Fistulizing, 항문 주위 크론 병을 가진 참가자에서 Guselkumab의 연구 (FUZION CD)
치루형성 항문주위 크론병 환자에서 구셀쿠맙의 효능 및 안전성을 평가하기 위한 3상, 무작위, 위약 대조, 병렬 그룹, 다기관 연구
The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
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Athens, 그리스, 10676
- Evangelismos General Hospital of Athens
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Athens, 그리스, 156 69
- Sotiria General State Hospital of Chest Diseases
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Athens, 그리스, 11528
- Hippokration Hospital 1
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Athens Attica, 그리스, 115 28
- Alexandra General Hospital of Athens
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Heraklion, 그리스, 71110
- University Hospital of Heraklion
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Larissa, 그리스, 41110
- University Hospital Of Larissa
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Pátrai, 그리스, 26504
- Patras University Hospital
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Thessaloniki, 그리스, 54642
- Hippokration Hospital
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Amsterdam, 네덜란드, 1105 AZ
- Academisch Medisch Centrum Universiteit van Amsterdam
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Nijmegen, 네덜란드, 6525 GA
- Radboudumc
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Rotterdam, 네덜란드, 3015 CE
- Erasmus MC
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Utrecht, 네덜란드, 3584 CX
- UMC Utrecht
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Changhua, 대만, 500
- Changhua Christian Hospital
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Taichung, 대만, 40705
- Taichung Veterans General Hospital
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Taipei, 대만, 10002
- National Taiwan University Hospital
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Taoyuan City, 대만, 333
- Chang Gung Memorial Hospital Linkou Branch
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Busan, 대한민국, 48108
- Inje University Haeundae Paik Hospital
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Daegu, 대한민국, 42415
- Yeungnam University Hospital
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Gyeonggi-do, 대한민국, 13620
- Seoul National University Bundang Hospital
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Berlin, 독일, 10117
- Charite - Campus Mitte
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Frankfurt, 독일, 60590
- JWG-University Hospital
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Kiel, 독일, 24105
- Universitatsklinikum Schleswig Holstein Kiel
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Mannheim, 독일, 68167
- Universitaetsklinikum Mannheim
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Ulm, 독일, 89081
- Universitaetsklinikum Ulm
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
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Connecticut
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New Haven, Connecticut, 미국, 06510
- Yale University
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Florida
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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, 32804
- AdventHealth Medical Group Blood & Marrow Transplant at Orlando
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Kansas
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Kansas City, Kansas, 미국, 66160
- Kansas University Medical Center
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Kentucky
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Lexington, Kentucky, 미국, 40536
- University of Kentucky Chandler Medical Center
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Louisville, Kentucky, 미국, 40202
- University of Louisville
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Missouri
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St Louis, Missouri, 미국, 63110
- Washington University School Of Medicine
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New York
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New York, New York, 미국, 10029
- Mount Sinai School of Medicine
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73112
- Digestive Disease Specialists Inc
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Tennessee
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Germantown, Tennessee, 미국, 38138
- Gastro One
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Nashville, Tennessee, 미국, 37212
- Vanderbilt University Medical Center
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Texas
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Tyler, Texas, 미국, 75701
- Tyler Research Institute, LLC
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Washington
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Seattle, Washington, 미국, 98122
- Swedish Medical Center
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Brussels, 벨기에, 1070
- Hopital Erasme
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Genk, 벨기에, 3600
- Ziekenhuis Oost-Limburg
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Leuven, 벨기에, 3000
- UZ Leuven
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Liège, 벨기에, B-4000
- CHU Sart Tilman
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Dammam, 사우디 아라비아, 31444
- King Fahad Specialist hospital
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Jeddah, 사우디 아라비아, 21423
- King Abdulaziz Medical City
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Riyadh, 사우디 아라비아, 12713
- King Faisal Specialist Hospital & Research Center
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Riyadh, 사우디 아라비아, 11472
- King Saud University Medical City
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Barcelona, 스페인, 08036
- Hosp Clinic de Barcelona
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Ferrol, 스페인, 15405
- Hosp. Arquitecto Marcide
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Girona, 스페인, 17007
- Hosp. Univ. Dr. Josep Trueta
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Madrid, 스페인, 28006
- Hosp. Univ. de La Princesa
