Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis

NANot yet recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

July 1, 2023

Primary Completion Date

December 1, 2025

Study Completion Date

June 1, 2026

Conditions
Ulcerative Colitis
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

All Listed Sponsors
collaborator

All India Institute of Medical Sciences

OTHER

lead

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

NCT05112263 - Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis | Biotech Hunter | Biotech Hunter