Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative Colitis



Status:Active, not recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:2/17/2019
Start Date:March 27, 2014
End Date:November 15, 2019

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A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

To evaluate safety and efficacy of two dosing regimens in achieving clinical remission in
subjects with moderately to severely active Ulcerative Colitis.


Inclusion Criteria:

- Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy
during Screening period.

- Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite
concurrent or prior treatment with a full and adequate course, in the opinion of the
Investigator, with oral corticosteroids or immunosuppressants or both.

Exclusion Criteria:

- Subject with Crohn's disease (CD) or indeterminate colitis (IC).

- Current diagnosis of fulminant colitis and/or toxic megacolon.

- Subjects with disease limited to the rectum (ulcerative proctitis) during the
screening endoscopy.

- Chronic recurring infections or active Tuberculosis (TB).
We found this trial at
44
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Shreveport, Louisiana 71061
1820
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Shreveport, LA
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Ann Arbor, MI
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5671 Peachtree Dunwoody Road
Atlanta, Georgia 30342
2174
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Atlanta, GA
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Austin, TX
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Baltimore, Maryland 21201
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Baltimore, MD
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Charlotte, North Carolina 28207
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Charlotte, NC
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Chattanooga, Tennessee 37403
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Chattanooga, TN
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Chevy Chase, MD
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Chicago, Illinois 60637
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Chicago, IL
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Chicago, IL
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Christiansburg, Virginia 24073
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Christiansburg, VA
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Cincinnati, OH
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Clearwater, Florida 33756
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Clearwater, FL
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480 Honeysuckle Road
Dothan, Alabama 36305
2242
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Dothan, AL
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Englewood, OH
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Gainesville, Florida 32605
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Gainesville, FL
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Garland, TX
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1324 Wolf Park Drive
Germantown, Tennessee 38138
1876
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Germantown, TN
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Great Neck, New York 11021
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Great Neck, NY
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Hamden, Connecticut 06518
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Hamden, CT
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Houston, TX
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La Jolla, California 92037
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La Jolla, CA
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Macon, GA
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Mexico, MO
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Miami, FL
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Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Milwaukee, Wisconsin 53226
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Milwaukee, WI
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1064 Goodlette-Frank Road
Naples, Florida 34102
2642
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Naples, FL
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1211 Medical Center Drive
Nashville, Tennessee 37212
1971
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Nashville, TN
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New York, NY
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5896 South Ridgeline Drive
Ogden, Utah 84405
680
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Ogden, UT
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Pittsburgh, Pennsylvania 15260
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Pittsburgh, PA
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Portland, OR
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3100 Duraleigh Road
Raleigh, North Carolina 27612
2357
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Raleigh, NC
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Rochester, Minnesota 55905
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Rochester, MN
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Salt Lake City, Utah 84132
702
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Salt Lake City, UT
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Seattle, Washington 98109
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Seattle, WA
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Southlake, TX
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Southlake, TX
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Tulsa, Oklahoma 74135
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Tulsa, OK
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Urbana, Illinois 61801
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Urbana, IL
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Vienna,
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Wheat Ridge, Colorado 80033
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Wheat Ridge, CO
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Winter Park, Florida 32789
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Winter Park, FL
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