Overview
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
Status:
Completed
Completed
Trial end date:
2016-05-27
2016-05-27
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
PfizerTreatments:
Tofacitinib
Criteria
Inclusion Criteria:- 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.
Exclusion Criteria:
- 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.