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
VCU Health System Endoscopy Suite
Richmond, Virginia 23298
344
mi
from 43215
Richmond, VA
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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...
990
mi
from 43215
Houston, TX
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Advanced Medical Research Center
1690 Dunlawton Ave # 220
Port Orange, Florida 32127
758
mi
from 43215
Port Orange, FL
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University of Rochester
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....
354
mi
from 43215
Rochester, NY
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Texas Clinical Research Institiute
Arlington, Texas 76012
928
mi
from 43215
Arlington, TX
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Austin Gastroenterology, PA
Austin, Texas 78705
1064
mi
from 43215
Austin, TX
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Austin Gastroenterology PA/Professional Quality Research, Inc.
Austin, Texas 78705
1065
mi
from 43215
Austin, TX
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Bristol Hospital
Bristol, Connecticut 06010
540
mi
from 43215
Bristol, CT
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Connecticut Clinical Research Foundation
Bristol, Connecticut 06010
539
mi
from 43215
Bristol, CT
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Clinical Research Institute of Michigan,
Chesterfield, Michigan 48098
182
mi
from 43215
Chesterfield, MI
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Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
324
mi
from 43215
Chevy Chase, MD
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Chevy Chase Endoscopy Center (Endoscopies only)
Chevy Chase, Maryland 20815
324
mi
from 43215
Chevy Chase, MD
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Surgery Center of Columbia
Columbia, Missouri 65201
501
mi
from 43215
Columbia, MO
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Citrus Surgery & Endoscopy Center (Colonoscopy)
Crystal River, Florida 34429
764
mi
from 43215
Crystal River, FL
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Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia 30033
430
mi
from 43215
Decatur, GA
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AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey 08234
450
mi
from 43215
Egg Harbor Township, NJ
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Carolina Research - Carolina Digestive Diseases
Greenville, North Carolina 27834
430
mi
from 43215
Greenville, NC
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Hannibal Regional Hospital
Hannibal, Missouri 63401
447
mi
from 43215
Hannibal, MO
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Memorial Hermann Hospital
Houston, Texas 77030
995
mi
from 43215
Houston, TX
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Nature Coast Clinical Research
Inverness, Florida 34452
772
mi
from 43215
Inverness, FL
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Suncoast Endoscopy Center (colonoscopy)
Inverness, Florida 34453
769
mi
from 43215
Inverness, FL
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Regional Gastroenterology Associates of Lancaster, LTD
Lancaster, Pennsylvania 17604
354
mi
from 43215
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...
609
mi
from 43215
Lebanon, NH
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South Jersey Gastroenterology
Marlton, New Jersey 08053
429
mi
from 43215
Marlton, NJ
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Audrain Medical Center
Mexico, Missouri 65265
474
mi
from 43215
Mexico, MO
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Center for Digestive & Liver Disease, Inc.
Mexico, Missouri 65265
474
mi
from 43215
Mexico, MO
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Gastroenterology Group of Naples
Naples, Florida 34102
957
mi
from 43215
Naples, FL
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Vanderbilt University Medical Center - Drug Shipment
Nashville, Tennessee 37232
334
mi
from 43215
Nashville, TN
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Vanderbilt University Medical Center - GCRC
Nashville, Tennessee 37232
334
mi
from 43215
Nashville, TN
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Vanderbilt University Medical Center - GI Research Office
Nashville, Tennessee 37212
334
mi
from 43215
Nashville, TN
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Vanderbilt University Medical Center - Heart Station
Nashville, Tennessee 37232
334
mi
from 43215
Nashville, TN
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Vanderbilt University Medical Center - IBD Clinic
Nashville, Tennessee 37212
334
mi
from 43215
Nashville, TN
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Vanderbilt University Medical Center - Radiology
Nashville, Tennessee 37232
332
mi
from 43215
Nashville, TN
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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...
537
mi
from 43215
New Haven, CT
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Yale University School of Medicine
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
537
mi
from 43215
New Haven, CT
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Alliance Clinical Research
Oceanside, California 92056
1945
mi
from 43215
Oceanside, CA
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Central Connecticut Endoscopy Center
Plainville, Connecticut 06062
543
mi
from 43215
Plainville, CT
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Advanced Gastroenterology Center
Port Orange, Florida 32127
758
mi
from 43215
Port Orange, FL
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Endoscopy Center
Port Orange, Florida 32127
758
mi
from 43215
Port Orange, FL
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Port Orange Urgent Care
Port Orange, Florida 32127
758
mi
from 43215
Port Orange, FL
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VCU Health System Digestive Health Center
Richmond, Virginia 23298
344
mi
from 43215
Richmond, VA
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VCU Medical Center Investigational Drug Service (IDS)
Richmond, Virginia 23298
344
mi
from 43215
Richmond, VA
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Virginia Commonwealth University
Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
344
mi
from 43215
Richmond, VA
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The Mayo Clinic
Rochester, Minnesota 55905
559
mi
from 43215
Rochester, MN
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Clinical Application Laboratories, Inc.
San Diego, California 92103
1951
mi
from 43215
San Diego, CA
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San Diego Endoscopy Center
San Diego, California 92103
1951
mi
from 43215
San Diego, CA
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Medical Center at Mount Zion
San Francisco, California 94115
2108
mi
from 43215
San Francisco, CA
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UCSF Endoscopy Unit at Mount Zion
San Francisco, California 94115
2108
mi
from 43215
San Francisco, CA
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University of California at San Francisco
San Francisco, California 94143
2109
mi
from 43215
San Francisco, CA
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Gastrointestinal Specialists, A.M.C.
Shreveport, Louisiana 71103
789
mi
from 43215
Shreveport, LA
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Louisiana Research Center, LLC
Shreveport, Louisiana 71103
789
mi
from 43215
Shreveport, LA
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Shreveport Endoscopy Center, A.M.C.
Shreveport, Louisiana 71103
789
mi
from 43215
Shreveport, LA
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Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas 66606
676
mi
from 43215
Topeka, KS
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Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California 90502
1980
mi
from 43215
Torrance, CA
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Center for Digestive Health
Troy, Michigan 48098
182
mi
from 43215
Troy, MI
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Surgical Centers of Michigan
Troy, Michigan 48098
181
mi
from 43215
Troy, MI
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Desert Sun Clinical Research, LCC
Tucson, Arizona 85710
1633
mi
from 43215
Tucson, AZ
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Desert Sun Gastroenterology
Tucson, Arizona 85710
1634
mi
from 43215
Tucson, AZ
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Desert Sun Surgery Center
Tucson, Arizona 85710
1641
mi
from 43215
Tucson, AZ
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Digestive Health Specialists of Tyler
Tyler, Texas 75701
863
mi
from 43215
Tyler, TX
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The Gastroenterology Group of South Jersey
Vineland, New Jersey 08360
426
mi
from 43215
Vineland, NJ
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The Endo Center at Voorhees
Voorhees, New Jersey 08043
427
mi
from 43215
Voorhees, NJ
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