A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
Trial status: Open for Enrollment
Why is this study being done?
The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.
Who is eligible to participate?
- Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
- Subjects who achieved clinical response in Study A3921094 or A3921095
- Women of childbearing potential must test negative for pregnancy prior to study enrollment
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
- Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.