중등도에서 중증의 활동성 궤양성 대장염 환자를 대상으로 구셀쿠맙과 골리무맙 병용 요법에 관한 연구 (DUET-UC)
2026년 11월 2일 업데이트: Janssen Research & Development, LLC
중등도에서 중증의 활동성 궤양성 대장염 환자를 대상으로 Guselkumab 및 Golimumab을 사용한 유도 및 유지 병용 요법의 효능과 안전성을 평가하기 위한 2b상 무작위, 이중 맹검, 활성 및 위약 대조, 병렬 그룹, 다기관 연구
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.
연구 개요
상태
모집하지 않고 적극적으로
정황
연구 유형
중재적
등록 (실제)
577
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Athens, 그리스, 11528
- Alexandra General Hospital of Athens
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Athens, 그리스, 115 27
- Sotiria General State Hospital of Chest Diseases
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Piraeus, 그리스, 184 54
- Nikaia General Hospital
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Thessaloniki, 그리스, 54642
- Hippokration Hospital
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Benoni, 남아프리카, 1501
- Worthwhile Clinical Trials Lakeview Hospital
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Cape Town, 남아프리카, 7925
- Groote Schur Hospital
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Cape Town, 남아프리카, 7500
- Mediclinic Panorama
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Johannesburg, 남아프리카, 1827
- Practice Dr Naeem Moosa
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Pretoria, 남아프리카, 0002
- Emmed Research
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Amsterdam, 네덜란드, 105 AZ
- Academisch Medisch Centrum Universiteit van Amsterdam
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Dordrecht, 네덜란드, 3318 AT
- Albert Schweitzer Ziekenhuis
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Maastricht, 네덜란드, 6229 HX
- Maastricht University Medical Centre
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Rotterdam, 네덜란드, 3015 GD
- Erasmus Medisch Centrum
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Utrecht, 네덜란드, 3584 CX
- UMC Utrecht
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Gjettum, 노르웨이, 1346
- Vestre Viken HF Baerum Sykehus
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Gjøvik, 노르웨이, 2819
- Sykehuset Innlandet HF Gjøvik
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Lørenskog, 노르웨이, 1478
- Akershus Universitetssykehus
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Oslo, 노르웨이, 0450
- Oslo University Hospital HF Ulleval sykehus
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Tromsø, 노르웨이, N-9038
- Universitetssykehuset Nord-Norge HF
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Ålesund, 노르웨이, 6010
- Alesund sjukehus
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Christchurch, 뉴질랜드, 8140
- Christchurch Hospital
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Dunedin, 뉴질랜드, 9016
- Dunedin Hospital
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Lower Hutt, 뉴질랜드, 5010
- Hutt Hospital
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Wellington, 뉴질랜드, 6021
- Wellington Hospital
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Changhua, 대만, 500
- Changhua Christian Hospital
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Taichung, 대만, 40447
- China Medical University Hospital
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Taichung, 대만, 407204
- Taichung Veterans General Hospital
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Tainan, 대만, 70403
- National Cheng Kung University Hospital
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Taipei, 대만, 100
- National Taiwan University Hospital, Division of Infectious Diseases
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Taoyuan, 대만, 33305
- Chang-Gung Memorial Hospital, LinKou Branch
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Busan, 대한민국, 48108
- Inje University Haeundae Paik Hospital
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Busan, 대한민국, 49267
- Kosin University Gospel Hospital
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Daegu, 대한민국, 42415
- Yeungnam University Hospital
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Gwangju, 대한민국, 61453
- Chosun university hospital
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Gyeonggi-do, 대한민국, 16247
- The Catholic university of Korea, St. Vincent's Hospital
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Hwaseong-si, 대한민국, 18450
- Hallym University Dongtan Sacred Heart Hospital
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Seoul, 대한민국, 05505
- Asan Medical Center
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Seoul, 대한민국, 03722
- Severance Hospital Yonsei University Health System
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Seoul, 대한민국, 03181
- Kangbuk Samsung Hospital
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Seoul, 대한민국, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, 대한민국, 130 050
- Kyung Hee University Hospital
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Seoul, 대한민국, 6591
- The Catholic University of Korea Seoul St.Marys Hospital 1
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Seoul, 대한민국, 06591
- The Catholic University of Korea Seoul St.Mary's Hospital
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Suwon, 대한민국, 16499
- Ajou University Hospital
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Wŏnju, 대한민국, 26426
- Yonsei University Wonju Severance Christian Hospital
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Aalborg, 덴마크, 9000
- Aalborg Hospital
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Aarhus, 덴마크
- Aarhus University Hospital
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Copenhagen, 덴마크, 2400
- Bispebjerg Og Frederiksberg Hospital
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Herlev, 덴마크, 2730
- Herlev Hospital, University of Copenhagen
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Odense, 덴마크, 5000
- Odense Universitetshospital
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Berlin, 독일, 10117
