Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Collaborator: All India Institute of Medical Sciences, New Delhi
• Treatments: Cyclosporine; Cyclosporins; Tofacitinib

Criteria

Inclusion Criteria:

Patients admitted with Acute severe ulcerative colitis as defined by Modified Truelove and Witts Criteria WITH Failure to respond to intravenous steroids (Hydrocortisone 100 mg IV QID OR IV Methylprednisolone 60 mg IV OD) as defined by

• 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

• Ongoing activity as defined by Partial Mayo Score of > 3 (rectal bleeding sub-score of >1)

• Decision to start second line therapy (within 5-7 days of starting intravenous steroids)

Exclusion Criteria:

• Age <18, Age > 65 years

• E1 disease (involvement distal to rectosigmoid junction only)

• Crohn's disease

• Contraindication to intravenous cyclosporine or oral tofacitinib

• Renal failure, uncontrolled hypertension, seizure disorder,and uncorrected hypomagnesemia (<1.5 mg/L)

• Previous thrombosis, or prothrombotic state, on oral contraceptive, history of herpes zoster, active TB, active hepatitis, past opportunistic infections, h/o diverticulitis, Age >50 plus at least one cardiac risk factor

• Patient wants treatment with intravenous infliximab or wants surgery

• Underlying sepsis or active infection (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