TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS
Phase 4 · Testing Tofacitinib and Tofacitinib plus mesalamine · Sites not listed yet · Post Graduate Institute of Medical Education and Research, Chandigarh
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Tofacitinib (a drug) and Tofacitinib plus mesalamine (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Diagnosed cases of UC by endoscopy and biopsy
- Patients in clinical remission for at least 3 months on Tofacitinib and mesalamine
There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 75 participants are expected to take part.
- Start date: 2024-10 (planned).
- Main results expected around 2025-12 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Time to relapse of colitis (12 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh |
| Enrollment | 75 (estimated) |
| Start date | 2024-10 |
| Primary completion (est.) | 2025-12 |
| First posted | 2024-10-03 |
| Last updated | 2024-10-03 |
| Official title | TOFACITINIB COMPARED TO TOFACITINIB WITH MESALAMINE FOR MAINTENANCE OF REMISSION IN ULCERATIVE COLITIS: A RANDOMIZED CONTROLLED TRIAL |
| ClinicalTrials.gov ID | NCT06625450 |
Interventions
- Tofacitinib (Drug)
Tofacitinib alone will be continued at a dose of 11 mg once a day - Tofacitinib plus mesalamine (Drug)
Both tofacitinib 11 mg once a day and mesalamine will be continued
Full eligibility criteria (from the record)
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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.