Status:
COMPLETED
A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
Lead Sponsor:
Pfizer
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treat...
Eligibility Criteria
Inclusion
- Subject must be at least 18 years of age.
- Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
- Subjects with moderately to severely active UC based on Mayo score criteria.
- Subjects must have failed or be intolerant of at least one of the following treatments for UC:
- Corticosteroids (oral or intravenous).
- Azathioprine or 6 mercaptopurine (6 MP).
- Anti TNF therapy.
Exclusion
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
- Subjects with disease limited to distal 15 cm.
- Subjects without previous treatment for UC (ie, treatment naïve).
- Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
547 Patients enrolled
Trial Details
Trial ID
NCT01458951
Start Date
June 1 2012
End Date
June 1 2015
Last Update
June 1 2016
Active Locations (182)
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1
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States, 85710
2
Desert Sun Gastroenterology
Tucson, Arizona, United States, 85710
3
Desert Sun Surgery Center
Tucson, Arizona, United States, 85710
4
Alliance Clinical Research
Oceanside, California, United States, 92056