En undersøgelse af Guselkumab hos deltagere med fistulerende, perianal Crohns sygdom (FUZION CD)
En fase 3, randomiseret, placebo-kontrolleret, parallel-gruppe, multicenter undersøgelse for at evaluere effektiviteten og sikkerheden af Guselkumab hos deltagere med fistulerende, perianal Crohns sygdom
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Adelaide, Australien, 5042
- Flinders Medical Centre
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Fitzroy, Australien, 3065
- St Vincent's Hospital - Melbourne
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Liverpool, Australien, 2170
- Liverpool Hospital
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Murdoch, Australien, 6150
- Fiona Stanley Hospital
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Newtown, Australien, 2042
- Royal Prince Alfred Hospital
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North Terrace, Australien, 5000
- Royal Adelaide Hospital
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Parkville, Australien, 3050
- Royal Melbourne Hospital
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Perth, Australien, 6000
- Royal Perth Hospital
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South Brisbane, Australien, 4101
- Mater Hospital
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Brussels, Belgien, 1070
- Hopital Erasme
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Genk, Belgien, 3600
- Ziekenhuis Oost-Limburg
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Leuven, Belgien, 3000
- UZ Leuven
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Liège, Belgien, B-4000
- CHU Sart Tilman
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Alberta
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Edmonton, Alberta, Canada, T6G 2X8
- University of Alberta- Ziedler Ledcor Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H2Y9
- Nova Scotia Health Authority
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Ontario
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre
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Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- McGill University Health Centre
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Hull, Det Forenede Kongerige, HU3 2JZ
- Hull University Teaching Hospitals NHS Trust
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London, Det Forenede Kongerige, SW17 0QT
- St Georges University Hospital NHS Foundation Trust
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London, Det Forenede Kongerige, SE1 9RT
- Guys and St Thomas NHS Foundation Trust
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London, Det Forenede Kongerige, HA1 3UJ
- London North West University Healthcare NHS Trust
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Newcastle upon Tyne, Det Forenede Kongerige, NE3 3HD
- Newcastle upon Tyne Hospitals NHS Foundation Trust
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Salford, Det Forenede Kongerige, M6 8HD
- Pennine Acute Hospitals NHS Trust
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Alexandria, Egypten, 21131
- Alexandria University Hospital
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Alexandria, Egypten, 21131
- Alexandria University Hospital 1
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Cairo, Egypten, 11451
- National Hepatology and Tropical Medicine Research Institute
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Cairo, Egypten, 11517
- Ain Shams University Hospital
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Giza, Egypten, 12613
- Cairo university
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Yale University
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Florida
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Miami, Florida, Forenede Stater, 33136
- University of Miami
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Naples, Florida, Forenede Stater, 34102
- Gastroenterology Group Of Naples
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Orlando, Florida, Forenede Stater, 32804
- AdventHealth Medical Group Blood & Marrow Transplant at Orlando
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- Kansas University Medical Center
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky Chandler Medical Center
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Louisville, Kentucky, Forenede Stater, 40202
- University of Louisville
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Washington University School Of Medicine
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New York
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New York, New York, Forenede Stater, 10029
- Mount Sinai School of Medicine
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Digestive Disease Specialists Inc
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- Gastro One
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Nashville, Tennessee, Forenede Stater, 37212
- Vanderbilt University Medical Center
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Texas
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Tyler, Texas, Forenede Stater, 75701
- Tyler Research Institute, LLC
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Washington
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Seattle, Washington, Forenede Stater, 98122
- Swedish Medical Center
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Neuilly-sur-Seine, Frankrig, 92200
- Clinique Ambroise Pare
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Nice, Frankrig, 06202
- CHU de Nice Hopital de l Archet
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Paris, Frankrig, 75014
- Hopital Saint Joseph
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Pierre-Bénite, Frankrig, 69495
- Centre Hospitalier Lyon Sud
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Rennes, Frankrig, 35033
- CHRU Hopital de Pontchaillou
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Vandœuvre-lès-Nancy, Frankrig, 54511
- CHRU Nancy Brabois
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Athens, Grækenland, 10676
- Evangelismos General Hospital of Athens
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Athens, Grækenland, 156 69
- Sotiria General State Hospital of Chest Diseases
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Athens, Grækenland, 11528
- Hippokration Hospital 1
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Athens Attica, Grækenland, 115 28
