A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:February 2011
End Date:February 2015

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Trial Summary
Trial Overview
Inclusion Criteria

A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)

This is a proof of concept study to determine the efficacy and safety of a monoclonal
antibody with three doses versus placebo. Subjects will be randomized to a treatment and the
dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate
to severe refractory Crohn's Disease.


Inclusion Criteria:

- Subjects must have failed or are intolerant to anti TNFs

- hsCRP greater or equal to 5.0 mg/L

- Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed
within 8 weeks of study entry (screening) and able to retrospectively complete the
SES-CD or colonoscopy performed during screening

Exclusion Criteria:

- Pregnant or breastfeeding women

- Crohn's Disease with active fistulae or abscess

- History of diverticulitis or symptomatic diverticulosis

- Abnormality in hematology or chemistry profiles at screening
We found this trial at
98
sites
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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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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University of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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Clinical Research of West Florida
2147 Northeast Coachman Road
Clearwater, Florida 33765
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Omega Medical Research
400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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Warwick, RI
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Central Indiana Gastroenterology Group
Anderson, Indiana 46016
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Anderson, IN
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Saint John's Research Institute
Anderson, Indiana 46016
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St. Joseph Mercy Hospital
Ann Arbor, Michigan 48197
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Digestive Disorders Associates
Annapolis, Maryland 21401
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Disgestive Disorders Associates
Annapolis, Maryland 21401
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Investigative Clinical Research
Annapolis, Maryland 21401
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Maryland Diagnostics & Therapeutic Endo Center
Annapolis, Maryland 21401
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Illinois Gastroenterology Group, LLC
Arlington Heights, Illinois 60005
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Professional Quality Research, Inc.
Austin, Texas 78705
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UAB Hospital
Birmingham, Alabama 35249
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Commonwealth Clinical Studies
Brockton, Massachusetts 02302
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The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
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University of Chicago Medical Center
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
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University of Chicago Medical
Chicago, Illinois 60637
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Concord Repatriation General Hospital
Concord, New South Wales
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Gastroenterology Associates
Crystal River, Florida 34429
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Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia 30033
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Decatur, GA
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Atlanta Endoscopy Center
Decatur, Georgia 30033
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Decatur Health Imaging
Decatur, Georgia 30033
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Decatur, GA
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Rocky Mountain Clinical Research, LLC
Denver, Colorado 80229
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Pharma Resource
East Providence, Rhode Island 02915
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NorthShore University Health System
Evanston, Illinois 60201
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Prima CARE
Fall River, Massachusetts 02720
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Gastro One
Germantown, Tennessee 38138
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Glenbrook Hospital Outpatient Pharmacy
Glenview, Illinois 60025
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Glenbrook Hospital
Glenview, Illinois 60026
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East Valley Endoscopy
Grand Rapids, Michigan 49546
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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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Gastroenterology Center of Connecticut
Hamden, Connecticut 06518
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
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Diagnostic Clinic of Houston
Houston, Texas 77003
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Houston Hospital for Specialized Surgery (Endoscopy only)
Houston, Texas 77030
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Baylor Clinic (Drug Storage)
Houston, Texas 77030
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Baylor College of Medicine - Baylor Medical Center
Houston, Texas 77030
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Ertan Digestive Disease Center
Houston, Texas 77030
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Memorial Hermann Hospital
Houston, Texas 77030
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University of Texas Medical School in Houston
Houston, Texas 77030
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Physicians Endoscopy Center (Colonoscopy)
Houston, Texas 77036
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Nature Coast Clinical Research
Inverness, Florida 34452
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Suncoast Endoscopy Center
Inverness, Florida 34453
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Rocky Mountain Gastroenterology Associates
Lakewood, Colorado 80215
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Rocky Mountain Gastroenterology
Lakewood, Colorado 80214
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University of Kentucky
Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Arapahoe Gastroenterology
Littleton, Colorado 80120
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University of Louisville Healthcare Outpatient Center
Louisville, Kentucky 40202
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University of Louisville Research Foundation, Inc.
Louisville, Kentucky 40202
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University of Louisville
500 S Preston St
Louisville, Kentucky
(502) 852-5555
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Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
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Marietta, GA
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GI Diagnostics
Marietta, Georgia 30067
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Advanced Research Institute, Inc
New Port Richey, Florida
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Weill Cornell Medical College of Cornell University-Greenberg
New York, New York 10065
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Weill Cornell Medical College of Cornell University
New York, New York 10021
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Present, Chapman, Steinlauf and Marion
New York, New York 10028
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Mount Sinai School of Medicine
New York, New York 10029
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New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
New York, New York 10065
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New York-Presbyterian Hospital
New York, New York 10032
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Weill Cornell Imaging at New York Presbyterian Hospital
New York, New York 10065
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Arthur Asher Kornbluth
New York, New York 10128
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Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Pharmacy: Wheeler and Stuckey, Inc.
Oklahoma City, Oklahoma 73103
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Colonoscopy and X-rays: OU Physicians Building
Oklahoma City, Oklahoma 73104
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Pittsburgh Gastroenterology Associates
Pittsburgh, Pennsylvania 15241
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Research Protocol Management Specialists
Pittsburgh, Pennsylvania 15243
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Minnesota Gastroenterology, P.A.
Plymouth, Minnesota 55446
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VCU Medical Investigational Drug Service (IDS)
Richmond, Virginia 93298
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Virginia Commonwealth University
Richmond, Virginia 23298
(804) 828-0100
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University of Utah HSC
Salt Lake City, Utah 84132
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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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University of California, San Francisco - Mount Zion
San Francisco, California 94115
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International Clinical Research - US, LLC
Sanford, Florida 32771
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Sanford, FL
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Simon Medical Imaging
Scottsdale, Arizona 85258
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Scottsdale, AZ
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Digestive Health Research Unit
Scottsdale, Arizona 85260
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Texas Digestive Disease Consultants
Southlake, Texas 76092
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Southlake, TX
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One Step Diagnostic (X-Ray)
Sugar Land, Texas 77478
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Sugar Land, TX
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Pioneer Research Solutions, Inc. (Admin. Office)
Sugar Land, Texas 77479
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Pioneer Research Solutions , Inc
Sugarland, Texas 77479
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Adobe Clinical Research, LLC
Tucson, Arizona 85712
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Radiology Ltd
Tucson, Arizona 85712
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Hillcrest Medical Center Endoscopy
Tulsa, Oklahoma 74104
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Tulsa, OK
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Hillcrest Medical Center
Tulsa, Oklahoma 74101
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Options Health Research
Tulsa, Oklahoma 74137
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Utica Park Clinic X-Ray
Tulsa, Oklahoma 74104
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Advanced Imaging
Tulsa, Oklahoma 74137
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Digestive Health Specialists of Tyler
Tyler, Texas 75701
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PMG Research of Winston-Salem
1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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Gastroenterology Associates of Western Michigan
Wyoming, Michigan 49519
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Metro Health Hospital Endoscopy Unit
Wyoming, Michigan 49519
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Metro Health Hospital
5900 Byron Center Ave SW
Wyoming, Michigan 49519
(616) 252-7200
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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Huron Gastroenterology Associates
Ypsilanti, Michigan 48197
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St Joseph Mercy Hospital
Ypsilanti, Michigan 48197
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