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



Status:Completed
Conditions:Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2012
End Date:June 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 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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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Arlington, Texas 76012
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Austin, Texas 78705
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Bristol, Connecticut 06010
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Chesterfield, Michigan 48098
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Columbia, Missouri 65201
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Decatur, GA
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Egg Harbor Township, New Jersey 08234
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Greenville, North Carolina 27834
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Hannibal, Missouri 63401
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Houston, Texas 77030
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Inverness, Florida 34452
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Lancaster, PA
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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Marlton, New Jersey 08053
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Mexico, Missouri 65265
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Naples, Florida 34102
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Nashville, Tennessee 37232
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20 York St, N20 York St,
New Haven, Connecticut 06520
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Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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333 Cedar St
New Haven, Connecticut 06504
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Oceanside, California 92056
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Port Orange, Florida 32127
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Richmond, Virginia 23298
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Rochester, Minnesota 55905
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San Diego, California 92103
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