A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Tofacitinib

Criteria

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:

• Corticosteroids (oral or intravenous).

• Azathioprine or 6 mercaptopurine (6 MP).

• Anti TNF-alpha therapy.

Exclusion Criteria:

• Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.

• Subjects with disease limited to distal 15 cm.

• Subjects without previous treatment for UC (ie, treatment naïve).

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