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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Patients must be at least 18 years of age at screening

• Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to entry into the study.

• Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of ≥6

• Patients with endoscopic sub-score of ≥2 on the Mayo score determined within 7 days of baseline.

Exclusion Criteria:

• Diagnosis of Crohn's disease or diagnosis of indeterminate colitis

• Treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis

• Patients that are currently receiving immunosuppressants, anti-TNFα therapy or interferon