Overview

Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis

Status:
Completed

Trial end date:
2020-08-06

Target enrollment:
0

Participant gender:
All

Summary

This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Tofacitinib

Criteria

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 Crohn's 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.