PHASE III Study to evaluate safety and efficacy OF Oral CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Phase 3

• Conditions: Health Condition 1: null- Ulcerative Colitis

• Registration Number: CTRI/2013/01/003328
• Lead Sponsor: Pfizer Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 545

Inclusion Criteria

Subject must be at least 18 years of age.

• Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.

• Subjects with moderately to severely active UC based on Mayo score criteria.

•Subjects must have failed or be intolerant of at least one of the following treatments for UC:

•Oral corticosteroids.

•Azathioprine or 6 mercaptopurine (6 MP).

•Anti TNF therapy.

Note: There is no upper age limit mentioned in the protocol

Exclusion Criteria

1. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns disease.

2. Subjects with disease limited to distal 15 cm.

3. Subjects without previous treatment for UC (i.e., treatment naïve).

4. Subjects displaying clinical signs of fulminant colitis or toxic megacolon.

Study & Design

• Study Type: Interventional
• Study Design: Not specified