Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Placebo replacing Tofacitinib
5-ASA to continue: Participants will continue oral 5-Aminosalicylates at a stable dose, with placebo replacing tofacitinib, for the study duration. This g
Sponsors
Dayanand Medical College and Hospital, Ludhiana, Punjab
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older with a confirmed diagnosis of ulcerative colitis based on standard clinical, endoscopic, and histological criteria as per ECCO guidelines. 2. Composite remission at enrolment, defined as: a) Clinical remission, indicated by a Partial Mayo Clinic score of less than or equal to 1 with no individual sub-score greater than 1 and a rectal bleeding sub-score of 0, together with biochemical remission demonstrated by fecal calprotectin levels less than 250 micrograms per gram on two different occassions three months apart. b) Endoscopic remission, defined as ulcerative colitis endoscopic index of severity (UCEIS) of 0 or 1 within three months of enrolment. 3. Stable maintenance therapy with both 5-aminosalicylates and tofacitinib 5 mg twice daily for at least three months prior to enrolment. 4. Willingness to provide informed consent. 5. Willingness to comply with study procedures, assessments, and follow-up.
Exclusion criteria
Exclusion criteria: 1. Evidence of active disease at the time of enrolment (clinical, biochemical, or endoscopic activity). 2. Use of systemic corticosteroids, biologics, or immunomodulators (e.g., azathioprine, methotrexate) within the last 3 months. 3. Change of therapy or change in dose of existing therapy for UC. 4. History of colorectal cancer, dysplasia, or colectomy. 5. Significant comorbidities, including severe hepatic, renal, cardiac, respiratory, psychological or neurological diseases. 6. Pregnancy, breastfeeding, or plans to conceive during the study period. 7. Active substance abuse, including alcohol, which may interfere with adherence to the study protocol. 8. Any condition or circumstance that, in the investigator’s opinion, would make the patient unsuitable for participation or interfere with the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients experiencing disease flare within 12 monthsTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to disease flare within 12 months 2. Proportion of patients recapturing clinical response at 8 weeks following therapy escalation 3. Proportion of patients maintaining symptomatic and biomarker remission at 12 months 4. Incidence of adverse events (AEs) and serious adverse events (SAEs) during the study periodTimepoint: All the groups will be assessed on efficacy outcomes at baseline and every 4 weeks till 48 weeks | — |
Countries
India
Contacts
Public ContactDr Ajit Sood
Dayanand Medical College and Hospital
Outcome results
None listed