672
Participants
Start Date
February 18, 2020
Primary Completion Date
March 31, 2026
Study Completion Date
March 31, 2026
Treatment Algorithm A
Participants who are not on UC treatment at screening (or who have only used topical therapy) will require standard first-line therapy. Either oral 5-ASA and/or immunosuppressive (azathioprine, 6-mercaptopurine, or methotrexate), with optional oral corticosteroid up to a maximum of 30 mg or prednisone or equivalent, will be initiated.
Treatment Algorithm B
"Participants who are taking oral 5-ASA, immunosuppressive (azathioprine, 6-mercaptopurine, methotrexate), and/or oral corticosteroid at screening will follow the treatment algorithm.~Participants will change to intravenous vedolizumab therapy.~Participants will be assessed to determine it remission target is achieved at weeks 16, 32 and 48. If the participant has achieved their treatment target, they will continue that line of therapy. If the participant has not achieved their treatment target, treatment and/or dose escalation will be administered according to the algorithm."
Treatment Algorithm C
"Participants who are taking a TNFα antagonist (infliximab, golimumab, or adalimumab), tofacitinib, or ustekinumab therapy at screening will follow the treatment algorithm.~Participants will change to intravenous vedolizumab therapy.~Participants will be assessed to determine it remission target is achieved at weeks 16, 32 and 48. If the participant has achieved their treatment target, they will continue that line of therapy. If the participant has not achieved their treatment target, treatment and/or dose escalation will be administered according to the algorithm."
Imelda Ziekenhuis Bonheiden, Bonheiden
UZ Leuven - University Hospital Gasthuisberg, Leuven
University Hospital Ghent, Ghent
Icahn School of Medicine at Mt Sinai Hospital, New York
New York-Presbyterian/Weill Cornell Medical Center, New York
Istituto Clinico Humanitas, Rozzano
Ospedale San Raffaele S.r.I., Milan
CHU Besançon - Hôpital Jean Minjoz, Besançon
Atrium Health (Carolinas HealthCare), Charlotte
Digestive Health Partners - Asheville Gastroenterology Associate, Asheville
Gabinet Endoskopii Przewodu Pokarmowego, Krakow
CHU de Bordeaux - Hopital Haut Leveque - Groupe Hospitalier Sud, Pessac
CHRU Montpellier - Hopital Saint Eloi, Montpellier
Azienda Ospedaliera di Padova, Padua
Azienda Ospedaliera - Polyclinico Sant'Orsola-Malpighi, Bologna
CH Saint Etienne Hopital Nord, Saint-Priest-en-Jarez
St. Joseph Mercy Hospital/Huron Gastroenterology Associates, Ypsilanti
CHRU De Nancy - Hopital de Brabois, Vandœuvre-lès-Nancy
CHRU de Lille - Hopital Claude Huriez, Lille
City Clinical Hospital #9 Dept of Gastrosurgery SI Zaporizhzhia MA of PGE of MoHU, Zaporizhzhia
Szpital Miejski Sw. Jana Pawla II w Elblagu, Elblag
Vitebsk Regional Clinical Hospital, Vitebsk
Gomel Regional Clinical Hospital, Homyel
University of Calgary, Calgary
GIRI (GI Research Institute), Vancouver
Barrie GI Associates Inc., Barrie
McMaster University Medical Centre, Hamilton
London Health Sciences Centre - University Campus, London
LHSC - Victoria Hospital, London
ABP Research Services Corp., Oakville
Taunton Surgical Centre, Oshawa
Toronto Immune and Digestive Health Institute (TIDHI), Toronto
McGill University Health Centre (MUHC) Montreal General Hospital, Montreal
Policlinico Universitario Agostino Gemelli, Roma
Radboud University Nijmegen Medical Centre, Nijmegen
Catharina Hospital, Eindhoven
ETZ Hospital Tilburg, Tilburg
Amsterdam UMC - Academisch Medisch Centrum, Amsterdam
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszcz, Bydgoszcz
GASTROMED - Kopon, Zmudzinski I Wspolnicy Sp.j., Torun
WIP Warsaw IBD Point Profesor Kierkus, Warsaw
Endoskopia Sp. z.o.o., Sopot
Sonomed Sp. z o.o. - Centrum Medyczne, Szczecin
Oddział Gastroenterologiczny SP ZOZ w Łęcznej, Łęczna
Dniepropetrovsk State Medical Academy, Dnipro
Odesa Regional Clinical Hospital, Odesa
Ternopil City Communal Emergency Medical Care Hosp, Ternopil
Uzhhorod National University, Uzhhorod
Vinnytsia City Clinical Hospital #1, Dept of Gastroenterology, Vinnytsia
Vinnytsia M.I. Pyrohov Regional Clinical Hospital, Vinnytsia
Hampshire Hospitals NHS Foundation Trust - The Royal Hampshire County Hospital, Winchester
Oxford University Hospitals NHS Foundation - John Radcliffe Hospital, Headington
University Hospitals Birmingham NHS Foundation Trust (UHB) - Queen Elizabeth Hospital Birmingham, Birmingham
Russells Hall Hospital, Dudley
Hull & East Yorkshire NHS Trust, Hull
Barts Health NHS Trust / Whipps Cross University Hospital, Leytonstone
Barts Health NHS Trust - Royal London Hospital, London
University of Nottingham NHS Trust, Nottingham
Lead Sponsor
Takeda Development Center Americas, Inc.
INDUSTRY
Alimentiv Inc.
OTHER