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
Digestive Health Research Unit
Scottsdale, Arizona 85260
838
mi
from
Scottsdale, AZ
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
676
mi
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Birmingham, AL
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University of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
609
mi
from
Chicago, IL
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Clinical Research of West Florida
2147 Northeast Coachman Road
Clearwater, Florida 33765
1102
mi
from
Clearwater, FL
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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...
563
mi
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Houston, TX
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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...
618
mi
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Nashville, TN
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Omega Medical Research
400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
1420
mi
from
Warwick, RI
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Central Indiana Gastroenterology Group
Anderson, Indiana 46016
671
mi
from
Anderson, IN
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Saint John's Research Institute
Anderson, Indiana 46016
671
mi
from
Anderson, IN
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St. Joseph Mercy Hospital
Ann Arbor, Michigan 48197
810
mi
from
Ann Arbor, MI
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Digestive Disorders Associates
Annapolis, Maryland 21401
1155
mi
from
Annapolis, MD
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Disgestive Disorders Associates
Annapolis, Maryland 21401
1155
mi
from
Annapolis, MD
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Investigative Clinical Research
Annapolis, Maryland 21401
1155
mi
from
Annapolis, MD
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Maryland Diagnostics & Therapeutic Endo Center
Annapolis, Maryland 21401
1155
mi
from
Annapolis, MD
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Illinois Gastroenterology Group, LLC
Arlington Heights, Illinois 60005
599
mi
from
Arlington Heights, IL
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Professional Quality Research, Inc.
Austin, Texas 78705
517
mi
from
Austin, TX
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UAB Hospital
Birmingham, Alabama 35249
676
mi
from
Birmingham, AL
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Commonwealth Clinical Studies
Brockton, Massachusetts 02302
1445
mi
from
Brockton, MA
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The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
609
mi
from
Chicago, IL
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University of Chicago Medical Center
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
609
mi
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Chicago, IL
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University of Chicago Medical
Chicago, Illinois 60637
610
mi
from
Chicago, IL
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Concord Repatriation General Hospital
Concord, New South Wales
8653
mi
from
Concord,
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Gastroenterology Associates
Crystal River, Florida 34429
1068
mi
from
Crystal River, FL
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Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia 30033
805
mi
from
Decatur, GA
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Atlanta Endoscopy Center
Decatur, Georgia 30033
805
mi
from
Decatur, GA
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Decatur Health Imaging
Decatur, Georgia 30033
805
mi
from
Decatur, GA
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Rocky Mountain Clinical Research, LLC
Denver, Colorado 80229
410
mi
from
Denver, CO
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Pharma Resource
East Providence, Rhode Island 02915
1425
mi
from
East Providence, RI
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NorthShore University Health System
Evanston, Illinois 60201
612
mi
from
Evanston, IL
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Prima CARE
Fall River, Massachusetts 02720
1439
mi
from
Fall River, MA
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Gastro One
Germantown, Tennessee 38138
481
mi
from
Germantown, TN
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Glenbrook Hospital Outpatient Pharmacy
Glenview, Illinois 60025
607
mi
from
Glenview, IL
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Glenbrook Hospital
Glenview, Illinois 60026
606
mi
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Glenview, IL
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East Valley Endoscopy
Grand Rapids, Michigan 49546
739
mi
from
Grand Rapids, MI
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Endoscopy Center of Connecticut, LLC
Guilford, Connecticut 06437
1357
mi
from
Guilford, CT
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Endoscopy Center of Connecticut, LLC
Hamden, Connecticut 06518
1345
mi
from
Hamden, CT
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Gastroenterology Center of Connecticut
Hamden, Connecticut 06518
1345
mi
from
Hamden, CT
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
1345
mi
from
Hamden, CT
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Diagnostic Clinic of Houston
Houston, Texas 77003
569
mi
from
Houston, TX
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Houston Hospital for Specialized Surgery (Endoscopy only)
Houston, Texas 77030
569
mi
from
Houston, TX
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Baylor Clinic (Drug Storage)
Houston, Texas 77030
572
mi
from
Houston, TX
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Baylor College of Medicine - Baylor Medical Center
Houston, Texas 77030
572
mi
from
Houston, TX
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Ertan Digestive Disease Center
Houston, Texas 77030
569
mi
from
Houston, TX
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Memorial Hermann Hospital
Houston, Texas 77030
572
mi
from
Houston, TX
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University of Texas Medical School in Houston
Houston, Texas 77030
572
mi
from
Houston, TX
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Physicians Endoscopy Center (Colonoscopy)
Houston, Texas 77036
569
mi
from
Houston, TX
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Nature Coast Clinical Research
Inverness, Florida 34452
1084
mi
from
Inverness, FL
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Suncoast Endoscopy Center
Inverness, Florida 34453
1083
mi
from
Inverness, FL
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Rocky Mountain Gastroenterology Associates
Lakewood, Colorado 80215
415
mi
from
Lakewood, CO
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Rocky Mountain Gastroenterology
Lakewood, Colorado 80214
413
mi
from
Lakewood, CO
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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...
725
mi
from
Lexington, KY
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Arapahoe Gastroenterology
Littleton, Colorado 80120
408
mi
from
Littleton, CO
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University of Louisville Healthcare Outpatient Center
Louisville, Kentucky 40202
657
mi
from
Louisville, KY
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University of Louisville Research Foundation, Inc.
Louisville, Kentucky 40202
657
mi
from
Louisville, KY
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University of Louisville
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
656
mi
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Louisville, KY
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Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
788
mi
from
Marietta, GA
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GI Diagnostics
Marietta, Georgia 30067
792
mi
from
Marietta, GA
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Advanced Research Institute, Inc
New Port Richey, Florida
1096
mi
from
New Port Richey, FL
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Weill Cornell Medical College of Cornell University-Greenberg
New York, New York 10065
1289
mi
from
New York, NY
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Weill Cornell Medical College of Cornell University
New York, New York 10021
1289
mi
from
New York, NY
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Present, Chapman, Steinlauf and Marion
New York, New York 10028
1289
mi
from
New York, NY
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Mount Sinai School of Medicine
New York, New York 10029
1290
mi
from
New York, NY
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New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
New York, New York 10065
1289
mi
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New York, NY
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New York-Presbyterian Hospital
New York, New York 10032
1290
mi
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New York, NY
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Weill Cornell Imaging at New York Presbyterian Hospital
New York, New York 10065
1225
mi
from
New York, NY
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Arthur Asher Kornbluth
New York, New York 10128
1225
mi
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New York, NY
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Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma 73104
158
mi
from
Oklahoma City, OK
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Pharmacy: Wheeler and Stuckey, Inc.
Oklahoma City, Oklahoma 73103
157
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Oklahoma City, OK
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Colonoscopy and X-rays: OU Physicians Building
Oklahoma City, Oklahoma 73104
158
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Oklahoma City, OK
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Pittsburgh Gastroenterology Associates
Pittsburgh, Pennsylvania 15241
971
mi
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Pittsburgh, PA
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Research Protocol Management Specialists
Pittsburgh, Pennsylvania 15243
967
mi
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Pittsburgh, PA
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Minnesota Gastroenterology, P.A.
Plymouth, Minnesota 55446
551
mi
from
Plymouth, MN
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VCU Medical Investigational Drug Service (IDS)
Richmond, Virginia 93298
1111
mi
from
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...
1113
mi
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Richmond, VA
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University of Utah HSC
Salt Lake City, Utah 84132
777
mi
from
Salt Lake City, UT
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UCSF Endoscopy Unit at Mount Zion
San Francisco, California 94115
1340
mi
from
San Francisco, CA
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University of California at San Francisco
San Francisco, California 94143
1341
mi
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San Francisco, CA
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University of California, San Francisco - Mount Zion
San Francisco, California 94115
?
mi
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San Francisco, CA
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International Clinical Research - US, LLC
Sanford, Florida 32771
1134
mi
from
Sanford, FL
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Simon Medical Imaging
Scottsdale, Arizona 85258
842
mi
from
Scottsdale, AZ
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Texas Digestive Disease Consultants
Southlake, Texas 76092
334
mi
from
Southlake, TX
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One Step Diagnostic (X-Ray)
Sugar Land, Texas 77478
575
mi
from
Sugar Land, TX
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Pioneer Research Solutions, Inc. (Admin. Office)
Sugar Land, Texas 77479
575
mi
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Sugar Land, TX
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Pioneer Research Solutions , Inc
Sugarland, Texas 77479
575
mi
from
Sugarland, TX
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Adobe Clinical Research, LLC
Tucson, Arizona 85712
830
mi
from
Tucson, AZ
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Radiology Ltd
Tucson, Arizona 85712
833
mi
from
Tucson, AZ
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Hillcrest Medical Center Endoscopy
Tulsa, Oklahoma 74104
151
mi
from
Tulsa, OK
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Hillcrest Medical Center
Tulsa, Oklahoma 74101
149
mi
from
Tulsa, OK
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Options Health Research
Tulsa, Oklahoma 74137
158
mi
from
Tulsa, OK
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Utica Park Clinic X-Ray
Tulsa, Oklahoma 74104
151
mi
from
Tulsa, OK
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Advanced Imaging
Tulsa, Oklahoma 74137
149
mi
from
Tulsa, OK
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Digestive Health Specialists of Tyler
Tyler, Texas 75701
401
mi
from
Tyler, TX
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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...
976
mi
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Winston-Salem, NC
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Gastroenterology Associates of Western Michigan
Wyoming, Michigan 49519
730
mi
from
Wyoming, MI
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Metro Health Hospital Endoscopy Unit
Wyoming, Michigan 49519
728
mi
from
Wyoming, MI
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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
730
mi
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Wyoming, MI
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Huron Gastroenterology Associates
Ypsilanti, Michigan 48197
812
mi
from
Ypsilanti, MI
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St Joseph Mercy Hospital
Ypsilanti, Michigan 48197
812
mi
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Ypsilanti, MI
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