A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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 treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

Key facts

Study ID

NCT01458951

Run by

Pfizer

People needed

547

Starts

2012-06-01

Expected to finish

2015-06-01

Last updated by the study team

2016-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Desert Sun Gastroenterology — Tucson, Arizona, United States
• Desert Sun Surgery Center — Tucson, Arizona, United States
• Alliance Clinical Research — Oceanside, California, United States
• Clinical Application Laboratories — San Diego, California, United States
• San Diego Endoscopy Center — San Diego, California, United States
• UCSF Endoscopy Unit at Mount Zion — San Francisco, California, United States
• University of California San Francisco — San Francisco, California, United States
• Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center — Torrance, California, United States
• Bristol Hospital — Bristol, Connecticut, United States
• Connecticut Clinical Research Foundation — Bristol, Connecticut, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Central Connecticut Endoscopy Center — Plainville, Connecticut, United States
• Citrus Surgery & Endoscopy Center (Colonoscopy) — Crystal River, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• Suncoast Endoscopy Center (colonoscopy) — Inverness, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Advanced Gastroenterology Center — Port Orange, Florida, United States
• Advanced Medical Research Center — Port Orange, Florida, United States
• Endoscopy Center — Port Orange, Florida, United States
• Port Orange Urgent Care — Port Orange, Florida, United States
• Atlanta Center for Gastroenterology, P.C. — Decatur, Georgia, United States
• Cotton-O'Neil Clinical Research Center, Digestive Health — Topeka, Kansas, United States
• Gastrointestinal Specialists, A.M.C. — Shreveport, Louisiana, United States
• Desert Sun Clinical Research, LLC — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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