Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
Purpose
This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.
Condition
- Ulcerative Colitis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subjects who completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR - Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure.
Exclusion Criteria
- Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096. - Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease. - Subjects who have had surgery for ulcerative colitis or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study period.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CP-690,550 5 mg BID |
5 mg BID |
|
|
Experimental CP-690,550 10 mg BID |
10 mg BID |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer