중등도에서 중증의 활동성 크론병 환자를 대상으로 한 구셀쿠맙 피하 요법 연구 (GRAVITI)
중등도에서 중증 활동성 크론병 환자를 대상으로 Guselkumab 피하 유도 요법의 효능과 안전성을 평가하기 위한 무작위, 이중 맹검, 위약 대조, 병렬 그룹, 다기관 연구
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드, 1091 AC
- Onze Lieve Vrouwe Gasthuis
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Rotterdam, 네덜란드, 3045 PM
- Sint Franciscus Gasthuis
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Tilburg, 네덜란드, 5022 GC
- Elisabeth-TweeSteden Ziekenhuis
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Christchurch, 뉴질랜드, 8011
- Christchurch Hospital
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Dunedin, 뉴질랜드, 9016
- Dunedin Hospital
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Kaoshiung, 대만, 80756
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Taichung, 대만, 40447
- China Medical University Hospital
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Taipei, 대만, 100
- National Taiwan University Hospital, Division of Infectious Diseases
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Taipei, 대만, 110301
- Taipei Medical University
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Taoyuan, 대만, 33305
- Linkou Chang Gung Memorial Hospital
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Busan, 대한민국, 41404
- Kyungpook National University Chilgok Hospital
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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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Busan, 대한민국, 602739
- DongA Medical Center
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Daegu, 대한민국, 42415
- Yeungnam University Medical Center
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Daejeon, 대한민국, 34943
- The Catholic University of Korea Seoul St.Mary's Hospital
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Dongdaemun-gu, 대한민국, 02447
- Kyung Hee University Hospital
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Goyang-si, 대한민국, 10326
- Dongguk University Ilsan Hospital
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Gwangju, 대한민국, 61469
- Chonnam National University Hospital
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Gyeonggi-do, 대한민국, 13496
- CHA Bundang Medical Center, CHA University
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Gyeonggi-do, 대한민국, 16247
- The Catholic university of Korea, St. Vincent's Hospital
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Seoul, 대한민국, 06351
- Samsung Medical Center
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Seoul, 대한민국, 03181
- Kangbuk Samsung Hospital
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Seoul, 대한민국, 03722
- Yonsei University College of Medicine
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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
- Wonju Christian Hospital
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Yangch’ŏn-gu, 대한민국, 07985
- Ewha Womans University Mokdong Hospital
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Esbjerg, 덴마크, 6700
- Sydvestjysk Sygehus
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Hilleroed, 덴마크, 3400
- Nordsjaellands Hospital - Hillerod
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Berlin, 독일, 14050
- DRK Kliniken Westend
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Berlin, 독일, 14163
- Krankenhaus Waldfriede Mitte
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Berlin, 독일, 10117
- Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
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Berlin, 독일, 10318
- CED Studienzentrum Karlshorst
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Braunschweig, 독일, 38126
- Staedtisches Klinikum Braunschweig
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Cologne, 독일, 51103
- Evangelisches Krankenhaus Kalk
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Dachau, 독일, 85221
- Medizinisches Versorgungszentrum (MVZ) Dachau
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Duisburg, 독일, 47055
- MVZ Sanaklinikum Duisburg
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Halle, 독일, 6108
- Studiengesellschaft Mitteldeutschland GmbH
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Hanover, 독일, 30625
- Medizinische Hochschule Hannover
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Jerichow, 독일, 39319
- Praxisgemeinschaft Jerichow
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Mannheim, 독일, 68167
- Universitaetsklinikum Mannheim
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Nordhausen, 독일, 99734
- Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
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Kaunas, 리투아니아, 44307
- Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
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Vilnius, 리투아니아, LT-08661
- Vilnius University Hospital Santaros Klinikos, Public Institution
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Johor Bharu, 말레이시아, 80100
- Hospital Sultanah Aminah
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Kota Bharu, 말레이시아, 16150
- Hospital University Sains Malaysia
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Kota Kinabalu, 말레이시아, 88586
- Hospital Raja Permaisuri Bainun
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Kuala Lumpur, 말레이시아, 59100
- University Malaya Medical Centre
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Kuantan, 말레이시아, 25100
- Hospital Tengku Ampuan Afzan
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Alabama
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Dothan, Alabama, 미국, 36305
- Digestive Health Specialists of the Southeast
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Arizona
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Chandler, Arizona, 미국, 85224-1636
- Advanced Gastro P.C
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Scottsdale, Arizona, 미국, 85260
- Reliance Research
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Arkansas
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Little Rock, Arkansas, 미국, 72205-6414
- Moore Clinical Trials, LLC
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Little Rock, Arkansas, 미국, 72223
- Central Arkansas Veterans Healthcare System
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California
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Anaheim, California, 미국, 92805
- Clinnova Research
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Lancaster, California, 미국, 93534
- Om Research LLC
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Lancaster, California, 미국, 93534
- Om Research LLC 1
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Los Alamitos, California, 미국, 90720
- United Gastroenterologists
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Los Angeles, California, 미국, 90048
