Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Uma Mahadevan

Description

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.

Official Title

A Multi-center, Open-label Study Of Cp-690,550 In Subjects With Moderate To Severe Ulcerative Colitis

Keywords

Ulcerative Colitis open-label long term treatment Colitis Ulcer Colitis, Ulcerative Tofacitinib CP-690,550 CP-690,550 5 mg BID CP-690,550 10 mg BID

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSF Endoscopy Unit at Mount Zion
    San Francisco California 94115 United States
  • UCSF/Medical Center at Mount Zion
    San Francisco California 94115 United States
  • University of California San Francisco
    San Francisco California 94115 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT01470612
Phase
Phase 3
Lead Scientist
Uma Mahadevan
Study Type
Interventional
Last Updated
July 16, 2018