Status:
COMPLETED
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
Lead Sponsor:
Pfizer
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2020
Estimated Enrollment :
944 Patients enrolled
Trial Details
Trial ID
NCT01470612
Start Date
October 1 2012
End Date
August 6 2020
Last Update
September 17 2021
Active Locations (252)
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1
Alabama Medical Group, P.C.
Mobile, Alabama, United States, 36608
2
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States, 85710
3
Desert Sun Gastroenterology
Tucson, Arizona, United States, 85710
4
Desert Sun Surgery Center
Tucson, Arizona, United States, 85710