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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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-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.
We found this trial at
68
sites
East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems
Ann Arbor, Michigan 48109
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Cedars-Sinai Medical Center
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Gastroenterology Associates of Central Georgia
610 3rd St # 206
Macon, Georgia 31201
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Center for Advanced Gastroenterology
260 Lookout Pl # 201
Maitland, Florida 32751
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Internal Medicine Specialists
Orlando, Florida 32806
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Shafran Gastroenterology Center
701 West Morse Boulevard
Winter Park, Florida 32789
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Winter Park, FL
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Georgia Endoscopy Center (Colonoscopy only)
Alpharetta, Georgia 30005
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Florida Surgery Center
Altamonte Springs, Florida 32701
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Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)
Ann Arbor, Michigan 48106
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University of Michigan Health Systems
Ann Arbor, Michigan 48109
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Michigan Clinical Research Unit - Univeristy of Michigan Health System
Ann Arbor, Michigan 48109
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Medical Science Research Building 1 - University of Michigan Health Systems
Ann Arbor, Michigan 48109
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GI Consultants (Colonoscopy only)
Atlanta, Georgia 30342
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Atlanta, GA
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Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
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Camperdown,
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Clevland Clinic Department of Pharmacy
Cleveland, Ohio 44195
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Nyu Langone Long Island Clinical Research Associates
Great Neck, New York 11021
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NYU Langone Nassau Gastroenterology Associates
Great Neck, New York 11021
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Endoscopy Center of Connecticut, LLC
Guilford, Connecticut 06437
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Endoscopy Center of Connecticut, LLC
Hamden, Connecticut 06518
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Hamden, CT
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Gastroenterology Center of Connecticut
Hamden, Connecticut 06518
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
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Sunrise Medical Labs
Hicksville, New York 11801
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Baylor Medical Center
Houston, Texas 77030
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Gastroenterology Consultants
Houston, Texas 77034
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Houston Hospital for Specialized Surgery
Houston, Texas 77030
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Baylor College of Medicine - Baylor Medical Center (Drug Storage)
Houston, Texas 77030
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Emory Healthcare Heart Center (EKG)
Johns Creek, Georgia 30097
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Johns Creek, GA
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Investigational Drug Pharmacy, UCSD Health System, Moores Cancer Center
La Jolla, California 92037
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La Jolla, CA
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UCSD Medical Center
La Jolla, California 92093
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Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center
Los Angeles, California 90048
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CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center
Los Angeles, California 90048
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MD Office - Cedars-Sinai Medical Center Suite 203 E
Los Angeles, California 90048
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Regulatory Office - Cedars-Sinai Medical Center - Imflammatory Bowel Disease Center
Los Angeles, California 90048
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Cedars Sinai Medical Center - Thalians Bldg
Los Angeles, California 90048
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MNH Surgical Center
Maitland, Florida 32751
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Sand Lake Imaging
Maitland, Florida 32751
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Great Lakes Gastroenterology
Mentor, Ohio 44060
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Mentor, OH
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Center for Digestive Health
Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Wisconsin Center for Advanced Research - GI Associates, LLC
Milwaukee, Wisconsin 53215
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Horizon Research Group, Inc.
Mobile, Alabama 36608
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Mobile, AL
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Internal Medicine Center, LLC
Mobile, Alabama 36608
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Mobile, AL
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Springhill Memorial Hospital
Mobile, Alabama 36608
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Kornbluth, Legnani, George MD, PC
New York, New York 10128
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Mount Sinai Doctos Faculty Practice
New York, New York 10029
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Columbia University Medical Center
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Icahn School of Medicine at Mount Sinai
1428 Madison Ave
New York, New York 10029
(212) 241-6500
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The Private Practice of Simon Lichtiger, MD
New York, New York 10028
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CUMC Research Pharmacy
New York, New York 10032
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Southwest Gastroenterology
Oak Lawn, Illinois 60453
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North Florida Gastroenterology Research, LLC
Orange Park, Florida 32073
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Orange Park Surgery Center
Orange Park, Florida 32073
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Citrus Ambulatory Surgery Center
Orlando, Florida 32806
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Desert Advanced Imaging
Palm Springs, California 92262
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Erik Palmer, DO
Palm Springs, California 92262
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Homan A Zadeh, MD, MPH
Palm Springs, California 92262
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Hope Square Surgical Center
Rancho Mirage, California 92270
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Center for Advanced Medicine
Saint Louis, Missouri 63110
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Washington University School of Medicine - Division of Gastroenterology
Saint Louis, Missouri 63110
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Wasatch Clinical Research
Salt Lake City, Utah 84107
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Sharp Rees-Stealy Medical Group, Inc.
San Diego, California 92101
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Sharp Rees-Stealy Medical Group, Inc.
San Diego, California 92101
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Sharp Rees-Stealy
San Diego, California 92123
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Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia 30024
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Suwanee, GA
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Johns Creek Diagnostic Center (X-Ray only)
Suwanee, Georgia 30024
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Huron Gastroenterology Associates / Center for Digestive Care
Ypsilanti, Michigan 48197
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Ypsilanti, MI
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St. Joseph Mercy Health System Clinical Lab
Ypsilanti, Michigan 48197
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Michigan Heart SJMH
Ypsilanti, Michigan 48106
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Florida Medical Clinic
Zephyrhills, Florida 33542
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