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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Trial Summary
Trial Overview
Inclusion Criteria

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.
We found this trial at
62
sites
Virginia Commonwealth University
Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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University of Texas Health Science Center at Houston
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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Advanced Medical Research Center
1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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University of Rochester
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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Texas Clinical Research Institiute
Arlington, Texas 76012
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Austin Gastroenterology, PA
Austin, Texas 78705
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Austin Gastroenterology PA/Professional Quality Research, Inc.
Austin, Texas 78705
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Bristol Hospital
Bristol, Connecticut 06010
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Connecticut Clinical Research Foundation
Bristol, Connecticut 06010
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Clinical Research Institute of Michigan,
Chesterfield, Michigan 48098
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Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Chevy Chase Endoscopy Center (Endoscopies only)
Chevy Chase, Maryland 20815
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Surgery Center of Columbia
Columbia, Missouri 65201
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Citrus Surgery & Endoscopy Center (Colonoscopy)
Crystal River, Florida 34429
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Crystal River, FL
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Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia 30033
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Decatur, GA
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AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey 08234
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Egg Harbor Township, NJ
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Carolina Research - Carolina Digestive Diseases
Greenville, North Carolina 27834
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Hannibal Regional Hospital
Hannibal, Missouri 63401
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Memorial Hermann Hospital
Houston, Texas 77030
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Nature Coast Clinical Research
Inverness, Florida 34452
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Suncoast Endoscopy Center (colonoscopy)
Inverness, Florida 34453
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Regional Gastroenterology Associates of Lancaster, LTD
Lancaster, Pennsylvania 17604
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Lancaster, PA
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Dartmouth Hitchcock Medical Center
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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South Jersey Gastroenterology
Marlton, New Jersey 08053
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Audrain Medical Center
Mexico, Missouri 65265
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Mexico, MO
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Center for Digestive & Liver Disease, Inc.
Mexico, Missouri 65265
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Mexico, MO
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Gastroenterology Group of Naples
Naples, Florida 34102
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Naples, FL
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Vanderbilt University Medical Center - Drug Shipment
Nashville, Tennessee 37232
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Vanderbilt University Medical Center - GCRC
Nashville, Tennessee 37232
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Vanderbilt University Medical Center - GI Research Office
Nashville, Tennessee 37212
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Vanderbilt University Medical Center - Heart Station
Nashville, Tennessee 37232
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Vanderbilt University Medical Center - IBD Clinic
Nashville, Tennessee 37212
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Vanderbilt University Medical Center - Radiology
Nashville, Tennessee 37232
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Yale-New Haven Hospital
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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Yale University School of Medicine
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
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Alliance Clinical Research
Oceanside, California 92056
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Oceanside, CA
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Central Connecticut Endoscopy Center
Plainville, Connecticut 06062
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Plainville, CT
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Advanced Gastroenterology Center
Port Orange, Florida 32127
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Port Orange, FL
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Endoscopy Center
Port Orange, Florida 32127
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Port Orange Urgent Care
Port Orange, Florida 32127
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VCU Health System Digestive Health Center
Richmond, Virginia 23298
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Richmond, VA
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VCU Health System Endoscopy Suite
Richmond, Virginia 23298
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VCU Medical Center Investigational Drug Service (IDS)
Richmond, Virginia 23298
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The Mayo Clinic
Rochester, Minnesota 55905
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Clinical Application Laboratories, Inc.
San Diego, California 92103
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San Diego Endoscopy Center
San Diego, California 92103
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Medical Center at Mount Zion
San Francisco, California 94115
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UCSF Endoscopy Unit at Mount Zion
San Francisco, California 94115
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University of California at San Francisco
San Francisco, California 94143
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Gastrointestinal Specialists, A.M.C.
Shreveport, Louisiana 71103
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Louisiana Research Center, LLC
Shreveport, Louisiana 71103
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Shreveport Endoscopy Center, A.M.C.
Shreveport, Louisiana 71103
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Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas 66606
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Topeka, KS
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Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California 90502
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Center for Digestive Health
Troy, Michigan 48098
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Troy, MI
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Surgical Centers of Michigan
Troy, Michigan 48098
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Desert Sun Clinical Research, LCC
Tucson, Arizona 85710
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Desert Sun Gastroenterology
Tucson, Arizona 85710
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Desert Sun Surgery Center
Tucson, Arizona 85710
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Digestive Health Specialists of Tyler
Tyler, Texas 75701
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The Gastroenterology Group of South Jersey
Vineland, New Jersey 08360
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Vineland, NJ
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The Endo Center at Voorhees
Voorhees, New Jersey 08043
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