- Alexandra General Hospital of Athens
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Heraklion, Grækenland, 71110
- University Hospital of Heraklion
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Larissa, Grækenland, 41110
- University Hospital Of Larissa
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Pátrai, Grækenland, 26504
- Patras University Hospital
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Thessaloniki, Grækenland, 54642
- Hippokration Hospital
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Amsterdam, Holland, 1105 AZ
- Academisch Medisch Centrum Universiteit van Amsterdam
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Nijmegen, Holland, 6525 GA
- Radboudumc
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Rotterdam, Holland, 3015 CE
- Erasmus MC
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Utrecht, Holland, 3584 CX
- UMC Utrecht
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Afula, Israel, 1834111
- Haemek Medical Center
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Haifa, Israel, 31096
- Rambam Medical Center
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
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Petah Tikva, Israel, 49100
- Rabin Medical Center Beilinson Campus
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Milan, Italien, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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Negrar ( Ve), Italien, 37024
- Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
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Pisa, Italien, 56124
- Azienda Ospedaliera Universitaria Pisana
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Rho, Italien
- Azienda Ospedaliera G.Salvini Ospedale di Rho
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Roma, Italien, 00168
- Policlinico Universitario Agostino Gemelli
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Rozzano, Italien, 20089
- Istituto Clinico Humanitas
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San Giovanni Rotondo, Italien, 71013
- Casa Sollievo della Sofferenza
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Abiko, Japan, 270-1168
- KOKIKAI Tokatsu Tsujinaka Hospital
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Chikushino-shi, Japan, 818-8502
- Fukuoka University Chikushi Hospital
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Fukuoka, Japan, 814 0180
- Fukuoka University Hospital
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Fukuoka, Japan, 807-8555
- Hospital of the University of Occupational and Environmental Health
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Fukuoka-ken, Japan, 802-0077
- Kitakyushu Municipal Medical Center
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Hiroshima, Japan, 734 8551
- Hiroshima University Hospital
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Kagoshima, Japan, 892-0846
- Sameshima Hospital
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Kashihara, Japan, 634-8521
- Nara Medical University Hospital
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Kashiwa, Japan, 277-0871
- Tsujinaka Hospital Kashiwanoha
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Nagasaki, Japan, 852-8501
- Nagasaki University Hospital
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Nagoya, Japan, 457-8511
- Kojunkai Daido Clinic
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Nagoya, Japan, 466 8560
- Nagoya University Hospital
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Nishinomiya, Japan, 663-8501
- The Hospital of Hyogo College of Medicine
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Okayama, Japan, 700 8558
- Okayama University Hospital
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Osaka, Japan, 530-0011
- Kinshukai Infusion Clinic
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Sakai, Japan, 591-8025
- JOHAS Osaka Rosai Hospital
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Sapporo, Japan, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Shinjuku-ku, Japan, 169-0073
- Tokyo Yamate Medical Center
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Shizuoka, Japan, 432-8061
- Matsuda Hospital
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Suita, Japan, 565 0871
- Osaka University Hospital
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Tokyo, Japan, 181 8611
- Kyorin University Hospital
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Toyota, Japan, 470-1219
- Ieda Hospital
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Tsu, Japan, 514 8507
- Mie University Hospital
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Yokkaichi, Japan, 510-0016
- Yokkaichi Hazu Medical Center
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Yokohama, Japan, 221 0855
- Yokohama Municipal Citizen's Hospital
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Amman, Jordan, 11942
- Jordan University Hospital
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Amman, Jordan
- Abdali Hospital
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Amman, Jordan, 11194
- The Speciality Hospital (TSH) / Advanced Clinical Center
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Irbid, Jordan, 22110
- King Abdullah University Hospital
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Irbid, Jordan, 21110
- Irbid Specialty Hospital
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Bialystok, Polen, 15-322
- Gastromed Kralisz Romatowski Stachurska Sp. j.
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Krakow, Polen, 31-513
- Centrum Medyczne Promed
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Lodz, Polen, 91 034
- Centrum Medyczne Med Gastr
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Rzeszów, Polen, 35-326
- Centrum Medyczne Medyk
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Szczecin, Polen, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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Torun, Polen, 87 100
- GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
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Warsaw, Polen, 00-728
- WIP Warsaw IBD Point Profesor Kierkus
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Wroclaw, Polen, 52-416
- Centrum Medyczne Oporow
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Wroclaw, Polen, 50-449
- Melita Medical Sp. z o.o.
