drugset / Trial / NCT06625450
TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS
Phase 4
Not yet recruiting
75 enrolled
Post Graduate Institute of Medical Education and Research, Chandigarh
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2024-10
- Primary completion
- 2025-12
- Completion
- 2026-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mesalamine | Small molecule | — | — |
| Comparator | Tofacitinib | Small molecule | 11 mg | — |