- Charite Universitaetsmedizin Berlin - Campus Charite Mitte
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Berlin, 독일, 14163
- Krankenhaus Waldfriede Mitte
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Berlin, 독일, 12203
- Charite - Universitaetsmedizin Berlin (CCM)
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Berlin, 독일, 10825
- Praxis Fur Gastroenteroligie
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Dresden, 독일, 1307
- University Hospital Dresden
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Erlangen, 독일, 91054
- Universitaetsklinik Erlangen
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Frankfurt, 독일, 69590
- JWG-University Hospital
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Frankfurt am Main, 독일, 60431
- Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
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Freiburg im Breisgau, 독일, 79106
- Universitatsklinikum Freiburg
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Fulda, 독일, 36043
- Klinikum Fulda - Tumorklinik - Germany
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Halle, 독일, 06097
- Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk
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Halle, 독일, 06108
- Studiengesellschaft Mitteldeutschland GmbH
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Hanover, 독일, 30625
- Medizinische Hochschule Hannover
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Heidelberg, 독일, 69120
- University Hospital Heidelberg
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Heidelberg, 독일, 69115
- Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd
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Jena, 독일, 07747
- Universitatsklinikum Jena
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Jerichow, 독일, 39319
- Praxisgemeinschaft Jerichow
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Karlshorst, 독일, 10318
- Gastroenterologische Spezialpraxis - Berlin-Karlshorst
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Leipzig, 독일, 04103
- Eugastro GmbH
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Lüneburg, 독일, 21339
- Staedtisches Klinikum Lueneburg
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Mannheim, 독일, 68167
- Universitaetsklinikum Mannheim
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Minden, 독일, 32423
- Gastroenterologische Gemeinschaftspraxis Minden
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Munich, 독일, 81377
- Klinikum der Universitaet Muenchen
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Münster, 독일, 48155
- MVZ Portal 10
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Münster, 독일, 48149
- Praxis fur Innere Medizin und Gastroenterologie
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Nürtingen, 독일, 72622
- Medius Klinik Nurtingen
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Pforzheim, 독일, 75179
- Siloah St Trudpert Klinikum
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Saarbrücken, 독일, 66111
- Zentrum für Gastroenterologie Saar MVZ GmbH
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Tübingen, 독일, 72076
- Universitaetsklinik Tuebingen
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Ulm, 독일, 89070
- Universitatsklinikum Ulm
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Wipperfürth, 독일, 51688
- Gemeinschaftspraxis Jakobeit
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Würzburg, 독일, 97080
- Universitatsklinikum Wurzburg
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California
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Arcadia, California, 미국, 91006
- Valley Gastroenterology Medical Group
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Coronado, California, 미국, 92118
- Southern California Research Center
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Lancaster, California, 미국, 93534
- Om Research LLC
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Los Angeles, California, 미국, 90048
- Cedars Sinai Medical Center
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San Francisco, California, 미국, 94115
- University of California San Francisco
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado
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Colorado Springs, Colorado, 미국, 80907
- Peak Gastroenterology Associates
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Connecticut
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Hamden, Connecticut, 미국, 06518
- Medical Research Center of Connecticut
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New Haven, Connecticut, 미국, 06510
- Yale University
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20007
- MedStar Georgetown University Hospital
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Florida
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Coconut Creek, Florida, 미국, 33066
- Pioneer Research Solutions Inc.
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Kissimmee, Florida, 미국, 34741
- Digestive and Liver Disease Institute
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Kissimmee, Florida, 미국, 34741
- Osceola Regional Hospital
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Lakewood Rch, Florida, 미국, 34211
- Florida Research Center Inc.
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Miami, Florida, 미국, 33136
- University of Miami
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Naples, Florida, 미국, 34102
- Gastroenterology Group Of Naples
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Orlando, Florida, 미국, 32808
- Omega Research Consultants
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St. Petersburg, Florida, 미국, 33705
- Synergy Clinical Research
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Tampa, Florida, 미국, 33609
- GCP Clinical Research
