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NCT06625450
TOFACITINIB COMPARED TO TOFACITINIB WITH MESALAMINE FOR MAINTENANCE OF REMISSION IN ULCERATIVE COLITIS: A RANDOMIZED CONTROLLED TRIAL
Phase 4 trial testing Tofacitinib in Ulcerative Colitis in 75 participants. Not yet recruiting.
1 December 2025
Quick facts
| Lead sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 1 October 2024 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 January 2026 |
Drugs / interventions tested
- Tofacitinib (tofacitinib) — full drug profile →
- Tofacitinib plus mesalamine — full drug profile →
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Who can join
18 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Time to relapse of colitis
Time frame: 12 months
Relapse of ulcerative colitis will be diagnosed based on the study subject's clinical findings
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Damage-associated molecular patterns (DAMPs) in diseases: implications for therapy.
Lin H, Xiong W, Fu L, Yi J, et al · · 2025 · cited 17× · PMID 40877572 · DOI 10.1186/s43556-025-00305-3
Verify or expand the search:
- PubMed search for NCT06625450
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
- NCT07297069 — Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial · Phase 2 · not yet recruiting
Other recruiting trials for Ulcerative Colitis
Currently open trials in the same condition.
- NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
- NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
- NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
- NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
- NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Other Post Graduate Institute of Medical Education and Research, Chandigarh trials
Trials by the same sponsor.
- NCT07322237 — DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis · Phase 4 · recruiting
- NCT07436988 — Affordable Made-in-India Microspheres for Liver Cancer Therapy · Phase 1 · not yet recruiting
- NCT07286643 — Echocardiography-guided Cirrhosis and Liver Failure-Intensive Care Protocol Sepsis · NA · recruiting
- NCT07280390 — Microplastics, Cirrhosis and Portal Hypertension · not yet recruiting
- NCT07182877 — Comparison of Dwell Time of Open Versus Closed Type Peripheral Intravenous Cannula · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06625450 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Post Graduate Institute of Medical Education and Research, Chandigarh
- Last refreshed: 2 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06625450.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing