ong-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis.
Phase 3
- Conditions
- Health Condition 1: null- Ulcerative Colitis
- Registration Number
- CTRI/2012/12/003257
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 725
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 Crohns 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety measured by the number of reported adverse eventsTimepoint: Time Frame: 12 Months
- Secondary Outcome Measures
Name Time Method umber of subjects with adjudicated cardiovascular events.Timepoint: Time Frame: 12 Months;Number of subjects with malignancies confirmed by central laboratory pathologist over read.Timepoint: Time Frame: 12 Months;Number of subjects with serious infectionsTimepoint: Time Frame: 12 Months;Proportion of subjects with addition of lipid lowering agents.Timepoint: Time Frame: 12 Months;The proportion of subjects in partial Mayo score remission.Timepoint: Time Frame: 12 Months;The proportion of subjects in remission.Timepoint: Time Frame: 12 Months;The proportion of subjects who achieve mucosal healing.Timepoint: Time Frame: 12 Months;The proportion of subjects with total score in Inflammatory Bowel Disease Questionnaire greater than or equal to 170.Timepoint: Time Frame: 12 Months