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Georgia
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Atlanta, Georgia, 미국, 30342
- Atlanta Gastroenterology Associates
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Macon, Georgia, 미국, 31201
- Gastroenterolgy Associates of Central GA
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Marietta, Georgia, 미국, 30060
- Gastrointestinal Specialists of Georgia
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Marietta, Georgia, 미국, 30060
- Atlanta Gastroenterology Associates 1
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Roswell, Georgia, 미국, 30076
- Gastroenterology Consultants
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Idaho
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Idaho Falls, Idaho, 미국, 83404
- Grand Teton Gastroenterology
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Indiana
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Indianapolis, Indiana, 미국, 46202
- IU Health University Hospital
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New Albany, Indiana, 미국, 47150
- Gastroenterology of Southern Indiana
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Kentucky
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Crestview Hills, Kentucky, 미국, 41017
- Tri-State Gastroenterology Assoc
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Lexington, Kentucky, 미국, 40536
- University of Kentucky Chandler Medical Center
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Louisville, Kentucky, 미국, 40202
- Jewish Hospital
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Maryland
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Chevy Chase, Maryland, 미국, 20815-7313
- Chevy Chase Clinical Research
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Massachusetts
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Boston, Massachusetts, 미국, 02215-5400
- Beth Israel Deaconess Medical Center
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Chestnut Hill, Massachusetts, 미국, 02467
- Brigham And Women's Hospital
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Michigan
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Ypsilanti, Michigan, 미국, 48197
- Huron Gastroenterology Associates Center for Digestive Care
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Missouri
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St Louis, Missouri, 미국, 63110
- Washington University
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Nevada
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Las Vegas, Nevada, 미국, 89113
- Las Vegas Medical Research
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Las Vegas, Nevada, 미국, 89148
- Care Access Las Vegas
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756
- Dartmouth Hitchcock
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New York
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New York, New York, 미국, 10021
- Weill Cornell Medical College
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New York, New York, 미국, 10075
- Lenox Hill Hospital
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Utica, New York, 미국, 13502-6313
- Mohawk Valley Endoscopy Center
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- University North Carolina at Chapel Hill
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Charlotte, North Carolina, 미국, 28277
- Onsite Clinical Solutions
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Charlotte, North Carolina, 미국, 28210
- Tryon Medical Group
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Kinston, North Carolina, 미국, 28501
- Care Access Research, Kinston
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Ohio
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Mentor, Ohio, 미국, 44060
- Great Lakes Gastroenterology Research, LLC
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Pennsylvania
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Uniontown, Pennsylvania, 미국, 15401
- Frontier Clinical Research
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South Carolina
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Charleston, South Carolina, 미국, 29425
- Medical University of South Carolina
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Rock Hill, South Carolina, 미국, 29732
- Digestive Disease Associates
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Tennessee
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Germantown, Tennessee, 미국, 38138
- Gastro One
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Johnson City, Tennessee, 미국, 37604
- Etsu Quillen College Of Medicine
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Nashville, Tennessee, 미국, 37067
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, 미국, 75390-9063
- UT Southwestern Medical Center
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Houston, Texas, 미국, 77346
- GI Specialists of Houston
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San Antonio, Texas, 미국, 78229
- Gastroenterology Clinic Of San Antonio P A
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Southlake, Texas, 미국, 76092
- Texas Digestive Disease Consultants
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Tyler, Texas, 미국, 75701
- Tyler Research Institute, LLC
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Virginia
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Richmond, Virginia, 미국, 23249
- Medical College Of Virginia Hospital
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Washington
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Bellevue, Washington, 미국, 98004
- Washington Gastroenterology, PLLC
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Seattle, Washington, 미국, 98111
- Virginia Mason Medical Center
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Seattle, Washington, 미국, 98104
