Status:
COMPLETED
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe 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-alpha 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 :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
614 Patients enrolled
Trial Details
Trial ID
NCT01465763
Start Date
April 1 2012
End Date
May 1 2015
Last Update
June 7 2016
Active Locations (178)
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1
Internal Medicine Center, LLC
Mobile, Alabama, United States, 36608
2
Springhill Memorial Hospital
Mobile, Alabama, United States, 36608
3
Investigational Drug Service Pharmacy
La Jolla, California, United States, 92093
4
UCSD Medical Center
La Jolla, California, United States, 92093