Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease



Status:Active, not recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:2/20/2019
Start Date:April 9, 2014
End Date:February 3, 2020

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Trial Summary
Trial Overview
Inclusion Criteria

A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

This study will evaluate higher versus standard adalimumab dosing regimens for induction and
maintenance therapy in subjects with moderately to severely active Crohn's Disease and
evidence of mucosal ulceration.


Inclusion Criteria:

- Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during
the Screening Period.

- Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral
corticosteroids and/or immunosuppressants.

- Mucosal ulceration on endoscopy.

Exclusion Criteria:

- Subject with ulcerative colitis or indeterminate colitis.

- Subject who has had surgical bowel resections in the past 6 months or is planning
resection.

- Subjects with an ostomy or ileoanal pouch.

- Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.

- Subject who has short bowel syndrome.

- Chronic recurring infections or active Tuberculosis (TB).
We found this trial at
49
sites
Albany Medical College /ID# 140200
47 New Scotland Avenue
Albany, New York 12208
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University of Michigan Hospitals /ID# 119076
Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Digestive Disorders Associates /ID# 119033
621 Ridgely Avenue
Annapolis, Maryland 21401
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Annapolis, MD
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Emory University Hospital /ID# 136851
Atlanta, Georgia 30322
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Atlanta, GA
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Atlanta Gastro Assoc /ID# 119065
5671 Peachtree Dunwoody Road
Atlanta, Georgia 30342
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Atlanta, GA
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Austin Center for Clinical Res /ID# 125500
Austin, Texas 78756
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Austin, TX
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Birmingham Gastroenterology /ID# 137282
Birmingham, Alabama 35209
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Birmingham, AL
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Commonwealth Clinical Studies /ID# 136850
Brockton, Massachusetts 02302
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Brockton, MA
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Medical University of South Carolina /ID# 138122
96 Jonathan Lucas Street
Charleston, South Carolina 29425
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Charleston, SC
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Charlotte Gastro Hepatology /ID# 119041
Charlotte, North Carolina 28207
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Charlotte, NC
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Erlanger Institute for Clinica /ID# 129008
Chattanooga, Tennessee 37403
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Chattanooga, TN
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Gastro Assoc of Tidewater /ID# 135897
Chesapeake, Virginia 23320
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Chesapeake, VA
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MGG Group, Inc.Chevy Chase Clinical Research /ID# 119042
Chevy Chase, Maryland 20815
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Chevy Chase, MD
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University of Chicago /ID# 119077
Chicago, Illinois 60637
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Chicago, IL
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Northwestern University Feinberg School of Medicine /ID# 119043
Chicago, Illinois 60611
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Chicago, IL
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New River Valley Research Inst /ID# 127807
Christiansburg, Virginia 24073
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Christiansburg, VA
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Consultants for Clinical Res /ID# 119052
Cincinnati, Ohio 45219
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Cincinnati, OH
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TX Digestive Disease Consultan /ID# 138121
Dallas, Texas 75231
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Dallas, TX
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Digestive Health Specialists of the Southeast /ID# 122483
480 Honeysuckle Road
Dothan, Alabama 36305
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Dothan, AL
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Gastro One /ID# 119068
1324 Wolf Park Drive
Germantown, Tennessee 38138
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Germantown, TN
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NYU Langone Long Island CRA /ID# 119035
Great Neck, New York 11021
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Great Neck, NY
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Medical Research Ctr CT /ID# 119037
Hamden, Connecticut 06518
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Hamden, CT
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Baylor College of Medicine /ID# 137277
Houston, Texas 77030
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Houston, TX
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Kansas City Research Institute /ID# 119034
425 Volker Boulevard
Kansas City, Missouri 64131
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Kansas City, MO
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Ucsd /Id# 119053
9500 Gilman Dr
La Jolla, California 92093
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La Jolla, CA
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Axis Clinical Trials /ID# 130390
5800 Wilshire Boulevard
Los Angeles, California 90036
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Los Angeles, CA
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Gastro Assoc of Central GA /ID# 119056
Macon, Georgia 31201
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Macon, GA
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Ctr for Digest and Liver Dis /ID# 119040
Mexico, Missouri 65265
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Mexico, MO
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WI Center for Advanced Res /ID# 119036
Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Froedtert and Medical College /ID# 119081
Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Gastroenterology Group of Naples /ID# 122493
1064 Goodlette-Frank Road
Naples, Florida 34102
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Naples, FL
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Nashville Med Res Inst /ID# 119050
Nashville, Tennessee 37205
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Nashville, TN
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Vanderbilt University Medical Center /ID# 125501
1211 Medical Center Drive
Nashville, Tennessee 37212
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Icahn School of Med Mt. Sinai /ID# 127116
New York, New York 10029
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New York, NY
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Advanced Research Institute /ID# 119048
5896 South Ridgeline Drive
Ogden, Utah 84405
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Ogden, UT
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Internal Med Specialists /ID# 137737
Orlando, Florida 32806
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Orlando, FL
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Minnesota Gastroenterology, P. A. /ID# 137280
Plymouth, Minnesota 55446
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Plymouth, MN
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The Oregon Clinic- Gastro West /ID# 135272
Portland, Oregon 97225
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Portland, OR
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Wake Research Associates, LLC /ID# 119029
3100 Duraleigh Road
Raleigh, North Carolina 27612
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Raleigh, NC
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Mayo Clinic - Rochester /ID# 122489
Rochester, Minnesota 55905
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Rochester, MN
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University of Utah /ID# 119062
Salt Lake City, Utah 84132
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Salt Lake City, UT
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Louisiana Research Center, LLC /ID# 136749
Shreveport, Louisiana 71061
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Shreveport, LA
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Texas Digestive Disease Consul /ID# 137283
Southlake, Texas 76092
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Southlake, TX
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Gastro United of Tulsa /ID# 122485
Tulsa, Oklahoma 74135
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Tulsa, OK
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Carle Cancer Center /ID# 136008
509 West University Avenue
Urbana, Illinois 61801
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Urbana, IL
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Medizinische Universität Wien /ID# 126279
Vienna, Wien
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Vienna,
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West Bay Clinical Research /ID# 138330
Warwick, Rhode Island 02886
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Warwick, RI
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Rocky Mountain Clinical Resear /ID# 119038
Wheat Ridge, Colorado 80033
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Wheat Ridge, CO
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Shafran Gastroenterology Ctr /ID# 119057
Winter Park, Florida 32789
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Winter Park, FL
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