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Majadahonda, 스페인, 28222
- Hosp. Univ. Pta. de Hierro Majadahonda
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Seville, 스페인, 41009
- Hosp. Virgen Macarena
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Vigo, 스페인, 36312
- Hosp. Alvaro Cunqueiro
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Zaragoza, 스페인, 50009
- Hosp. Univ. Miguel Servet
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Hull, 영국, HU3 2JZ
- Hull University Teaching Hospitals NHS Trust
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London, 영국, SW17 0QT
- St Georges University Hospital NHS Foundation Trust
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London, 영국, SE1 9RT
- Guys and St Thomas NHS Foundation Trust
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London, 영국, HA1 3UJ
- London North West University Healthcare NHS Trust
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Newcastle upon Tyne, 영국, NE3 3HD
- Newcastle upon Tyne Hospitals NHS Foundation Trust
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Salford, 영국, M6 8HD
- Pennine Acute Hospitals NHS Trust
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Amman, 요르단, 11942
- Jordan University Hospital
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Amman, 요르단
- Abdali Hospital
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Amman, 요르단, 11194
- The Speciality Hospital (TSH) / Advanced Clinical Center
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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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Afula, 이스라엘, 1834111
- Haemek Medical Center
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Haifa, 이스라엘, 31096
- Rambam Medical Center
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Jerusalem, 이스라엘, 9103102
- Shaare Zedek Medical Center
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Petah Tikva, 이스라엘, 49100
- Rabin Medical Center Beilinson Campus
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Alexandria, 이집트, 21131
- Alexandria University Hospital
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Alexandria, 이집트, 21131
- Alexandria University Hospital 1
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Cairo, 이집트, 11451
- National Hepatology and Tropical Medicine Research Institute
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Cairo, 이집트, 11517
- Ain Shams University Hospital
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Giza, 이집트, 12613
- Cairo university
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Milan, 이탈리아, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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Negrar ( Ve), 이탈리아, 37024
- Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
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Pisa, 이탈리아, 56124
- Azienda Ospedaliera Universitaria Pisana
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Rho, 이탈리아
- Azienda Ospedaliera G.Salvini Ospedale di Rho
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Roma, 이탈리아, 00168
- Policlinico Universitario Agostino Gemelli
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Rozzano, 이탈리아, 20089
- Istituto Clinico Humanitas
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San Giovanni Rotondo, 이탈리아, 71013
- Casa Sollievo della Sofferenza
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Abiko, 일본, 270-1168
- KOKIKAI Tokatsu Tsujinaka Hospital
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Chikushino-shi, 일본, 818-8502
- Fukuoka University Chikushi Hospital
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Fukuoka, 일본, 814 0180
- Fukuoka University Hospital
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Fukuoka, 일본, 807-8555
- Hospital of the University of Occupational and Environmental Health
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Fukuoka-ken, 일본, 802-0077
- Kitakyushu Municipal Medical Center
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Hiroshima, 일본, 734 8551
- Hiroshima University Hospital
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Kagoshima, 일본, 892-0846
- Sameshima Hospital
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Kashihara, 일본, 634-8521
- Nara Medical University Hospital
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Kashiwa, 일본, 277-0871
- Tsujinaka Hospital Kashiwanoha
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Nagasaki, 일본, 852-8501
- Nagasaki University Hospital
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Nagoya, 일본, 457-8511
- Kojunkai Daido Clinic
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Nagoya, 일본, 466 8560
- Nagoya University Hospital
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Nishinomiya, 일본, 663-8501
- The Hospital of Hyogo College of Medicine
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Okayama, 일본, 700 8558
- Okayama University Hospital
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Osaka, 일본, 530-0011
- Kinshukai Infusion Clinic
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Sakai, 일본, 591-8025
- JOHAS Osaka Rosai Hospital
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Sapporo, 일본, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Shinjuku-ku, 일본, 169-0073
- Tokyo Yamate Medical Center
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Shizuoka, 일본, 432-8061
- Matsuda Hospital
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Suita, 일본, 565 0871
- Osaka University Hospital
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Tokyo, 일본, 181 8611
- Kyorin University Hospital
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Toyota, 일본, 470-1219
- Ieda Hospital
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Tsu, 일본, 514 8507
- Mie University Hospital
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Yokkaichi, 일본, 510-0016
- Yokkaichi Hazu Medical Center
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Yokohama, 일본, 221 0855
- Yokohama Municipal Citizen's Hospital
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Prague, 체코, 170 04
- ISCARE a.s.
