A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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 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.

Last updated:

9/25/2014

NCT ID:

NCT01458951

IRB Number:

12-000546