drugset / Trial / NCT06625450

TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS

NCT06625450

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

EvaluationDrugModalityDoseRoute
Comparator Mesalamine Small molecule
Comparator Tofacitinib Small molecule 11 mg

Indications