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České Budějovice, 체코, 37001
- Nemocnice Ceske Budejovice a s
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Alberta
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Edmonton, Alberta, 캐나다, T6G 2X8
- University of Alberta- Ziedler Ledcor Centre
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H2Y9
- Nova Scotia Health Authority
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Ontario
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London, Ontario, 캐나다, N6A 5A5
- London Health Sciences Centre
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Toronto, Ontario, 캐나다, M5G 1X5
- Mount Sinai Hospital
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Quebec
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Montreal, Quebec, 캐나다, H3G 1A4
- McGill University Health Centre
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Ankara, 터키 (Türkiye), 06560
- Gazi University Medical Faculty
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Istanbul, 터키 (Türkiye), 34098
- Istanbul University Cerrahpasa Medical Faculty
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Istanbul, 터키 (Türkiye), 34734
- Acibadem Kozyatagi Hospital
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Izmir, 터키 (Türkiye), 35100
- Ege University Medical Faculty
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Mersin, 터키 (Türkiye), 33110
- Mersin University Medical Faculty Hospital
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Braga, 포르투갈, 4710-243
- Uls Braga - Hosp. Braga
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Lisbon, 포르투갈, G1R 2J6
- Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
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Porto, 포르투갈, 4099-001
- H. Santo António - Centro Hospitalar do Porto
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Bialystok, 폴란드, 15-322
- Gastromed Kralisz Romatowski Stachurska Sp. j.
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Krakow, 폴란드, 31-513
- Centrum Medyczne Promed
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Lodz, 폴란드, 91 034
- Centrum Medyczne Med Gastr
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Rzeszów, 폴란드, 35-326
- Centrum Medyczne Medyk
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Szczecin, 폴란드, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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Torun, 폴란드, 87 100
- GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
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Warsaw, 폴란드, 00-728
- WIP Warsaw IBD Point Profesor Kierkus
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Wroclaw, 폴란드, 52-416
- Centrum Medyczne Oporow
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Wroclaw, 폴란드, 50-449
- Melita Medical Sp. z o.o.
