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
Research Protocol Management Specialists
Pittsburgh, Pennsylvania 15243
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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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University of Texas Health Science Center at Houston
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
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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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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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Atlanta Endoscopy Center
Decatur, Georgia 30033
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Decatur Health Imaging
Decatur, Georgia 30033
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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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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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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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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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Simon Medical Imaging
Scottsdale, Arizona 85258
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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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One Step Diagnostic (X-Ray)
Sugar Land, Texas 77478
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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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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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