Clinical trial
Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis: An Open Label Randomized Study
Name
IEC/2021/000641
Description
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
Trial arms
Trial start
2023-07-01
Estimated PCD
2025-12-01
Trial end
2026-06-01
Status
Not yet recruiting
Treatment
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
Arms:
Group B
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
Arms:
Group A
Size
96
Primary endpoint
Treatment failure
14 weeks
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}
Updated at
2023-03-29
1 organization