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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
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
: 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
Treatment failure
I) At Day 7 Absence of clinical response at day 7 (as defined by Partial Mayo of \> 3) II) By Day 98 1. Relapse (Partial Mayo Score of 3 or more) between day 7 and day 98 requiring additional therapy 2. Absence of steroid free remission at 14 weeks (Mayo \< 2 with MES 1 or less) 3. Need for colectomy, third line medical rescue or biologics or mortality 4. Serious adverse effect needing interruption of treatment
Time frame: 14 weeks
Clinical response
Partial Mayo \<4
Time frame: 7 days
Absence of steroid free remission
Mayo score of more than 2 with endoscopic sub-score of more than 1
Time frame: day 98
Colectomy free survival
No need for colectomy
Time frame: 98 days
Time to clinical response
Partial Mayo of 3 or less
Time frame: 98 days
Endoscopic healing
Mayo endoscopic sub-score of 1 or less
Time frame: Day 98
Serious adverse effects
requiring hospitalization, cessation of treatment and events like cardiovascular events, pulmonary embolism, venous thrombosis, any infection, malignancy, gastrointestinal perforation
Time frame: 98 days
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