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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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
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47 New Scotland Avenue
Albany, New York 12208
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621 Ridgely Avenue
Annapolis, Maryland 21401
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Atlanta, Georgia 30322
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5671 Peachtree Dunwoody Road
Atlanta, Georgia 30342
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Austin, TX
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Birmingham, Alabama 35209
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Brockton, Massachusetts 02302
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
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Charlotte, North Carolina 28207
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Chattanooga, Tennessee 37403
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Chesapeake, Virginia 23320
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Chevy Chase, MD
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Chicago, Illinois 60637
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Christiansburg, Virginia 24073
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Cincinnati, OH
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480 Honeysuckle Road
Dothan, Alabama 36305
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1324 Wolf Park Drive
Germantown, Tennessee 38138
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Great Neck, New York 11021
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Hamden, Connecticut 06518
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425 Volker Boulevard
Kansas City, Missouri 64131
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9500 Gilman Dr
La Jolla, California 92093
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5800 Wilshire Boulevard
Los Angeles, California 90036
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Macon, GA
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Milwaukee, Wisconsin 53215
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Milwaukee, Wisconsin 53226
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1064 Goodlette-Frank Road
Naples, Florida 34102
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Nashville, Tennessee 37205
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1211 Medical Center Drive
Nashville, Tennessee 37212
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5896 South Ridgeline Drive
Ogden, Utah 84405
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Orlando, Florida 32806
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3100 Duraleigh Road
Raleigh, North Carolina 27612
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Rochester, Minnesota 55905
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Salt Lake City, Utah 84132
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Shreveport, Louisiana 71061
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Tulsa, Oklahoma 74135
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509 West University Avenue
Urbana, Illinois 61801
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Warwick, Rhode Island 02886
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Wheat Ridge, Colorado 80033
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Winter Park, Florida 32789
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