- Paul Wallace MD
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Pasadena, California, 미국, 77505-3950
- Digestive System Healthcare
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San Diego, California, 미국, 92103
- Clinical Applications Laboratories, Inc
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San Diego, California, 미국, 92103-2120
- Northshore Gastroenterology Research, LLC
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Santa Maria, California, 미국, 93454
- Santa Maria Gastroenterology
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Walnut Creek, California, 미국, 94598
- Clinical Research of California
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Colorado
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Grand Junction, Colorado, 미국, 81505-1027
- Amel Med LLC Research
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Connecticut
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Danbury, Connecticut, 미국, 06810
- Western Connecticut Health Network/Danbury Hospital
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Florida
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Clearwater, Florida, 미국, 33762-5323
- Gastroenterology Associates of SW Florida
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Coconut Creek, Florida, 미국, 33066
- Pioneer Research Solutions Inc.
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DeBary, Florida, 미국, 32713
- Omega Research Consultants
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Hialeah, Florida, 미국, 33016
- Harmony Medical Research Institute, Inc.
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Kissimmee, Florida, 미국, 34741
- Central Florida Gastro Research
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Miami, Florida, 미국, 33155
- Community Research Foundation, Inc.
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Naples, Florida, 미국, 34102
- Gastroenterology Group Of Naples
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Orlando, Florida, 미국, 32803-1853
- Center for Digestive Health
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Orlando, Florida, 미국, 32819
- Central Florida Internists
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St. Petersburg, Florida, 미국, 33705
- Synergy Clinical Research
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Georgia
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Atlanta, Georgia, 미국, 30328
- Agile Clinical Research Trials, LLC
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Atlanta, Georgia, 미국, 30224
- Atlanta Gastroenterology Specialists, PC
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Decatur, Georgia, 미국, 30033
- Atlanta Center For Gastroenterology
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Macon, Georgia, 미국, 31201
- Gastroenterolgy Associates of Central GA
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Roswell, Georgia, 미국, 30076-4943
- Gastroenterology Consultants
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Idaho
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Boise, Idaho, 미국, 83706
- USF Asthma, Allergy, Immunology Clinical Research Unit
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Idaho Falls, Idaho, 미국, 83404
- Grand Teton Research Group, PLLC
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Illinois
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Oakbrook Terrace, Illinois, 미국, 60618
- Lemah Creek Clinical Research
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Kansas
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Kansas City, Kansas, 미국, 66103-2937
- University of Kansas Medical Center
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Leawood, Kansas, 미국, 66211
- BVL Clinical Research
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Topeka, Kansas, 미국, 66606
- Cotton O'Neil Digestive Health Center
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Kentucky
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Crestview Hills, Kentucky, 미국, 41017
- Tri-State Gastroenterology Assoc
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Louisiana
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Marrero, Louisiana, 미국, 70072
- Tandem Clinical Research
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Maryland
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Baltimore, Maryland, 미국, 21202-2102
- Institute for Digestive Health and Liver Disease
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Glen Burnie, Maryland, 미국, 21061
- Woodholme Gastroenterology Associates
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Massachusetts
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Chelmsford, Massachusetts, 미국, 01824
- Digestive Health Specialists PC
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South Dartmouth, Massachusetts, 미국, 02747
- FC Research, LLC
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Michigan
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Chesterfield, Michigan, 미국, 48047
- Clinical Research Institute of Michigan, LLC
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Livonia, Michigan, 미국, 48152
- Detroit Clinical Research Center
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Mississippi
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Jackson, Mississippi, 미국, 39216
- University of Mississippi Medical Center
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New York
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Brooklyn, New York, 미국, 11203
- SUNY Downstate Medical Center
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Jackson Heights, New York, 미국, 11372
- Smart Medical Research
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Middletown, New York, 미국, 10941
- Crystal Run Healthcare LLP
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New York, New York, 미국, 10075
- New York Gastroenterology Associates
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North Massapequa, New York, 미국, 11758
- DiGiovanna Institute for Medical Education & Research
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Queens, New York, 미국, 11375
- A1 Clinical Network
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North Carolina
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Charlotte, North Carolina, 미국, 28207
- Carolinas Medical Center
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Charlotte, North Carolina, 미국, 28277
- Onsite Clinical Solutions
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Greenville, North Carolina, 미국, 27834
- Carolina Research
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Winston-Salem, North Carolina, 미국, 27103
- Gastroenterology Associates of the Piedmont, P.A.
