Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

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 Colitisopen-labellong term treatmentColitisUlcerColitis, UlcerativeTofacitinibCP-690,550CP-690,550 5 mg BIDCP-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

  • Perlman Medical Offices - UC San Diego Health System
    La JollaCalifornia92037United States
  • UCSD Medical Center
    La JollaCalifornia92093United States
  • Altman Clinical and Translational Research Institute
    La JollaCalifornia92037-0897United States
  • Investigational Drug Service Pharmacy
    La JollaCalifornia92037United States
  • Sharp Rees-Stealy Medical Group
    San DiegoCalifornia92123United States
  • Clinical Applications Laboratories, Inc
    San DiegoCalifornia92103United 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
Study Type
Interventional
Last Updated