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Patients who received induction filgotinib were rerandomised 2:1 to continue their induction filgotinib regimen or to placebo. Patients who had either clinical remission or a Mayo Clinic Score response at week 10 in either induction study entered the maintenance study. Patients were randomly assigned 2:2:1 to receive oral filgotinib 200 mg, filgotinib 100 mg, or placebo once per day for 11 weeks. Eligible patients were aged 18-75 years with moderately to severely active ulcerative colitis for at least 6 months before enrolment (induction study A: inadequate clinical response, loss of response to or intolerance to corticosteroids or immunosuppressants, naive to tumour necrosis factor antagonists and vedolizumab induction study B: inadequate clinical response, loss of response to or intolerance to any TNF antagonist or vedolizumab, no TNF antagonist or vedolizumab use within 8 weeks before screening ).
THERAPY ED VERSION .6 TRIAL
This phase 2b/3, double-blind, randomised, placebo-controlled trial including two induction studies and one maintenance study was done in 341 study centres in 40 countries. We assessed the efficacy and safety of filgotinib, a once-daily, oral Janus kinase 1 preferential inhibitor, for treatment of ulcerative colitis. Electronic address: global prevalence of ulcerative colitis is increasing, and induction and maintenance of remission is a crucial therapeutic goal. 23 Department of Gastroenterology, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France.Electronic address: 2 IBD Center, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy Humanitas University, Pieve Emanuele, Milan, Italy. Electronic address: 1 Alimentiv, London, ON, Canada Division of Gastroenterology, London Health Sciences Centre, Western University, London, ON, Canada. 22 Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.21 University Hospital of Zurich, University of Zurich, Zurich, Switzerland.20 University of California San Diego, La Jolla, CA, USA.19 Tokyo Medical and Dental University, Tokyo, Japan.17 Gilead Sciences, Foster City, CA, USA.16 Center for Crohn's and Colitis, Kyung Hee University College of Medicine, Seoul, Republic of Korea.15 Norfolk and Norwich University Hospital, Norwich, UK.14 Crohn-Colitis Zentrum, Lindenhofspital, Bern, Switzerland.13 Hannover Medical School, Hannover, Germany.12 Ternopil National Medical University, Ternopil, Ukraine.11 Rzeszów University, Rzeszów, Poland.10 Wrocław Medical University, Wrocław, Poland.9 Shree Vihar, Jaipur, Rajasthan, India.8 SIDS Hospital, Vijaynagar, Gujarat, India.7 Henry Ford Macomb Hospitals, Clinton Township, MI, USA.5 University Hospital Schleswig-Holstein, Kiel, Germany.4 University Hospitals Leuven, Leuven, Belgium.3 Mayo Clinic College of Medicine, Rochester, MN, USA.1 Alimentiv, London, ON, Canada Division of Gastroenterology, London Health Sciences Centre, Western University, London, ON, Canada.