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Neuilly-sur-Seine, 프랑스, 92200
- Clinique Ambroise Pare
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Nice, 프랑스, 06202
- CHU de Nice Hopital de l Archet
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Paris, 프랑스, 75014
- Hopital Saint Joseph
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Pierre-Bénite, 프랑스, 69495
- Centre Hospitalier Lyon Sud
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Rennes, 프랑스, 35033
- CHRU Hopital de Pontchaillou
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Vandœuvre-lès-Nancy, 프랑스, 54511
- CHRU Nancy Brabois
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Budapest, 헝가리, 1062
- Magyar Honvedseg Egeszsegugyi Kozpont
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Budapest, 헝가리, 1082
- Semmelweis Egyetem
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Budapest, 헝가리, 1083
- Semmelweis Egyetem 2
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Budapest, 헝가리, H-1088
- Semmelweis Egyetem 1
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Pécs, 헝가리, 7624
- Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
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Szeged, 헝가리, 6725
- Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp
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Adelaide, 호주, 5042
- Flinders Medical Centre
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Fitzroy, 호주, 3065
- St Vincent's Hospital - Melbourne
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Liverpool, 호주, 2170
- Liverpool Hospital
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Murdoch, 호주, 6150
- Fiona Stanley Hospital
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Newtown, 호주, 2042
- Royal Prince Alfred Hospital
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North Terrace, 호주, 5000
- Royal Adelaide Hospital
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Parkville, 호주, 3050
- Royal Melbourne Hospital
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Perth, 호주, 6000
- Royal Perth Hospital
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South Brisbane, 호주, 4101
- Mater Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months
- Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results
- Has previously demonstrated lack of initial response (that is primary non-responders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes of advanced drug therapies at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents) or JAK inhibitors licensed for Crohn's disease treatment (that is, upadacitinib)
Exclusion Criteria:
- Has a very severe luminal disease activity
- History of concurrent rectovaginal fistulas (other types of concurrent fistula should be confirmed with the sponsor), rectal and/or anal stenosis, stoma or functioning ostomy (include all current stoma types abscess or collections which are not properly drained) colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus
- Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation
- Any medical contraindications preventing study participation
- Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Group 1: Guselkumab
Participants will receive guselkumab Dose 1 intravenous (IV) infusion followed by Dose 2 subcutaneously (SC). Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) period and continue to receive guselkumab. |
Guselkumab will be administered subcutaneously/IV infusion.
다른 이름들:
Matching placebo will be administered subcutaneously/IV infusion. |
|
실험적: Group 2: Guselkumab
Participants will receive guselkumab Dose 1 IV infusion followed by Dose 3 SC. Participants will receive matching placebo to maintain the blind. At Week 24, guselkumab Dose 3 SC non-responders will switch to receive guselkumab dose 2 SC. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab. |
Guselkumab will be administered subcutaneously/IV infusion.
다른 이름들:
Matching placebo will be administered subcutaneously/IV infusion. |
|
실험적: Group 3: Placebo
Participants will receive placebo IV infusion followed by placebo SC. At Week 24, placebo non-responders will continue to receive guselkumab Dose 4 followed by guselkumab Dose 2 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab. |
Guselkumab will be administered subcutaneously/IV infusion.
다른 이름들:
Matching placebo will be administered subcutaneously/IV infusion. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants who Achieve Combined Fistula Remission at Week 24
기간: Week 24
|
Percentage of participants who achieve combined fistula remission at Week 24 will be reported. Combined fistula remission is defined as 100 percentage (%) closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings [occurring spontaneously or after gentle finger compression] and absence of collections greater than (>) 2 centimeters (cm) of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the magnetic resonance imaging [MRI] results. |
Week 24
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants who Achieve Combined Fistula Remission at Week 48
기간: Week 48
|
Percentage of participants who achieve combined fistula remission at Week 48 will be reported. |
Week 48
|
|
Percentage of Participants who Achieve Clinically Assessed Fistula Remission
기간: Week 24
|
Percentage of participants who achieve clinically assessed fistula remission will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. |
Week 24
|
