A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe 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

NCT01465763

Run by

Pfizer

People needed

614

Starts

2012-04-01

Expected to finish

2015-05-01

Last updated by the study team

2016-06-07

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-alpha 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

• Springhill Memorial Hospital — Mobile, Alabama, United States
• Investigational Drug Service Pharmacy — La Jolla, California, United States
• UCSD Medical Center — La Jolla, California, United States
• UCSD Medical Centre — La Jolla, California, United States
• Cedars Sinai Medical Center - Thalians Bldg — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Cedars Sinai Surgery Center — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center — Los Angeles, California, United States
• Desert Advanced Imaging — Palm Springs, California, United States
• Erik Palmer, DO — Palm Springs, California, United States
• Homan A Zadeh, MD, MPH — Palm Springs, California, United States
• Hope Square Surgical Center — Rancho Mirage, California, United States
• Sharp Rees-Stealy Medical Group, Inc. — San Diego, California, United States
• Sharp Rees-Stealy Medical Group — San Diego, California, United States
• Sharp Rees-Stealy Medical Group,Inc — San Diego, California, United States
• Endoscopy Center of Connecticut, LLC — Guilford, Connecticut, United States
• Endoscopy Center of Connecticut, LLC — Hamden, Connecticut, United States
• Gastroenterology Center of Connecticut, PC — Hamden, Connecticut, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• Florida Surgery Center — Altamonte Springs, Florida, United States
• Center for Advanced Gastroenterology — Maitland, Florida, United States
• MNH Surgical Center — Maitland, Florida, United States
• Sand Lake Imaging — Maitland, Florida, United States
• Internal Medicine Center, LLC — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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