- Swedish Medical Center
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Tacoma, Washington, 미국, 98405
- Digestive Health Specialists
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226-3522
- Medical College Of Wisconsin
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Bonheiden, 벨기에, 2820
- Imelda Ziekenhuis
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Bruges, 벨기에, 8000
- Algemeen Ziekenhuis Sint-Jan
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Brussels, 벨기에, 1200
- Cliniques Universitaires Saint Luc
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Ghent, 벨기에, 9000
- AZ Maria Middelares
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Ghent, 벨기에, 9000
- UZ Gent
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Leuven, 벨기에, 3000
- UZ Leuven
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Liège, 벨기에, 4000
- CHU de Liege
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Liège, 벨기에, 4000
- CHC MontLegia
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Sint-Niklaas, 벨기에
- Vitaz
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Haskovo, 불가리아, 6300
- Medical Centre Hipocrat
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Sliven, 불가리아, 8800
- Diagnostic Consulting Center I Sliven
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Sofia, 불가리아, 1527
- UMHAT 'Tsaritsa Yoanna'
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Sofia-Grad, 불가리아, 1431
- University Hospital Alexandrovska - Clinic of Nephrology
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Veliko Tarnovo, 불가리아, 5000
- Medical Center -Medika Plus
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Vratsa, 불가리아, 3000
- Multriprofile Hospital for Active Treatment Hristo Botev
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Botucatu, 브라질, 18618-970
- Universidade Estadual Paulista 'Julio De Mesquita Filho'
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Brasília, 브라질, 70200-730
- L2IP Instituto de Pesquisas Clinicas
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Brasília, 브라질, 72145-450
- Chronos Clinica Medica LTDA Chronos Pesquisa Clinica
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Caxias do Sul, 브라질, 95070-560
- Fundacao Universidade de Caxias do Sul
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Curitiba, 브라질, 80430-180
- Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica
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Porto Alegre, 브라질, 90035-903
- Hospital das Clinicas de Porto Alegre
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Porto Alegre, 브라질, 90035-001
- Associacao Hospitalar Moinhos de Vento
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Porto Alegre, 브라질, 90035-003
- Hospital De Clinicas De Porto Alegre
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Rio de Janeiro, 브라질, 21941-913
- Universidade Federal do Rio de Janeiro - Faculdade de Medicina
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Salvador, 브라질, 40150 150
- SER - Servicos Especializados em Reumatologia da Bahia
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Santo André, 브라질, 09080-110
- Pesquisare Saude
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Santos, 브라질, 11075-101
- Irmandade da Santa Casa da Misericórdia de Santos
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São Paulo, 브라질, 03325-050
- BR Trials
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São Paulo, 브라질, 04502-001
- Instituto D Or de Pesquisa e Ensino IDOR
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São Paulo, 브라질, 04039-004
- Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
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São Paulo, 브라질, 01409 902
- Hospital Nove de Julho
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Solna, 스웨덴, 171 76
- Karolinska Universitetssjukhuset Solna
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Stockholm, 스웨덴, 116 91
- Ersta sjukhus
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Basel, 스위스, 4031
- Universitatsspital Basel
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Bern, 스위스, 3010
- Inselspital Universitatsspital Bern
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Bern, 스위스, 3012
- Gastroenterologische Praxis Balsiger und Seibold
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Sankt Gallen, 스위스, 9007
- Kantonsspital St Gallen
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Zurich, 스위스, 8091
- UniversitaetsSpital Zuerich
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Barcelona, 스페인, 08036
- Hosp Clinic de Barcelona
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Madrid, 스페인, 28046
- Hosp. Univ. La Paz
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Pamplona, 스페인, 31008
- Hosp. de Navarra
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Pontevedra, 스페인, 36071
- Hosp. Montecelo
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Sabadell, 스페인, 8208
- Corporacio Sanitari Parc Tauli
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Santander, 스페인, 39008
- Hosp. Univ. Marques de Valdecilla
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Torrejón de Ardoz, 스페인, 28850
- Hosp. Univ. de Torrejon
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Vigo, 스페인, 36213
- Hosp. Alvaro Cunqueiro
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Banská Bystrica, 슬로바키아, 974 01
- FNsP F.D.R. Banska Bystrica
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Bratislava, 슬로바키아, 811 09
- Cliniq s.r.o.
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Prešov, 슬로바키아, 080 01
- GASTRO I. s.r.o.
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Vranov nad Topľou, 슬로바키아, 093 01
- Gastroenterology Department ENDOMED, s.r.o.
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-
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Celje, 슬로베니아, 3000
- Splosna bolnisnica Celje
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Ljubljana, 슬로베니아, 1000
- Univerzitetni klinicni center Ljubljana
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Buenos Aires, 아르헨티나, C1119ACN
- CIPREC
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Buenos Aires, 아르헨티나, C1280AEB
- Hospital Britanico de Buenos Aires
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Ciudad Autonoma Buenos Aires, 아르헨티나, C1264AAN
- Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo
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Córdoba, 아르헨티나, X5002AOQ
- Sanatorio Duarte Quiroz
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Mar del Plata, 아르헨티나, B7600FYK
- Centro de Investigaciones Medicas Mar Del Plata
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Rosario, 아르헨티나, 2002
- Hospital Provincial del Centenario
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-
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-
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Tallinn, 에스토니아, 10138
- East Tallinn Central Hospital
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Tallinn, 에스토니아, 10617
- West Tallinn Central Hospital
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Tartu, 에스토니아, 51014
- Tartu University Hospital
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Belfast, 영국, BT12 6BA
- Royal Victoria Hospital
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Cambridge, 영국, CB2 0QQ
- Addenbrooke's Hospital
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Glasgow, 영국, G51 4TF
- Queen Elizabeth University Hospital
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High Wycombe, 영국, HP112QW
- Velocity Clinical Research
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London, 영국, SW17 0QT
- St Georges University Hospital NHS Foundation Trust
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London, 영국, SW109NH
- Chelsea And Westminster Hospital
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Oxford, 영국, OX3 9DU
- John Radcliffe Hospital
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-
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Salzburg, 오스트리아, 5020
- Universitaetsklinikum Salzburg Landeskrankenhaus
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Vienna, 오스트리아, 1020
- Krankenhaus der Barmherzigen Brüder
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Vienna, 오스트리아, 1090
- Medizinische Universitaet Wien
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Wels, 오스트리아, 4600
- Klinikum Wels Grieskirchen
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-
-
-
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Amman, 요르단, 11942
- Jordan University Hospital
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Amman, 요르단, 11184
- Istishari Hospital
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Irbid, 요르단, 22110
- King Abdullah University Hospital
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Irbid, 요르단, 21110
- Irbid Specialty Hospital
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-
-
-
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Afula, 이스라엘, 1834111
- Haemek Medical Center - Afula
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Haifa, 이스라엘, 31096
- Rambam Medical Center
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Haifa, 이스라엘, 3339419
- Bnai Zion Medical Center
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Jerusalem, 이스라엘, 9103102
- Shaare Zedek Medical Center
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Jerusalem, 이스라엘, 91120
- Hadassah Hebrew University Medical Center
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Petah Tikva, 이스라엘, 49100
- Rabin Medical Center Beilinson Campus
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Rehovot, 이스라엘, 76100
- Kaplan Medical Center
-
Tel Aviv, 이스라엘, 6423906
- Tel Aviv Sourasky Medical Center
-
Tel HaShomer, 이스라엘, 52621
- The Chaim Sheba Medical Center
-
Tzrifin, 이스라엘, 70300
- Assaf Harofeh Medical Center
-
-
-
-
-
Bari, 이탈리아, 70124
- Università degli Studi di Bari
-
Catania, 이탈리아, 95126
- A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale
-
Messina, 이탈리아, 98125
- AOU Policlinico G.Martino
-
Milan, 이탈리아, 20132
- Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele
-
Monserrato, 이탈리아, 09042
- Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
-
Monza, 이탈리아, 20090
- Azienda Ospedaliera San Gerardo
-
Negrar, 이탈리아, 37024
- Ospedale Sacro Cuore Don Calabria
-
Palermo, 이탈리아, 90146
- Ospedale Villa Sofia-Cervello
-
Roma, 이탈리아, 00168
- Policlinico Universitario Agostino Gemelli
-
Roma, 이탈리아, 00128
- Università Campus Biomedico di Roma
-
Rozzano, 이탈리아, 20089
- IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
-
San Giovanni Rotondo, 이탈리아, 71013
- Casa Sollievo della Sofferenza
-
-
-
-
-
Bangalore, 인도, 560054
- M S Ramaiah Medical College and Hospital
-
Bhubaneswar, 인도, 751003
- Siksha O Anusandhan University - Institute of Medical Scienc
-
Jaipur, 인도, 302017
- Apex Hospitals Ltd
-
New Delhi, 인도, 110029
- All India Institute of Medical Sciences
-
New Delhi, 인도, 110060
- Sir Ganga Ram Hospital
-
New Delhi, 인도, 110088
- Fortis Hospital
-
New Delhi, 인도, 110 002
- G.B. Pant Hospital
-
Secunderabad, 인도, 500003
- Yashoda Super Speciality Hospitals
-
Surat, 인도, 395002
- Surat Institute of Digestive Sciences Hospitals
-
-
-
-
-
Asahikawa, 일본, 078-8510
- Asahikawa Medical University Hospital
-
Bunkyō City, 일본, 113 8519
- Tokyo Medical and Dental University Hospital
-
Chikushino-shi, 일본, 818-8502
- Fukuoka University Chikushi Hospital
-
Fukuoka-ken, 일본, 802-0077
- Kitakyushu Municipal Medical Center
-
Gifu, 일본, 500-8717
- Gifu Prefectural General Medical Center
-
Hachiōji, 일본, 192-0032
- Tokai University Hachioji Hospital
-
Hamamatsu, 일본, 431-3192
- Hamamatsu University Hospital
-
Hirosaki, 일본, 036-8563
- Hirosaki University Hospital
-
Hirosaki, 일본, 036-8545
- National Hospital Organization Hirosaki General Medical Center
-
Isehara, 일본, 259-1193
- Tokai University Hospital
-
Kagoshima, 일본, 890-8520
- Kagoshima University Hospital
-
Kagoshima, 일본, 892-0843
- Kagoshima IBD Gastroenterology Clinic
-
Kamakura, 일본, 247-0056
- Ofuna Chuo Hospital
-
Kanagawa, 일본, 220-0045
- Matsushima Clinic
-
Kashihara, 일본, 634-8522
- Nara Medical University Hospital
-
Kashiwa, 일본, 277-0871
- Tsujinaka Hospital Kashiwanoha
-
Kobe, 일본, 650-0017
- Kobe University Hospital
-
Kofu, 일본, 400-0027
- Yamanashi Prefectural Central Hospital
-
Kumamoto, 일본, 860-8556
- Kumamoto University Hospital
-
Kurume, 일본, 830-0011
- Kurume University Hospital
-
Kyoto, 일본, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
-
Kyoto, 일본, 606 8507
- Kyoto University Hospital
-
Maebashi, 일본, 371-8511
- Gunma University Hospital
-
Minatoku, 일본, 108-8642
- Kitasato University Kitasato Institute Hospital
-
Mitaka, 일본, 181-8611
- Kyorin University Hospital
-
Morioka, 일본, 112-0015
- Iwate Medical University Hospital
-
Nagoya, 일본, 467-8602
- Nagoya City University Hospital
-
Nagoya, 일본, 466 8560
- Nagoya University Hospital
-
Nishinomiya, 일본, 663-8501
- The Hospital of Hyogo College of Medicine
-
Osaka, 일본, 540-0006
- National Hospital Organization Osaka National Hospital
-
Osaka, 일본, 545-8586
- Osaka City University Hospital
-
Osaka, 일본, 530-0011
- Kinshukai Infusion Clinic
-
Osaka, 일본, 553-0003
- Japan Community Health Care Organization Osaka Hospital
-
Sakura, 일본, 285-8741
- Toho University Sakura Medical Center
-
Sapporo, 일본, 065-0033
- Sapporo Higashi Tokushukai Hospital
-
Sapporo, 일본, 004-0041
- Sapporo Tokushukai Hospital
-
Sapporo, 일본, 060-0033
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
-
Sapporo Chuo-ku, 일본, 064-0919
- Sapporo IBD Clinic
-
Sumida Ku, 일본, 130 8575
- Tokyo Metropolitan Bokutoh Hospital
-
Tokyo, 일본, 160-0023
- Tokyo Medical University Hospital
-
Tokyo, 일본, 108-0073
- Tokyo Saiseikai Central Hospital
-
Tokyo, 일본, 105 8471
- The Jikei University Hospital
-
Tokyo, 일본, 152 8902
- National Hospital Organization Tokyo Medical Center
-
Tomakomai, 일본, 053-8506
- Oji General Hospital
-
Toyama, 일본, 930 8550
- Toyama Prefectural Central Hospital
-
Toyota, 일본, 470-0396
- Toyota Kosei Hospital
-
Tsu, 일본, 514-8507
- Mie University Hospital
-
Tsukuba, 일본, 305 8576
- University of Tsukuba Hospital
-
Wakayama, 일본, 641 8510
- Wakayama Medical University Hospital
-
Yokohama, 일본, 232 0024
- Yokohama City University Medical Center
-
Ōgaki, 일본, 503-8502
- Ogaki Municipal Hospital
-
Ōita, 일본, 870-0033
- Oita Red Cross Hospital
-
-
-
-
-
Chaoyang, 중국, 100013
- China Japan Friendship Hospital
-
Chengdu, 중국, 610041
- West China Hospital Sichuan University
-
Hangzhou, 중국, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
-
Jinhua, 중국, 321000
- Jinhua municipal central hospital
-
Nanjing, 중국, 210009
- Zhongda Hospital Southeast University
-
Wuhan, 중국, 430022
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology
-
-
-
-
-
Brno, 체코, 636 00
- Vojenska nemocnice Brno
-
Prague, 체코, 170 04
- ISCARE a.s.
-
-
-
-
-
Concepción, 칠레, 4030000
- Hospital Clinico Regional Dr. Guillermo Grant Benavente
-
Santiago, 칠레, 8331143
- Centro de Estudios Clínicos e Investigación Médica (CeCim)
-
Santiago, 칠레, 7640881
- Clinica Dermacross S A
-
Santiago, 칠레, 8207257
- Complejo Asistencial Hospital Dr. Sótero del Río
-
-
-
-
-
Bridgewater, 캐나다, B4V 3N2
- Viable Clinical Research
-
Saguenay, 캐나다, G7H3C3
- Hopital Chicoutimi
-
-
Alberta
-
Calgary, Alberta, 캐나다, T2N 2T9
- Foothills Hospital
-
Edmonton, Alberta, 캐나다, T5R 1W2
- Gastroenterology and Internal Medicine Research Institute (GIRI)
-
Edmonton, Alberta, 캐나다, T6L 6K3
- Covenant Health/Grey Nuns hospital
-
-
British Columbia
-
New Westminster, British Columbia, 캐나다
- Columbia Gastroenterology
-
Vancouver, British Columbia, 캐나다, V5Z 1M9
- The Gordon & Leslie Diamond Health Care Center
-
Vancouver, British Columbia, 캐나다, V6Z 2K5
- GIRI Gastrointestinal Research Institute
-
Vancouver, British Columbia, 캐나다, V7M 2H4
- The Medical Arts Health Research Group
-
Victoria, British Columbia, 캐나다, V8P 2P5
- PerCuro Clinical Research Ltd.
-
-
Manitoba
-
Winnipeg, Manitoba, 캐나다, R3A 1R9
- Health Sciences Centre
-
-
Nova Scotia
-
Dartmouth, Nova Scotia, 캐나다, B2W 6L4
- Viable Clinical Research 1
-
Halifax, Nova Scotia, 캐나다, B3H 1V7
- Nova Scotia Health Authority
-
-
Ontario
-
London, Ontario, 캐나다, N6A 5A5
- London Health Sciences Centre - University Campus
-
Toronto, Ontario, 캐나다, M6A 3B4
- Toronto Immune and Digestive Health Institute Inc
-
-
Quebec
-
Montreal, Quebec, 캐나다, H1T 2M4
- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
-
Montreal, Quebec, 캐나다, H3G 1A4
- McGill University - Health Centre - Montreal General Hospital
-
Mount Royal, Quebec, 캐나다, H3P 3E5
- CMIIM, Centre médical L'Enjeu
-
Saint-Jérôme, Quebec, 캐나다, V8R 4R2
- St. Jerome Medical Research
-
-
-
-
-
Bjelovar, 크로아티아, 43000
- Opca bolnica Bjelovar
-
Split, 크로아티아, 21000
- University Hospital Center Split
-
Zagreb, 크로아티아, 10000
- University Hospital Dubrava
-
-
-
-
-
Lisbon, 포르투갈, 1649-035
- Centro Hospitalar de Lisboa Norte Hospital Santa Maria
-
Loures, 포르투갈, 2674 514
- Uls Loures Odivelas - Hosp. Loures
-
Portimão, 포르투갈, 8500-338
- Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
-
Santa Maria da Feira, 포르투갈, 4520-211
- Centro Hospitalar de Entre o Douro e Vouga, E.P.E
-
Vila Nova de Gaia, 포르투갈, 4434 502
- Uls Gaia Espinho
-
-
-
-
-
Bydgoszcz, 폴란드, 85-168
- Szpital Uniwersytecki No2
-
Krakow, 폴란드, 30 363
- Centrum Medyczne Plejady
-
Krakow, 폴란드, 31-513
- Centrum Medyczne Promed
-
Lodz, 폴란드, 90-644
- AmiCare Centrum Medyczne
-
Lublin, 폴란드, 20-412
- ETG Lublin
-
Lublin, 폴란드, 20-582
- Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.
