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NOT YET RECRUITING
NCT05112263
NA

Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis

Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

View on ClinicalTrials.gov

Summary

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

Official title: Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis: An Open Label Randomized Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2023-07-01

Completion Date

2026-06-01

Last Updated

2023-03-29

Healthy Volunteers

No

Interventions

DRUG

Tofacitinib

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

DRUG

Cyclosporine

: 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