Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Tofacitinib arm: 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
Control Intervention1: Cyclosporine: Group A: I
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: Patients with acute severe ulcerative colitis as defined by Truelove Witts criteria Patients admitted with Acute severe ulcerative colitis as defined by Modified Truelove and Witts Criteria Stool frequency > 6/day with one of the following â?? Tachycardia ( >90/min) â?? Fever ( >37.8 C) â?? Anemia (Hb â?? ESR >30 or CRP > 30 mg/L Inclusion Criteria (All of the following) Failure to respond to intravenous steroids (Hydrocortisone 100 mg IV QID OR IV Methylprednisolone 60 mg IV OD) as defined by â?? Day 3 non-response as per Oxford criteria (stool frequency of > 8/day, OR stool frequency between 3-8 with CRP > 45 mg/L PLUS â?? Ongoing activity as defined by Partial Mayo Score of > 3 (rectal bleeding sub-score of >1) â?? Decision to start second line therapy (within 5-7 days of starting intravenous steroids)
Exclusion criteria
Exclusion criteria: E1 disease Crohns disease Contraindication to intravenous cyclosporine like Renal failure uncontrolled hypertension seizure disorder and uncorrected hypomagnesemia Contraindication to oral tofacitinib Previous thrombosis, or prothrombotic state, on oral contraceptive history of herpes zoster active TB active hepatitis past opportunistic infections past diverticulitis Age more than 50 plus at least one cardiac risk factor Patient wants treatment with intravenous infliximab or wants surgery Underlying sepsis or active infection like Enteric infections Clostridium difficile, active hepatitis B or C Tuberculosis zoster CMV disease Toxic megacolon previous dysplasia or any indication of immediate surgery Known malignancy Pregnancy or Lactation Unwilling to provide consent or for follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure : Treatment failure I) At Day 7 a) Absence of clinical response at day 7 as defined by Partial Mayo of more than 3 II) By Day 98 b) Relapse (Partial Mayo Score of 3 or more) between day 7 and day 98 requiring additional therapy c) Absence of steroid free remission at 14 weeks (Mayo 2 with MES 1 or less) d) Need for colectomy, third line medical rescue or biologics or mortality e) Serious adverse effect needing interruption of treatmentTimepoint: 14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Absence of steroid free remission at day 98 defined as Mayo score of more than 2 with endoscopic sub-score of more than 1Timepoint: 14 weeks;Clinical response as defined by Partial Mayo less than 4Timepoint: 7 days;Colectomy free survivalTimepoint: 14 weeks;Endoscopic healing at day 98 defined by Mayo sub-score of 1 or lessTimepoint: 14 weeks;Serious adverse effectsTimepoint: 14 weeks;Time to clinical response Partial Mayo of 3 or lessTimepoint: days | — |
Countries
India
Contacts
Public ContactVishal Sharma
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed