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Clinical Trials/CTRI/2023/11/059730
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
All India Institute of Medical Sciences New Delhi Delhi

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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