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Ohio
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Columbus, Ohio, 미국, 43214
- Central Ohio Endoscopy Center LLC
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Dayton, Ohio, 미국, 45440
- Dayton Gastroenterology, Inc
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Mentor, Ohio, 미국, 44060
- Great Lakes Gastroenterology
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- Oklahoma University Health Science Center
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Oklahoma City, Oklahoma, 미국, 73112
- Integris Baptist Office
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Oklahoma City, Oklahoma, 미국, 73120
- Central Sooner Research
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Tulsa, Oklahoma, 미국, 74137-7061
- Essential Medical Research
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Oregon
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Portland, Oregon, 미국, 97220-9428
- The Oregon Clinic
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Pennsylvania
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Smithfield, Pennsylvania, 미국, 15478
- Frontier Clinical Research
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South Carolina
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Greenville, South Carolina, 미국, 29615
- Gastroenterology Associates P.A.
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Myrtle Beach, South Carolina, 미국, 29572
- Carolina Health Specialists
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Texas
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Lubbock, Texas, 미국, 79424
- West Texas Clinical Research
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Richmond, Texas, 미국, 77407
- Victoria Gastroenterology
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San Antonio, Texas, 미국, 78229
- Gastroenterology Clinic Of San Antonio P A
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San Antonio, Texas, 미국, 78232
- Wellness Clinical Research
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Southlake, Texas, 미국, 76092
- Texas Digestive Disease Consultants
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Tyler, Texas, 미국, 75701
- Digestive Health Specialists of Tyler
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Utah
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Salt Lake City, Utah, 미국, 84124
- Care Access Research- Salt Lake City
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Virginia
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Burke, Virginia, 미국, 22015
- Burke Internal Medicine and Research
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Chesapeake, Virginia, 미국, 23320
- Gastroenterology Associates of Tidewater
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Aalst, 벨기에, 9300
- OLV Ziekenhuis Aalst
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Brussels, 벨기에, 1070
- Hopital Erasme
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Brussels, 벨기에, 1000
- CHU Saint-Pierre
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Ghent, 벨기에, 9000
- Universitair Ziekenhuis Gent
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Roeselare, 벨기에, 8800
- Algemeen Ziekenhuis Delta
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Banja Luka, 보스니아 헤르체고비나, 78000
- University hospital Clinical centre Banja Luka
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Sarajevo, 보스니아 헤르체고비나, 71000
- Clinical Center University of Sarajevo
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Sarajevo, 보스니아 헤르체고비나, 71000
- Polyclinic Dr. Al-Tawil
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Tešanj, 보스니아 헤르체고비나, 74260
- General Hospital Tesanj
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Tuzla, 보스니아 헤르체고비나, 75000
- Plava poliklinika Tuzla
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Zenica, 보스니아 헤르체고비나, 72000
- Cantonal Hospital Zenica
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Botucatu, 브라질, 18608-025
- Universidade Estadual Paulista 'Julio De Mesquita Filho'
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Brasília, 브라질, 70200-730
- CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
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Brasília, 브라질, 72145 450
- Chronos Clinica Medica Ltda
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Campinas, 브라질, 13060-904
- Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
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Curitiba, 브라질, 80430-180
- CDC - Centro Digestivo de Curitiba
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Fortaleza, 브라질, 60430-370
- Universidade Federal Do Ceara
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Jaú, 브라질, 17201-130
- Centro de Estudos Clínicos do Interior Paulista - CECIP
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Macaé, 브라질, 27910-020
- Cliged
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Natal, 브라질, 59062 000
- Liga Norte Riograndense Contra O Cancer
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Passo Fundo, 브라질, 99010-120
- Instituto Mederi de Pesquisa e Saude
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Porto Alegre, 브라질, 90035-003
- 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, 90160-092
- Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
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Porto Alegre, 브라질, 90430-001
- NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Recife, 브라질, 51011040
- Hospital das Clinicas - Universidade Federal de Pernambuco
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Salvador, 브라질, 40110-060
- Universidade Federal da Bahia - Hospital Professor Edgard Santos
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Salvador, 브라질, 40150150
- 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 Bernardo do Campo, 브라질, 09715-090
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
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São José do Rio Preto, 브라질, 15015-110
- Kaiser Hospta
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São José do Rio Preto, 브라질, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
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São Paulo, 브라질, 04543-000
- Instituto D Or de Pesquisa e Ensino IDOR
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São Paulo, 브라질, 03325-050
- BR TRIALS Ensaios Clinicos e Consultoria Ltda
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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, 04543-011
- Hepatogastro
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Teresina, 브라질, 64049-550
- Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
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Votuporanga, 브라질, 15501 405
- Integral Centro de Pesquisas Clinicas
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-
-
-
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Gijón, 스페인, 33394
- Hosp. de Cabuenes
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Huelva, 스페인, 21005
- Hosp. Gral. Juan Ramon Jimenez
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Huelva, 스페인, 21002
- Hosp. Gral. Juan Ramon Jimenez 1
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Madrid, 스페인, 28031
- Hosp. Univ. Infanta Leonor
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Seville, 스페인, 41009
- Hosp. Virgen Macarena
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Vigo, 스페인, 36213
- Hosp. Alvaro Cunqueiro
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Villajoyosa, 스페인, 03570
- Hosp. de La Marina Baixa
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-
-
-
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Banská Bystrica, 슬로바키아, 974 01
- FNsP F.D.R. Banska Bystrica
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Košice, 슬로바키아, 040 13
- ENDOMED s.r.o
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Prešov, 슬로바키아, 080 01
- GASTRO I. s.r.o.
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-
-
-
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Amman, 요르단, 11183
- Khalidi Hospital and Medical Center
-
Amman, 요르단, 11194
- The Speciality Hospital (TSH) / Advanced Clinical Center
-
Amman, 요르단, 11196
- Istiklal Hospital
-
Amman, 요르단, 1184
- Abdali Hospital
-
Irbid, 요르단, 21110
- Irbid Specialty Hospital
-
Irbid, 요르단, 22110
- Pharmaceutical Research Center Jordan University of Science and Technology Rheumatology
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-
-
-
-
Afula, 이스라엘, 1834111
- Haemek Medical Center
-
Beersheba, 이스라엘, 84101
- Soroka University Medical Center
-
Ramat Gan, 이스라엘, 5265601
- The Chaim Sheba Medical Center
-
Rehovot, 이스라엘, 76100
- Kaplan Medical Center
-
Tzrifin, 이스라엘, 70300
- Assaf Harofeh Medical Center
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-
-
-
-
Bologna, 이탈리아, 40138
- Policlinico Sant'Orsola Malpighi
-
Milan, 이탈리아, 20132
- Istituto Clinico Humanitas Rozzano, IRCCS
-
Roma, 이탈리아, 168
- Policlinico Universitario Agostino Gemelli
-
Roma, 이탈리아, 00128
- Università Campus Biomedico di Roma
-
-
-
-
-
Bunkyō City, 일본, 113-8431
- Juntendo University Hospital
-
Chūōku, 일본, 1040061
- Ginza central clinic
-
Fukui-ken, 일본, 910-8526
- Fukui Prefectural Hospital
-
Fukuoka, 일본, 814-0180
- Fukuoka University Hospital
-
Fukuoka, 일본, 815-8555
- Japanese Red Cross Fukuoka Hospital
-
Fukuyama, 일본, 720-8520
- National Hospital Organization Fukuyama Medical Center
-
Gamagōri, 일본, 443-8501
- Gamagori City Hospital
-
Gunma, 일본, 371-0034
- Gunma University Hospital
-
Hachinohe, 일본, 031-8555
- Hachinohe City Hospital
-
Hamamatsu, 일본, 431 3192
- Hamamatsu University Hospital
-
Hamamatsu, 일본, 432-8061
- Matsuda Hospital
-
Higashi-Ibaraki, 일본, 311-3193
- National Hospital Organization Mito Medical Center
-
Hiroshima, 일본, 737-8505
- Kure Kyosai Hospital
-
Iizuka-shi, 일본, 820-8505
- National Hospital Organization Shikoku Cancer Center
-
Kagoshima, 일본, 890-8520
- Kagoshima University Hospital
-
Kagoshima, 일본, 892-0843
- Kagoshima IBD Gastroenterology Clinic
-
Kashiwa, 일본, 277-0871
- Tsujinaka Hospital Kashiwanoha
-
Kitakyushu, 일본, 800-0229
- Kyushu Rosai Hospital
-
Kobe, 일본, 650 0017
- Kobe University Hospital
-
Kofu, 일본, 400-8506
- Yamanashi Prefectural Central Hospital
-
Koshigaya, 일본, 343-8555
- Dokkyo Medical University Saitama Medical Center
-
Kurume, 일본, 839-0809
- Hidaka Coloproctologic Clinic
-
Kyoto, 일본, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
-
Kyoto, 일본, 602-8026
- Japanese Red Cross Kyoto Daini Hospital
-
Morioka, 일본, 020-8505
- Iwate Medical University Hospital
-
Nagasaki, 일본, 852-8501
- Nagasaki University Hospital
-
Nagoya, 일본, 460-0022
- Yokoyama IBD Clinic
-
Nakagami-gun, 일본, 901-2132
- University of the Ryukyus Hospital
-
Niigata, 일본, 951 8520
- Niigata University Medical And Dental Hospital
-
Nishinomiya, 일본, 663-8014
- Nishinomiya Municipal Central Hospital
-
Osaka, 일본, 540-0006
- National Hospital Organization Osaka National Hospital
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Osaka, 일본, 558-8558
- Osaka General Medical Center
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Osaka, 일본, 543-8555
- Japanese Red Cross Osaka Hospital
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Osaka, 일본, 530-0011
- Kinshukai Infusion Clinic
-
Sapporo, 일본, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Sendai, 일본, 981-3213
- Takagi Clinic
-
Sunto-gun, 일본, 411-8611
- National Hospital Organization Shizuoka Medical Center
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Tokyo, 일본, 160-0023
- Tokyo Medical University Hospital
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Toyota, 일본, 470-0396
- Toyota Kosei Hospital
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Yokohama, 일본, 232 0024
- Yokohama City University Medical Center
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Ōita, 일본, 870-0033
- Oita Red Cross Hospital
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Ōtsu, 일본, 520-2192
- Shiga University of Medical Science Hospital
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-
-
-
-
Bengbu, 중국, 233004
- The Affiliated Hospital of Bengbu Medical College
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Changsha, 중국, 410008
- Xiangya Hospital Central South University
-
Changsha, 중국, 410011
- The second Xiangya Hospital of Central South University
-
Changzhou, 중국, 213004
- Changzhou No 2 Peoples Hospital
-
Chengdu, 중국, 610041
- West China Hospital Sichuan University
-
Chongqing, 중국, 400013
- Chongqing Medical University
-
Foshan, 중국, 528010
- The First People's Hospital of Foshan
-
Fuzhou, 중국, 350005
- The First Affiliated Hospital of Fujian Medical University
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Ganzhou, 중국, 341000
- First Affiliated Hospital of Gannan Medical University
-
Guangzhou, 중국, 510180
- Guangzhou First Municipal People's Hospital
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Guangzhou, 중국, 510080
- Guangdong Provincial People's Hospital
-
Guangzhou, 중국, 510260
- Guangzhou Medical University
-
Hangzhou, 중국, 310006
- Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
-
Hangzhou, 중국, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Hefei, 중국, 230022
- The First Affiliated Hospital of Anhui Medical University
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Nanchang, 중국, 330006
- The First Affiliated Hospital of NanChang University
-
Nanjing, 중국, 210008
- Nanjing Drum Tower Hospital
-
Nanjing, 중국, 210006
- Nanjing 1st Hospital
-
Quanzhou, 중국, 362002
- The First Hospital of Quanzhou
-
Shanghai, 중국, 200040
- Huashan Hospital Fudan University
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Shanghai, 중국, 200120
- Shanghai East Hospital
-
Shenyang, 중국, 110022
- Shengjing Hospital Of China Medical University
-
Suzhou, 중국
- The first affiliated hospital of suzhou University
-
Wuxi, 중국, 214023
- Wuxi People s Hospital
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Yangzhou, 중국, 225001
- Yangzhou First People's Hospital
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Zhuzhou, 중국, 412007
- ZhuZhou Central Hospital
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-
-
-
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Brno, 체코, 636 00
- Fakultni nemocnice Brno
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Hradec Králové, 체코, 500 05
- Fakultni nemocnice Hradec Kralove
-
Kladno, 체코, 27259
- Oblastni nemocnice Kladno a.s.
