Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis

Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Study ID
NCT05112263
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    For the tofacitinib the dose of 10 mg BD will be administered for 8 weeks (10 mg TDS for initial three days) and then reduced to 5 mg BD for the period of study
  • Cyclosporine — DRUG
    : Intravenous Cyclosporine 2 mg/kg continuous infusion for 5-7 days and then shifted to oral cyclosporine 4 mg/kg/day in two divided doses for 12 weeks.Those who respond with intravenous cyclosporine will be shifted to oral cyclosporine 4 mg/kg for 12 weeks while the thiopurine dose is adjusted to the patient's weight

Study Details

This randomised trial plans to compare oral tofacitinib with intravenous cyclosporine in patients with acute severe ulcerative colitis who have failed to respond to intravenous steroids

Key Dates

Start date
Jul 1, 2023
Status verified
Mar 2023
Primary completion
Dec 1, 2025
Completion
Jun 1, 2026

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A
    Group A: Intravenous Cyclosporine 2 mg/kg continuous infusion for 5-7 days and then shifted to oral cyclosporine 4 mg/kg/day in two divided doses for 12 weeks
  • Experimental: Group B
    Oral Tofacitinib 10 mg TDS for 3 days, and then 10 mg BD to complete 8 weeks followed by 5 mg BD till follow-up (14 weeks)

Primary Outcome Measure

Treatment failure [ Time Frame: 14 weeks ]

Central Contacts

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