Comparison of oral Tofacitinib and intravenous cyclosporine in acute severe ulceerative colitis not responding to intravenous steroids

Not Applicable

Conditions: Health Condition 1: K519- Ulcerative colitis, unspecified

Registration Number: CTRI/2021/11/038082

Lead Sponsor: Postgraduate Institute of Medical Education and Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 <10.5 gram/dL)

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment failure <br/ ><br>: Treatment failure <br/ ><br>I) At Day 7 <br/ ><br>a) Absence of clinical response at day 7 as defined by Partial Mayo of more than 3 <br/ ><br>II) By Day 98 <br/ ><br>b) Relapse (Partial Mayo Score of 3 or more) between day 7 and day 98 requiring additional therapy <br/ ><br>c) Absence of steroid free remission at 14 weeks (Mayo 2 with MES 1 or less) <br/ ><br>d) Need for colectomy, third line medical rescue or biologics or mortality <br/ ><br>e) Serious adverse effect needing interruption of treatmentTimepoint: 14 weeks

Secondary Outcome Measures

Name	Time	Method
Absence of steroid free remission at day 98 defined as Mayo score of more than 2 with <br/ ><br>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