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Prague, 체코, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Slaný, 체코, 274 01
- Nemocnice Slany
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-
-
-
Ontario
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London, Ontario, 캐나다, N6A 5A5
- London Health Sciences Centre
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North Bay, Ontario, 캐나다, P1B 2H3
- North Bay Dermatology Centre
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-
-
-
-
Bjelovar, 크로아티아, 43000
- Opca bolnica Bjelovar
-
Split, 크로아티아, 21000
- University Hospital Center Split
-
Zadar, 크로아티아, 23000
- Opca bolnica Zadar
-
Zagreb, 크로아티아, 10000
- Poliklinika Solmed
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-
-
-
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Ankara, 터키 (Türkiye), 06100
- Ankara Numune Egitim ve Arastirma Hastanesi
-
Ankara, 터키 (Türkiye), 06230
- Hacettepe University Hospital
-
Ankara, 터키 (Türkiye), 06560
- Gazi University Medical Faculty
-
Istanbul, 터키 (Türkiye), 34349
- Acibadem Fulya Hospital
-
Izmir, 터키 (Türkiye), 35040
- Ege Universitesi Tip Fakultesi
-
Mersin, 터키 (Türkiye), 33343
- Mersin University Medical Faculty
-
Samsun, 터키 (Türkiye), 55420
- Ondokuz Mayis University
-
Zonguldak, 터키 (Türkiye), 67000
- Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
-
-
-
-
-
Bialystok, 폴란드, 15-322
- Gastromed Kralisz Romatowski Stachurska Sp. j.
-
Bydgoszcz, 폴란드, 85 231
- NZOZ Centrum Medyczne KERmed
-
Chojnice, 폴란드, 89-600
- Centrum Medyczne Lukamed
-
Chojnice, 폴란드, 89 600
- Centrum Medyczne Lukamed Sp z o o
-
Chrzanów, 폴란드, 32-500
- Sahlgrenska University Hospital
-
Knurów, 폴란드, 44 190
- MZ Badania Slowik Zymla Spolka jawna
-
Krakow, 폴란드, 30 149
- Malopolskie Centrum Kliniczne
-
Krakow, 폴란드, 30 363
- Centrum Medyczne Plejady
-
Krakow, 폴란드, 31 637
- Centrum Medyczne ProMiMed
-
Lodz, 폴란드, 90-752
- IP Clinic Sp. z o.o.
-
Lodz, 폴란드, 91 034
- Centrum Medyczne Med Gastr
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Lodz, 폴란드, 90-644
- AmiCare Centrum Medyczne
-
Lublin, 폴란드, 20-412
- ETG Lublin
-
Lublin, 폴란드, 20 582
- REUMED Zespol Poradni Specjalistycznych Filia nr 2
-
Nowy Targ, 폴란드, 34 400
- Allmedica
-
Olsztyn, 폴란드, 10 561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
-
Opole, 폴란드, 45-819
- Twoja Przychodnia 1
-
Piotrkow Trybunalski, 폴란드, 97 300
- Centrum Medyczne
-
Poznan, 폴란드, 60 309
- EMC Instytut Medyczny SA PL CERTUS
-
Poznan, 폴란드, 61 441
- Synexus Polska Sp z o o
-
Poznan, 폴란드, 61 324
- Twoja Przychodnia
-
Rzeszów, 폴란드, 35-326
- Centrum Medyczne Medyk
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Skorzewo, 폴란드, 60-185
- Centrum Medyczne Promed
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Sopot, 폴란드, 81-756
- Endoskopia Sp z o.o.
