The TRIUMPH study was designed to build on the existing literature by studying the efficacy of tofacitinib in hospitalized patients with acute severe ulcerative colitis. This trial will provide evidence for a possible new indication for the use of tofacitinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Tofacitinib 10mg PO BID
McMaster University
Hamilton, Ontario, Canada
Clinical response at day 7
To determine the effectiveness (combined and endoscopic response) and safety of tofacitinib in patients with acute severe UC who experience treatment failure to steroids or anti-TNFα/anti-integrin therapies/anti-interleukin therapies. The primary outcome of this study is to assess clinical response at day 7 among patients who receive tofacitinib. This will be determined by the percentage of patients who achieve clinical response at day 7 (MTWSI reduction 3 or more points and MTWSI \< 10).
Time frame: 7 days
1. Percentage of patients who achieve clinical remission at day 7, and weeks 12, 26, and 52 (Partial Mayo score < 2, with no subscore >1)
Time frame: 52 weeks
Number of colectomies (emergency and planned) during the 52 weeks
Time frame: 52 weeks
Number of patients requiring switch in therapy (i.e. initiation of another biological medication, start of a different clinical trial with another active drug, etc) during the 52 weeks
Time frame: 52 weeks
Percentage of patients who achieve clinical response at weeks 12, 26, and 52 (MTWSI reduction 3 or more points and MTWSI < 10)
Time frame: 52 weeks
For patients who have response, to determine the mean number of days before detection of clinically significant response (MTWSI reduction of 3 or more points) population.
Time frame: 7 days
To determine the rate of corticosteroid-free clinical remission based on Number of patients with initial Mayo 2/3 disease at flexible sigmoidoscopy that achieve endoscopic improvement (Mayo score 0 or 1) at week 26
Time frame: Week 26
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Comparison of absolute change from baseline endoscopic Mayo score at week 26
Time frame: Week 26
Comparison of number of patients with severe colitis based on histology who are able to achieve histological improvement (mild or inactive colitis) at week 26
Time frame: Week 26
Proportion of individuals who experience a severe adverse event over the course of treatment
Time frame: 52 weeks