Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Nov 4, 2021

Keywords

ClinConnect Summary

This clinical trial is looking to compare two treatments for people with a serious condition called acute severe ulcerative colitis, which is a type of inflammatory bowel disease. Specifically, the researchers want to see how well an oral medication called tofacitinib works compared to an intravenous (IV) medication called cyclosporine in patients who have not responded to steroid treatments. This trial is important because it aims to find effective alternatives for patients who are struggling with their symptoms.

To participate in this study, individuals must be adults aged 18 to 65 years who have been diagnosed with acute severe ulcerative colitis and have not improved after receiving intravenous steroids. Participants can expect to receive either tofacitinib or cyclosporine as a new treatment option. It's important to know that individuals with certain health conditions, such as previous infections, specific heart risks, or ongoing treatments like infliximab, will not be eligible for this trial. The study is not yet recruiting participants, but it aims to provide valuable information to help manage this challenging condition.

Gender

ALL

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