|
Percentage of Participants who Achieve Radiological Fistula Remission Based on Radiological Findings Assessed by MRI
기간: Week 24
|
Percentage of participants who achieve radiological fistula remission based on radiological findings assessed by MRI will be reported. Radiological remission is defined as absence of collections >2 cm of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the MRI results. |
Week 24
|
|
Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 24
기간: Week 24
|
Percentage of participants who achieve clinically assessed fistula response at Week 24 will be reported. Clinically assessed fistula response is defined as a greater than or equal to (>=) 50% reduction from baseline in number of open or draining perianal fistulas. |
Week 24
|
|
Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 12
기간: Week 12
|
Percentage of participants who achieve clinically assessed fistula response at Week 12 will be reported. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas. |
Week 12
|
|
Change from Baseline in Crohn's Disease Activity Index (CDAI) by Visit Over Time Through Week 48
기간: Baseline up to Week 48
|
Change from baseline in CDAI by visit over time will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain (AP)/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being with scores ranging from 0 to approximately 600. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on a daily basis. |
Baseline up to Week 48
|
|
Percentage of Participants who Achieve Clinical Remission (CDAI less than [<] 150) by Visit Over Time Through Week 48 Among Participants with CDAI Greater than (>) 150 at Baseline
기간: Through Week 48
|
Percentage of participants who achieve clinical remission (CDAI <150) by visit over time through Week 48 among participants with CDAI >150 at baseline will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain [AP]/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being with scores ranging from 0 to approximately 600. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on a daily basis. |
Through Week 48
|
|
Percentage of Participants who Achieve a Clinical Response by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline
기간: Through Week 48
|
Percentage of participants who achieve a clinical response by visit over time through Week 48 among participants with CDAI >150 at baseline will be reported. Clinical response is defined greater than or equal to (>=) 100-point reduction from baseline in CDAI, or CDAI <150. |
Through Week 48
|
|
Percentage of Participants who Achieve Steroid-free Clinical Remission by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline
기간: Through Week 48
|
Percentage of participants who achieve steroid-free clinical remission by visit over time through Week 48 among participants with CDAI >150 at baseline will be reported. Steroid-free clinical remission is defined as CDAI <150 and not receiving corticosteroids by visit over time through Week 48 among participants with CDAI >150 at baseline. |
Through Week 48
|
|
Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response Among Participants With CDAI >220 at Baseline
기간: Week 24 and Week 48
|
Percentage of participants who achieve combined clinical response and clinically assessed fistula response among participants with CDAI >220 at baseline at baseline will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas. |
Week 24 and Week 48
|
|
Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline
기간: Week 24 and Week 48
|
Percentage of participants who achieve combined clinical remission and clinically assessed fistula remission among participants with CDAI >220 at baseline at will be reported. Clinical remission is defined as CDAI <150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. |
Week 24 and Week 48
|
|
Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline
기간: Week 24 and Week 48
|
Percentage of participants who achieve combined clinical response and clinically assessed fistula remission among participants with CDAI >220 at baseline will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. |
Week 24 and Week 48
|
|
Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response among Participants with CDAI >220 at Baseline
기간: Week 24 and Week 48
|
Percentage of participants who achieve combined clinical remission and clinically assessed fistula response among participants with CDAI >220 at baseline will be reported. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas. |
Week 24 and Week 48
|
|
Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response at Week 24 and Week 48
기간: Week 24 and Week 48
|
Percentage of participants who achieve combined clinical response and clinically assessed fistula response at Week 24 and Week 48 will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas. |
Week 24 and Week 48
|
|
Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission at Week 24 and Week 48
기간: Week 24 and Week 48
|
Percentage of participants who achieve combined clinical response and clinically assessed fistula remission at Week 24 and Week 48 will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. |
Week 24 and Week 48
|
|
Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response at Week 24 and Week 48
기간: Week 24 and Week 48
|
Percentage of participants who achieve combined clinical remission and clinically assessed fistula response at Week 24 and Week 48 will be reported. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas. |
