Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management
- Sponsor
- McMaster University
- Study ID
- NCT04925973
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Ulcerative Colitis Acute
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tofacitinib 10 MG [Xeljanz] — DRUGTofacitinib 10mg PO BID
Study Details
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.
Key Dates
- Start date
- Jun 1, 2021
- Status verified
- Oct 2023
- Primary completion
- Dec 31, 2023
- Completion
- Dec 31, 2023
Study Design
- Enrollment
- 24 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment armTofacitinib 10mg PO BID
Primary Outcome Measure
Clinical response at day 7 [ Time Frame: 7 days ]
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- Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative ColitisPHASE4 · Recruiting · Berinstein, Jeffrey · Ann Arbor, Michigan