TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS (NCT06625450) | Clinical Trial Compass
Not Yet RecruitingPhase 4
TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS
75 participantsStarted 2024-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed cases of UC by endoscopy and biopsy
* Patients in clinical remission for at least 3 months on Tofacitinib and mesalamine
Exclusion Criteria:
* Incomplete evaluation
* Uncertain diagnosis
* Active disease
* Subjects with Crohn's disease, microscopic colitis and collegenous colitis or IBD-U
* Unwilling to participate in study
* Pregnant and lactating women or those who are planning pregnancy in the forthcoming 2 years
* Patients with any suspected or proven malignancy
* Subjects with severe comorbidities
* Prior history of venous thromboembolism.
* Subjects undergoing major surgery
* Myocardial infarction within previous 3 months
* Heart failure
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to relapse of colitis
Timeframe: 12 months
Trial details
NCT IDNCT06625450
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh