Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management (NCT04925973) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management
Canada24 participantsStarted 2021-06-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults ages 18 to 75 with ulcerative colitis (either known UC based on prior history with histological confirmation or new diagnosis)
✓. Symptoms consistent with severe acute ulcerative colitis as defined by modified Truelove and Witts score (MTWSI) \> 10 points
✓. Primary non-response or secondary loss of response to anti-TNFα/anti-integrin therapies/anti-interleukin therapies OR immunomodulators OR non-response to minimum 3 days and maximum of 7 days of intravenous corticosteroids (intravenous at dose equivalent of prednisone 50mg daily / methylprednisolone 40mg daily).
✓. Able to provide written informed consent
✓. Treatment with concomitant corticosteroids or 5-ASA products is permitted, however patients will be placed on a corticosteroid weaning regimen after initiating study protocols. For patients using biologics or immunomodulators, these will be discontinued prior to initiation of tofacitinib.
Exclusion criteria
✕. Enteric infection confirmed before inclusion into study by stool microscopy, culture, or histology (including Clostridum difficile, Campylobacter, Salmonella, Shigella, Cytomegalovirus, Human Immunodeficiency Virus, Epstein Bar Virus)
✕. Clinical signs of sepsis
✕. Patient has indication for surgery instead of medical rescue therapy (ex. toxic megacolon, massive exsanguination, or perforation)
✕. Positive blood (beta-HCG) pregnancy test or currently lactating, or women of childbearing potential not willing to use double barrier contraception for the duration of the active part of the study and for 4 weeks after the last dose of tofacitinib