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Braga, Portugal, 4710-243
- Uls Braga - Hosp. Braga
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Lisbon, Portugal, G1R 2J6
- Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
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Porto, Portugal, 4099-001
- H. Santo António - Centro Hospitalar do Porto
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Dammam, Saudi Arabien, 31444
- King Fahad Specialist hospital
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Jeddah, Saudi Arabien, 21423
- King Abdulaziz Medical City
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Riyadh, Saudi Arabien, 12713
- King Faisal Specialist Hospital & Research Center
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Riyadh, Saudi Arabien, 11472
- King Saud University Medical City
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Barcelona, Spanien, 08036
- Hosp Clinic de Barcelona
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Ferrol, Spanien, 15405
- Hosp. Arquitecto Marcide
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Girona, Spanien, 17007
- Hosp. Univ. Dr. Josep Trueta
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Madrid, Spanien, 28006
- Hosp. Univ. de La Princesa
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Majadahonda, Spanien, 28222
- Hosp. Univ. Pta. de Hierro Majadahonda
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Seville, Spanien, 41009
- Hosp. Virgen Macarena
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Vigo, Spanien, 36312
- Hosp. Alvaro Cunqueiro
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Zaragoza, Spanien, 50009
- Hosp. Univ. Miguel Servet
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Busan, Sydkorea, 48108
- Inje University Haeundae Paik Hospital
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Daegu, Sydkorea, 42415
- Yeungnam University Hospital
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Gyeonggi-do, Sydkorea, 13620
- Seoul National University Bundang Hospital
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Seoul, Sydkorea, 03080
- Seoul National University Hospital
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Seoul, Sydkorea, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Changhua, Taiwan, 500
- Changhua Christian Hospital
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taoyuan City, Taiwan, 333
- Chang Gung Memorial Hospital Linkou Branch
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Prague, Tjekkiet, 170 04
- ISCARE a.s.
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České Budějovice, Tjekkiet, 37001
- Nemocnice Ceske Budejovice a s
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Ankara, Tyrkiet (Türkiye), 06560
- Gazi University Medical Faculty
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Istanbul, Tyrkiet (Türkiye), 34098
- Istanbul University Cerrahpasa Medical Faculty
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Istanbul, Tyrkiet (Türkiye), 34734
- Acibadem Kozyatagi Hospital
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Izmir, Tyrkiet (Türkiye), 35100
- Ege University Medical Faculty
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Mersin, Tyrkiet (Türkiye), 33110
- Mersin University Medical Faculty Hospital
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Berlin, Tyskland, 10117
- Charite - Campus Mitte
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Frankfurt, Tyskland, 60590
- JWG-University Hospital
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Kiel, Tyskland, 24105
- Universitatsklinikum Schleswig Holstein Kiel
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Mannheim, Tyskland, 68167
- Universitaetsklinikum Mannheim
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Ulm, Tyskland, 89081
- Universitaetsklinikum Ulm
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Budapest, Ungarn, 1062
- Magyar Honvedseg Egeszsegugyi Kozpont
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Budapest, Ungarn, 1082
- Semmelweis Egyetem
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Budapest, Ungarn, 1083
- Semmelweis Egyetem 2
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Budapest, Ungarn, H-1088
- Semmelweis Egyetem 1
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Pécs, Ungarn, 7624
- Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
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Szeged, Ungarn, 6725
- Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
Andre navne:
Matching placebo will be administered subcutaneously/IV infusion. |
|
Eksperimentel: 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.
Andre navne:
Matching placebo will be administered subcutaneously/IV infusion. |
|
Eksperimentel: 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.
Andre navne:
Matching placebo will be administered subcutaneously/IV infusion. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants who Achieve Combined Fistula Remission at Week 24
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants who Achieve Combined Fistula Remission at Week 48
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Through Week 48
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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
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Percentage of Participants who Achieve Clinically Assessed Fistula Remission by Visit over Time Through Week 48
Tidsramme: Through Week 48
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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
Tidsramme: 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
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Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among Those who Achieve Fistula Remission or Response at Week 24
Tidsramme: 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
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Time to Clinical Fistula Remission
Tidsramme: 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
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Percentage of Participants who Achieve Radiological Fistula Predominantly Fibrotic Status for all Existent Fistulas Assessed by MRI at Week 24 and Week 48
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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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
Tidsramme: 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
Tidsramme: 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
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Percentage of Participants with Proctitis at Week 48 Among Participants with MRI-confirmed Proctitis at Baseline
Tidsramme: 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
|
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Change from Baseline in Magnetic Resonance Novel Index for Fistula imaging in Crohn's disease (MAGNIFI-CD) by Visit Over Time Through Week 48
Tidsramme: Baseline up to Week 48
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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
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Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by Visit Over Time Through Week 48
Tidsramme: 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
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score by Visit Over Time Through Week 48
Tidsramme: 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
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Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Crohn's Disease (WPAI:CD) by Visit Over Time Through Week 48
Tidsramme: 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
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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
Tidsramme: 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
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Change from Baseline in the Jorge-Wexner Score by Visit Over Time Through Week 48
Tidsramme: 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
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Change from Baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by Visit Over Time Through Week 48
Tidsramme: 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
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Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Tidsramme: 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
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Number of Participants with Treatment-emergent Serious Adverse Events (TESAEs)
Tidsramme: 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
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR109189
- 2021-000491-10 (EudraCT nummer)
- CNTO1959CRD3005 (Anden identifikator: Janssen Research & Development, LLC)
- 2023-504740-33-00 (Registry Identifier: EUCT number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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