-
Nowy Targ, 폴란드, 34 400
- Allmedica
-
Olsztyn, 폴란드, 10 561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
-
Poznan, 폴란드, 61-293
- Twoja Przychodnia
-
Poznan, 폴란드, 61 441
- Synexus Polska Sp z o o
-
Rzeszów, 폴란드, 35-326
- Centrum Medyczne Medyk
-
Sopot, 폴란드, 81-756
- Endoskopia Sp z o.o.
-
Szczecin, 폴란드, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
-
Szczecin, 폴란드, 71-685
- Sonomed Sp. z o.o.
-
Torun, 폴란드, 87 100
- GASTROMED Sp. z o.o.
-
Warsaw, 폴란드, 00 632
- Centrum Zdrowia Matki Dziecka i Mlodziezy
-
Warsaw, 폴란드, 03 580
- NZOZ Vivamed
-
Warsaw, 폴란드, 03 712
- Bodyclinic Sp. z o.o. sp. k
-
Warsaw, 폴란드, 02-655
- Reumatika-Centrum Reumatologii, NZOZ
-
Warsaw, 폴란드, 02 507
- Centralny Szpital Kliniczny Mswia
-
Wroclaw, 폴란드, 54 144
- EuroMediCare Szpital Specjalistyczny z Przychodnia
-
Wroclaw, 폴란드, 50 449
- Melita Medical Sp. z o.o.
-
Wroclaw, 폴란드, 53 149
- Przychodnia Vistamed
-
Wroclaw, 폴란드, 52 415
- Centrum Medyczne Oporow
-
Włocławek, 폴란드, 87-800
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
-
Zamość, 폴란드, 22-400
- ETG Zamosc
-
-
-
-
-
Amiens, 프랑스, 80054
- CHU Amiens - Hopital Sud
-
Colombes, 프랑스, 92701
- Hopital Louis Mourier
-
Créteil, 프랑스, 94010
- Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
-
Grenoble, 프랑스, 38700
- CHU Grenoble
-
La Roche-sur-Yon, 프랑스, 85925
- Centre Hospitalier Départemental VENDEE
-
Lille, 프랑스, 59037
- CHRU de Lille Hopital Claude Huriez
-
Marseille, 프랑스, 13915
- Hopital Nord Marseille
-
Montpellier, 프랑스, 34295
- Hopital Saint Eloi
-
Neuilly-sur-Seine, 프랑스, 92200
- Clinique Ambroise Pare
-
Nice, 프랑스, 06202
- CHU de Nice Hopital de l Archet
-
Nîmes, 프랑스, 30029
- CHU Nimes Hopital Caremeau
-
Pessac, 프랑스, 33604
- Hopital Haut-Leveque, CMC Magellan
-
Pierre-Bénite, 프랑스, 69495
- Hospices Civils de Lyon HCL
-
Saint-Etienne, 프랑스, 42270
- CHU Saint Etienne
-
Toulouse, 프랑스, 31059
- Hopital de Rangueil
-
Vandœuvre-lès-Nancy, 프랑스, 54511
- CHRU Nancy Brabois
-
-
-
-
-
Budapest, 헝가리, 1036
- Obudai Egeszsegugyi Centrum Kft
-
Budapest, 헝가리, 1062
- Magyar Honvedseg Egeszsegugyi Kozpont
-
Budapest, 헝가리, H-1088
- Semmelweis Egyetem
-
Budapest, 헝가리, H-1136
- Pannónia Magánorvosi Centrum Kft
-
Gyöngyös, 헝가리, 3200
- Bugat Pal Korhaz
-
Szeged, 헝가리, 6720
- Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp
-
Szombathely, 헝가리, H-9700
- Markusovszky Egyetemi Oktatokorhaz
-
-
-
-
-
Box Hill, 호주, 3128
- Box Hill Hospital
-
Camperdown, 호주, 2050
- Royal Prince Alfred Hospital
-
Clayton, 호주, 3168
- Monash Health, Monash Medical Centre
-
Concord, 호주, 2139
- Concord Hospital
-
Footscray, 호주, 3011
- Western Health
-
Maroochydore, 호주, 4558
- Coastal Digestive Health
-
Murdoch, 호주, 6150
- Fiona Stanley Hospital
-
North Terrace, 호주, 5000
- Royal Adelaide Hospital
-
Parkville, 호주, 3050
- Royal Melbourne Hospital
-
Prahran, 호주, 3004
- The Alfred Hospital
-
South Brisbane, 호주, 4101
- Mater Hospital Brisbane
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
- Moderately to severely active UC as assessed by the modified Mayo score
- Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
- If female and of childbearing potential, must meet the contraception and reproduction requirements
Exclusion Criteria:
- Has severe extensive colitis as defined in the protocol
- Extent of inflammatory disease limited to the rectum
- Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
- Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
- Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: Group 1: Placebo
Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
Placebo will be administered as subcutaneous injection. |
|
실험적: Group 2: Guselkumab
Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
Guselkumab will be administered as subcutaneous injection. |
|
실험적: Group 3: Golimumab
Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
Golimumab will be administered as subcutaneous injection. |
|
실험적: Group 4: JNJ-78934804 (High-dose)
Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
JNJ-78934804 will be administered subcutaneously as per defined regimen. |
|
실험적: Group 5: JNJ-78934804 (Mid-dose)
Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
JNJ-78934804 will be administered subcutaneously as per defined regimen. |
