CTRI/2023/11/059730
Not yet recruiting
Phase 3
A Randomized Controlled Trial Comparing the Time to Achieve ClinicalResponse in Patients with Moderate to Severe Ulcerative Colitis UsingCorticosteroids versus Tofacitinib. - NA
All India Institute of Medical Sciences New Delhi Delhi0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- All India Institute of Medical Sciences New Delhi Delhi
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with moderate to severe (as defined
- •by SCCAI score \>6 and UCEIS \>3\)
- •2\. Patients who are on optimum dosage of oral
- •(minimum 2\.4 g per day) and topical 5\-ASA
- •agents, are steroid naïve, or steroid
- •experienced (last dose \>12 weeks prior) but
- •not on steroids or azathioprine.
- •3\. Anti\-TNF/Anti\-integrin naïve or
- •experienced (intolerant or non\-responder)
- •but last dose \=2 months back.
Exclusion Criteria
- •1\) Age \<18 years, \>65 years
- •2\) Patients with acute severe ulcerative colitis
- •3\) Clinical signs of fulminant colitis or toxic
- •4\) Patients with a steroid refractory disease.
- •5\) Indeterminate, ischemic, infectious or
- •Crohn’s colitis
- •6\) Received no treatment for UC in past i.e.,
- •treatment\-naïve
- •7\) If the subject has received the following
- •therapya. Intravenous corticosteroids within 2
Outcomes
Primary Outcomes
Not specified
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