Tofacitinib versus Cyclosporine for steroid refractory acute severe ulcerative colitis:An open label randomized study - TOCAS

Postgraduate Institute of Medical Education and Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

试验速览

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•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
•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)

•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

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