-
-
-
-
Bengbu, Porcelana, 233004
- The Affiliated Hospital of Bengbu Medical College
-
Changsha, Porcelana, 410008
- Xiangya Hospital Central South University
-
Changsha, Porcelana, 410011
- The second Xiangya Hospital of Central South University
-
Changzhou, Porcelana, 213004
- Changzhou No 2 Peoples Hospital
-
Chengdu, Porcelana, 610041
- West China Hospital Sichuan University
-
Chongqing, Porcelana, 400013
- Chongqing Medical University
-
Foshan, Porcelana, 528010
- The First People's Hospital of Foshan
-
Fuzhou, Porcelana, 350005
- The First Affiliated Hospital of Fujian Medical University
-
Ganzhou, Porcelana, 341000
- First Affiliated Hospital of Gannan Medical University
-
Guangzhou, Porcelana, 510180
- Guangzhou First Municipal People's Hospital
-
Guangzhou, Porcelana, 510080
- Guangdong Provincial People's Hospital
-
Guangzhou, Porcelana, 510260
- Guangzhou Medical University
-
Hangzhou, Porcelana, 310006
- Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
-
Hangzhou, Porcelana, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
-
Hefei, Porcelana, 230022
- The First Affiliated Hospital of Anhui Medical University
-
Nanchang, Porcelana, 330006
- The First Affiliated Hospital of NanChang University
-
Nanjing, Porcelana, 210008
- Nanjing Drum Tower Hospital
-
Nanjing, Porcelana, 210006
- Nanjing 1st Hospital
-
Quanzhou, Porcelana, 362002
- The First Hospital of Quanzhou
-
Shanghai, Porcelana, 200040
- Huashan Hospital Fudan University
-
Shanghai, Porcelana, 200120
- Shanghai East Hospital
-
Shenyang, Porcelana, 110022
- Shengjing Hospital Of China Medical University
-
Suzhou, Porcelana
- The first affiliated hospital of suzhou University
-
Wuxi, Porcelana, 214023
- Wuxi People s Hospital
-
Yangzhou, Porcelana, 225001
- Yangzhou First People's Hospital
-
Zhuzhou, Porcelana, 412007
- ZhuZhou Central Hospital
-
-
-
-
-
Kaoshiung, Taiwán, 80756
- Kaohsiung Medical University Chung Ho Memorial Hospital
-
Taichung, Taiwán, 40447
- China Medical University Hospital
-
Taipei, Taiwán, 100
- National Taiwan University Hospital, Division of Infectious Diseases
-
Taipei, Taiwán, 110301
- Taipei Medical University
-
Taoyuan, Taiwán, 33305
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Ankara, Turquía (Türkiye), 06100
- Ankara Numune Egitim ve Arastirma Hastanesi
-
Ankara, Turquía (Türkiye), 06230
- Hacettepe University Hospital
-
Ankara, Turquía (Türkiye), 06560
- Gazi University Medical Faculty
-
Istanbul, Turquía (Türkiye), 34349
- Acibadem Fulya Hospital
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Izmir, Turquía (Türkiye), 35040
- Ege Universitesi Tip Fakultesi
-
Mersin, Turquía (Türkiye), 33343
- Mersin University Medical Faculty
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Samsun, Turquía (Türkiye), 55420
- Ondokuz Mayis University
-
Zonguldak, Turquía (Türkiye), 67000
- Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
|
Experimental: 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. |
|
Comparador de placebos: Group 3: Placebo
Participants will receive placebo injection subcutaneously. |
Placebo will be administered by SC injection. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission at Week 12
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission at Week 24
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de enero de 2022
Finalización primaria (Actual)
4 de julio de 2023
Finalización del estudio (Estimado)
30 de octubre de 2028
Fechas de registro del estudio
Enviado por primera vez
17 de enero de 2022
Primero enviado que cumplió con los criterios de control de calidad
17 de enero de 2022
Publicado por primera vez (Actual)
19 de enero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR109125
- 2020-006165-11 (Número EudraCT)
- CNTO1959CRD3004 (Otro identificador: Janssen Research & Development, LLC)
- 2023-504737-41-00 (Identificador de registro: EUCT number)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .