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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Edward Loftus, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Edward Loftus, M.D.

Closed for enrollment

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