|
실험적: Group 6: JNJ-78934804 (Low-dose)
Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
JNJ-78934804 will be administered subcutaneously as per defined regimen. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants with Clinical Remission at Week 48
기간: Week 48
|
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores. |
Week 48
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants with Adverse Events (AEs)
기간: Up to Week 48
|
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. |
Up to Week 48
|
|
Percentage of Participants with Serious Adverse Events (SAEs)
기간: Up to Week 48
|
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important. |
Up to Week 48
|
|
Serum Concentrations of Guselkumab Over Time
기간: Up to Week 48
|
Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method. |
Up to Week 48
|
|
Percentage of Participants with Antibodies to Guselkumab
기간: Up to Week 48
|
Percentage of participants with antibodies to guselkumab will be reported. |
Up to Week 48
|
|
Titers of Antibodies to Guselkumab
기간: Up to Week 48
|
Titers of antibodies to guselkumab will be reported. |
Up to Week 48
|
|
Titers of Antibodies to Golimumab
기간: Up to Week 48
|
Titers of antibodies to golimumab will be reported. |
Up to Week 48
|
|
Percentage of Participants with Neutralizing Antibodies to Golimumab
기간: Up to Week 48
|
Percentage of participants with neutralizing antibodies to golimumab will be reported. |
Up to Week 48
|
|
Percentage of Participants with Endoscopic Improvement at Week 48
기간: Week 48
|
Percentage of participants with endoscopic improvement at Week 48 will be reported. Endoscopic improvement at Week 48 based on the Mayo endoscopic subscore. |
Week 48
|
|
Percentage of Participants with Corticosteroid-free Clinical Remission at Week 48
기간: Week 48
|
Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported. |
Week 48
|
|
Percentage of Participants with Symptomatic Remission at Week 48
기간: Week 48
|
Percentage of participants with symptomatic remission at Week 48 will be reported. Symptomatic remission at Week 48 based on stool and rectal bleeding symptoms. |
Week 48
|
|
Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48
기간: Week 48
|
Percentage of participants with combination of histological remission and endoscopic improvement at Week 48 will be reported. Histologic remission and endoscopic improvement at Week 48 based on the histologic grading and the Mayo endoscopy subscore. |
Week 48
|
|
Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48
기간: Week 48
|
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores will be reported. |
Week 48
|
|
Laboratory Parameters Over Time
기간: Up to Week 48
|
Laboratory parameters over time will be reported. |
Up to Week 48
|
|
Vital Signs Parameters Over Time
기간: Up to Week 48
|
Vital signs parameters over time will be reported. |
Up to Week 48
|
|
Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score
기간: Up to Week 48
|
The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline. |
Up to Week 48
|
|
Serum Concentrations of Golimumab Over Time
기간: Up to Week 48
|
Serum concentration of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method. |
Up to Week 48
|
|
Percentage of Participants with Antibodies to Golimumab
기간: Up to Week 48
|
Percentage of Participants with Antibodies to golimumab will be reported. |
Up to Week 48
|
|
Percentage of Participants with Neutralizing Antibodies to Guselkumab
기간: Up to Week 48
|
Percentage of participants with neutralizing antibodies to guselkumab will be reported. |
Up to Week 48
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 9월 19일
기본 완료 (실제)
2025년 5월 15일
연구 완료 (추정된)
2029년 3월 27일
연구 등록 날짜
최초 제출
2022년 2월 15일
QC 기준을 충족하는 최초 제출
2022년 2월 15일
처음 게시됨 (실제)
2022년 2월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 11월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 11월 2일
마지막으로 확인됨
2026년 11월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CR109179
- 78934804UCO2001 (기타 식별자: Janssen Research & Development, LLC)
- 2021-005528-39 (EudraCT 번호)
- 2023-504743-13-00 (레지스트리 식별자: EUCT number)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .