A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis

• Status: Completed
• Trial end date: 2016-05-27
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: 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.