Week 24 and Week 48
|
|
Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission at Week 24 and Week 48
기간: Week 24 and Week 48
|
Percentage of participants who achieve combined clinical remission and clinically assessed fistula remission will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. |
Week 24 and Week 48
|
|
Change from Baseline in Perianal Disease Activity Index (PDAI) Overall Score, Discharge Score, and Pain Score by Visit Over Time Through Week 48
기간: Baseline up to Week 48
|
Change from baseline in PDAI overall score, discharge score, and pain score by visit over time through Week 48 will be reported. The PDAI is a scoring system to evaluate the severity of perianal lesion associated with Crohn's disease. It includes the following 5 items: (a) Discharge; (0=no discharge to 4= Gross fecal soiling) (b) Pain; (0=no activity to 4= severe pain, severe limitation) (c) Restriction of sexual activity;(0=no perianal disease/skin tags to 4= unable to engage in sexual activity) (d) Type of perianal disease; (0=no perianal disease/skin tags to 4=Anal sphincter ulceration or fistulae with significant undermining ok skin) and (e) Degree of induration; (0=no induration to 4=gross fluctuance/abscess. Higher scores indicate more severe or active disease. |
Baseline up to Week 48
|
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Percentage of Participants who Achieve Clinically Assessed Fistula Response by Visit Over Time Through Week 48
기간: Through Week 48
|
Percentage of participants with clinically assessed fistula response by visit over time through Week 48 will be reported. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas. |
Through Week 48
|
|
Percentage of Participants who Achieve Clinically Assessed Fistula Remission by Visit over Time Through Week 48
기간: Through Week 48
|
Percentage of participants with clinically assessed fistula remission by visit over through Week 48 time will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. |
Through Week 48
|
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Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among the Participants who Achieve Clinical Fistula Remission at Week 24
기간: Week 48
|
Percentage of participants who achieve clinically assessed fistula remission at Week 48 among the participants who achieve clinical fistula remission at Week 24 will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. |
Week 48
|
|
Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among Those who Achieve Fistula Remission or Response at Week 24
기간: Week 48
|
Percentage of participants achieving clinically assessed fistula remission at Week 48 among those who achieve fistula remission or response (defined either by clinical or radiological assessment) at Week 24 will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. |
Week 48
|
|
Time to Clinical Fistula Remission
기간: Up to Week 96
|
Time to clinical fistula remission will be reported. Clinical fistula remission is defined as 100% closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings (occurring spontaneously or after gentle finger compression). |
Up to Week 96
|
|
Percentage of Participants who Achieve Radiological Fistula Predominantly Fibrotic Status for all Existent Fistulas Assessed by MRI at Week 24 and Week 48
기간: Week 24 and Week 48
|
Percentage of participants who achieve radiological fistula predominantly fibrotic status for all existent fistulas assessed by MRI at Week 24 and Week 48 will be reported. |
Week 24 and Week 48
|
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Percentage of participants who Achieve Radiological Remission Based on Radiological Findings Assessed by MRI at Week 48
기간: Week 48
|
Percentage of participants with radiological remission based on radiological findings assessed by MRI at Week 48 will be reported. Radiological remission is defined as absence of collections >2 cm of the perianal fistulas, confirmed by a blinded central review of the MRI results. |
Week 48
|
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Percentage of Participants who Achieve Radiological Remission Assessed by MRI at Week 48 Among the Participants who Achieve Radiological Remission at Week 24
기간: Week 48
|
Percentage of participants who achieve radiological remission assessed by MRI at Week 48 among the participants who achieve radiological remission at Week 24 will be reported. Radiological remission is defined as absence of collections >2 cm of the perianal fistulas, confirmed by a blinded central review of the MRI results. |
Week 48
|
|
Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission at Week 48 Among the Participants who Achieve Combined Clinical and Radiological Fistula Remission at Week 24
기간: Week 48
|
Percentage of participants who achieve combined clinically assessed and radiological (assessed by MRI) fistula remission at Week 48 among the participants who achieve combined clinical and radiological fistula remission at Week 24. |
Week 48
|
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Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission at Week 48 Among the Participants with Clinical Fistula Response at Week 24
기간: Week 48
|
Percentage of participants who achieve combined clinically assessed and radiological (assessed by MRI) fistula remission at Week 48 among the participants who achieve clinical fistula response at Week 24 will be reported. |
