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TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS

NCT06625450 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-10-03

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2025-12-31
Completion
2026-01-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06625450 on ClinicalTrials.gov