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



Status:Completed
Conditions:Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2012
End Date:May 2015

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A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis

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.


Inclusion Criteria:

- 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 Criteria:

- 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.
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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610 3rd St # 206
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630 W 168th St
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1428 Madison Ave
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