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NOT YET RECRUITING
NCT06625450
PHASE4

TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS

Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

View on ClinicalTrials.gov

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.

Official title: TOFACITINIB COMPARED TO TOFACITINIB WITH MESALAMINE FOR MAINTENANCE OF REMISSION IN ULCERATIVE COLITIS: A RANDOMIZED CONTROLLED TRIAL

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2024-10

Completion Date

2026-01

Last Updated

2024-10-03

Healthy Volunteers

No

Interventions

DRUG

Tofacitinib

Tofacitinib alone will be continued at a dose of 11 mg once a day

DRUG

Tofacitinib plus mesalamine

Both tofacitinib 11 mg once a day and mesalamine will be continued