Week 48
|
|
Percentage of Participants with Proctitis at Week 48 Among Participants with MRI-confirmed Proctitis at Baseline
기간: Week 48
|
Percentage of participants with proctitis at Week 48 among participants with MRI-confirmed proctitis at baseline will be reported. Proctitis is defined as the inflammation of the lining of the rectum. |
Week 48
|
|
Change from Baseline in Magnetic Resonance Novel Index for Fistula imaging in Crohn's disease (MAGNIFI-CD) by Visit Over Time Through Week 48
기간: Baseline up to Week 48
|
Change from baseline in MAGNIFI-CD by visit over time through Week 48 will be reported. The MAGNIFI-CD is based on MRI assessment of 6 items including number of fistula tracts, fistula length, hyperintensity of primary tract on post-contrast T1-weighted images, dominant feature, extension, and inflammatory mass. The total MAGNIFI-CD score ranges from 0 (no disease activity) to 25 (severe disease activity). It assesses the MRI data and determines perianal fistulizing CD activity with improved operating characteristics compared to the Van Assche Index (VAI) and the modified VAI (mVAI). |
Baseline up to Week 48
|
|
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by Visit Over Time Through Week 48
기간: Baseline up to Week 48
|
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by visit over time through Week 48 will be reported. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD to evaluate patient reported outcomes (PROs) across 4 dimensions: bowel symptoms (loose stools, AP), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes. |
Baseline up to Week 48
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score by Visit Over Time Through Week 48
기간: Baseline; Up to Week 48
|
Change From baseline in FACIT-F Score at Week 48 will be reported. The FACIT-F is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists of 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score is calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. |
Baseline; Up to Week 48
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Crohn's Disease (WPAI:CD) by Visit Over Time Through Week 48
기간: Baseline; Up to Week 48
|
Change from baseline in WPAI:CD by visit over time through Week 48 will be reported. The WPAI:CD assesses the impact of CD on work and activity during the past 7 days. The specificity of WPAI:CD is achieved by replacing "health problems" in the general health version of the WPAI with "CD." It consists of 6 questions, which elicit the following information: employment status; hours missed due to CD; hours missed due to other reasons; hours actually worked; the degree to which CD affected productivity while working from 0 (no effect) to 10 (maximum impairment); and the degree to which CD affected regular activities (from 0-10). The sum of worktime missed and impairment at work yields the overall work impairment (productivity loss) score; scores are expressed as percent of impairment/productivity loss, with higher scores indicating greater impairment. |
Baseline; Up to Week 48
|
|
Change from Baseline in Quality-of-life as Assessed by European Quality-of-Life Five Dimension Five Level Scale (EQ5D-5L) Score by Visit Over Time Through Week 48
기간: Baseline up to Week 48
|
Change from baseline in quality-of-life (EQ5D-5L) score by visit over time through Week 48 will be reported. The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). |
Baseline up to Week 48
|
|
Change from Baseline in the Jorge-Wexner Score by Visit Over Time Through Week 48
기간: Baseline; Through Week 48
|
Change from baseline in the Jorge-Wexner score by visit over time through Week 48 will be reported. The Jorge-Wexner scoring system cross-tabulates frequencies and different anal incontinence presentations. |
Baseline; Through Week 48
|
|
Change from Baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by Visit Over Time Through Week 48
기간: Baseline; Through Week 48
|
Change from baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by visit over time through Week 48 will be reported. The IBD-DI consists of 28 items that evaluate the 5 domains of overall health, body function, body structures, activity participation and environmental factors. Each item response is graded from 0 to 4 for each area evaluated (0 = very good; 1 = Good; 2 = medium; 3 = Bad; 4 = Very bad). The final composite score representative of the overall degree of disability ranging from -80 (maximum degree of disability) to 22 (no disability). |
Baseline; Through Week 48
|
|
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
기간: Up to Week 48 and Week 96
|
An adverse event (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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. |
Up to Week 48 and Week 96
|
|
Number of Participants with Treatment-emergent Serious Adverse Events (TESAEs)
기간: Up to Week 48 and Week 96
|
An serious adverse event (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. TESAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state. |
Up to Week 48 and Week 96
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- CR109189
- 2021-000491-10 (EudraCT 번호)
- CNTO1959CRD3005 (기타 식별자: Janssen Research & Development, LLC)
- 2023-504740-33-00 (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
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