Real World Effectiveness and Safety of Tofacitinib for the Treatment of Patients with Moderate-to-Severe Ulcerative Colitis: A Multicentre Cohort Study
PI: Dr. Christopher Ma, University of Calgary
Dr. Talat Bessissow, McGill University
Dr. Brian Bressler, University of British Columbia
Dr. Remo Panaccione, University of Calgary
Dr. Farhad Peerani, University of Alberta
Dr. Vipul Jairath, Western University
Dr. Christopher Ma, University of Calgary
Determine the proportion of patients with moderate-to-severe UC achieving clinical and endoscopic remission with tofacitinib at 3, 6 and 12 months after treatment.
Multicentre retrospective observational cohort study: This will be a combined retrospective and prospective multicenter cohort study evaluating the effectiveness of tofacitinib for inducing and maintaining clinical and endoscopic remission, and the safety of tofacitinib, particularly with respect to serious adverse events that have been raised for this class of treatment.
University of Calgary
McGill University Health Centre/MUHC
McMaster/Hamilton Health Sciences Centre
London Health Sciences Centre/Western University
University of Alberta, Edmonton
University of Manitoba, Winnipeg
Ottawa Hospital Research Institute (OHRI)
Tofacitinib is an oral small molecule drug inhibiting Janus kinase, which controls downstream expression of inflammatory mediators implicated in IBD. Tofacitinib was demonstrated to be effective for induction and maintenance of remission in patients with moderate-to-severe UC. However, real-world data on the effectiveness and safety of tofacitinib are lacking. Robust real world evidence evaluating treatment patterns, clinical effectiveness, and safety outcomes of tofacitinib will inform routine clinical practice.
For more information on Inclusion & Exclusion Criteria, click here.
Anticipated sample size n=216
Anticipated start: Fall 2020
Anticipated end: Fall 2022
Reimbursement provided on a per patient basis. Additional sites are welcome! Please contact Christopher Ma at firstname.lastname@example.org.