-
Sosnowiec, 폴란드, 41-200
- Kiepury Clinic
-
Straszów, 폴란드, 28 200
- KO Med Centrum Medyczne
-
Szczecin, 폴란드, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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Szczecin, 폴란드, 71-685
- Sonomed Sp. z o.o.
-
Torun, 폴란드, 87 100
- GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
-
Tychy, 폴란드, 43-100
- H-T Centrum Medyczne Endoterapia
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Warsaw, 폴란드, 02-507
- Centralny Szpital Kliniczny MSWiA w Warszawie
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Warsaw, 폴란드, 02 653
- Endoterapia
-
Warsaw, 폴란드, 00 632
- Centrum Zdrowia Matki Dziecka i Mlodziezy
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Warsaw, 폴란드, 02 798
- Medical Concierge Centrum Medyczne
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Warsaw, 폴란드, 03 580
- NZOZ Vivamed
-
Warsaw, 폴란드, 03-712
- Gabinety Lekarskie Bodyclinic
-
Warsaw, 폴란드, 04-501
- IBD Point Profesor Kierkus
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Wierzchosławice, 폴란드, 33-122
- Centrum Zdrowia Tuchow
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Wroclaw, 폴란드, 50-556
- Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
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Wroclaw, 폴란드, 53 149
- Przychodnia Vistamed
-
Wroclaw, 폴란드, 53 611
- Centrum Medyczne Melita Medical
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Wroclaw, 폴란드, 50-449
- Centrum Medyczne Melita Medical 2
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Włocławek, 폴란드, 87-800
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
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Zamość, 폴란드, 22-400
- Pro Life Medica Sp z o o ETG Zamosc
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-
-
-
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Bayonne, 프랑스, 64100
- Centre Hospitalier de la Cote Basque
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Besançon, 프랑스, 25000
- CHRU Besancon Hopital Jean Minjoz
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Colombes, 프랑스, 92701
- Hopital Louis Mourier
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Nantes, 프랑스, 44093
- CHU de Nantes hotel Dieu
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Nice, 프랑스, 06202
- CHU de Nice Hopital de l Archet
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Paris, 프랑스, 75877
- Hôpital Bichat
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Pierre-Bénite, 프랑스, 69495
- Hospices Civils de Lyon HCL
-
Reims, 프랑스, 51092
- Hôpital Robert Debré
-
Saint-Priest-en-Jarez, 프랑스, 42270
- CHU Saint Etienne Hopital Nord
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Strasbourg, 프랑스, 67098
- CHRU Strasbourg
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Toulouse, 프랑스, 31059
- CHU Rangueil
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-
-
-
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Budapest, 헝가리, 1036
- Obudai Egeszsegugyi Centrum Kft
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Budapest, 헝가리, H-1088
- Semmelweis Egyetem
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Budapest, 헝가리, H-1136
- Pannónia Magánorvosi Centrum Kft
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Budapest, 헝가리, 1097
- Egyesített Szent István és Szent László Kórház
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Budapest, 헝가리, 1126
- Mh Egészségügyi Központ
-
Budapest, 헝가리, 1125
- Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
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Kistarcsa, 헝가리, 2143
- Pest Megyei Flor Ferenc Korhaz
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Mohács, 헝가리, 7700
- Mohacsi Korhaz
-
Pécs, 헝가리, 7624
- Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
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Szombathely, 헝가리, H-9700
- Markusovszky Egyetemi Oktatokorhaz
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-
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-
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Clayton, 호주, 3168
- Monash Health, Monash Medical Centre
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North Mackay, 호주, 4740
- Coral Sea Clinical Research Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
실험적: 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. |
|
위약 비교기: Group 3: Placebo
Participants will receive placebo injection subcutaneously. |
Placebo will be administered by SC injection. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission at Week 12
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission at Week 24
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CR109125
- 2020-006165-11 (EudraCT 번호)
- CNTO1959CRD3004 (기타 식별자: Janssen Research & Development, LLC)
- 2023-504737-41-00 (레지스트리 식별자: EUCT number)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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
미국 FDA 규제 기기 제품 연구
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. .