Clinical Trial

TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS

Not Yet Recruiting Phase 4
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Record status
This record was last updated October 3, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
All the trials using tofacitinib for maintenance of remission in UC have allowed the use of concomitant therapies except glucocorticoids. Mesalamine, a drug used in mild-to-moderate UC is often continued in patients receiving other drugs for maintenance. In this study, we plan to compare the effect of withdrawing mesalamine and continuing monotherapy with tofacitinib versus continuing dual therapy with tofacitinib and mesalamine. We hypothesize that the continuation of tofacitinib monotherapy after withdrawing mesalamine will be as efficacious and safe as continuation of the combination in remission maintenance in UC.
Trial Details
NCT Number NCT06625450
Lead Sponsor Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions Ulcerative Colitis
Enrollment 75 participants
Start Date 2024-10
Primary Completion 2025-12 (estimated)
Study Completion 2026-01 (estimated)
Updated on ClinicalTrials.gov 2024-10-03