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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Trial Summary
Trial Overview
Inclusion Criteria

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
sites
Biopharma Informatic Research /ID# 171150
Houston, Texas 77084
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Houston, TX
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University of Michigan Hospitals /ID# 122240
Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Atlanta Gastro Assoc /ID# 122336
5671 Peachtree Dunwoody Road
Atlanta, Georgia 30342
1919
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Atlanta, GA
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Austin Center for Clinical Res /ID# 125396
Austin, Texas 78756
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Austin, TX
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University of Maryland Med Ctr /ID# 169734
Baltimore, Maryland 21201
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Baltimore, MD
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Charlotte Gastro Hepatology /ID# 122235
Charlotte, North Carolina 28207
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Charlotte, NC
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Erlanger Institute for Clinica /ID# 129009
Chattanooga, Tennessee 37403
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Chattanooga, TN
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MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238
Chevy Chase, Maryland 20815
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Chevy Chase, MD
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University of Chicago /ID# 122302
Chicago, Illinois 60637
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Chicago, IL
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Northwestern University Feinberg School of Medicine /ID# 122183
Chicago, Illinois 60611
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Chicago, IL
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New River Valley Research Inst /ID# 127801
Christiansburg, Virginia 24073
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Christiansburg, VA
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Consultants for Clinical Res /ID# 122304
Cincinnati, Ohio 45219
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Cincinnati, OH
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Gastro Florida /ID# 170619
Clearwater, Florida 33756
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Clearwater, FL
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Digestive Health Specialists of the Southeast /ID# 127844
480 Honeysuckle Road
Dothan, Alabama 36305
1897
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from 91732
Dothan, AL
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Dayton Gastroenterology, Inc. /ID# 127804
Englewood, Ohio 45415
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Englewood, OH
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Florida Research Network, LLC /ID# 170618
Gainesville, Florida 32605
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Gainesville, FL
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DHAT Research Institute /ID# 170616
Garland, Texas 75044
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Garland, TX
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Gastro One /ID# 122339
1324 Wolf Park Drive
Germantown, Tennessee 38138
1600
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from 91732
Germantown, TN
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NYU Langone Long Island CRA /ID# 122177
Great Neck, New York 11021
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Great Neck, NY
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Medical Research Ctr CT /ID# 122179
Hamden, Connecticut 06518
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Hamden, CT
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Ucsd /Id# 122313
La Jolla, California 92037
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La Jolla, CA
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Gastro Assoc of Central GA /ID# 122318
Macon, Georgia 31201
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Macon, GA
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Ctr for Digest and Liver Dis /ID# 122182
Mexico, Missouri 65265
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Mexico, MO
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Research Associates of South Florida,LLC /ID# 170309
Miami, Florida 33156
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Miami, FL
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WI Center for Advanced Res /ID# 122178
Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Froedtert and Medical College /ID# 122261
Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Gastroenterology Group of Naples /ID# 127806
1064 Goodlette-Frank Road
Naples, Florida 34102
2220
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Naples, FL
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Vanderbilt University Medical Center /ID# 125496
1211 Medical Center Drive
Nashville, Tennessee 37212
1762
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Nashville, TN
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Icahn School of Med Mt. Sinai /ID# 127047
New York, New York 10029
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New York, NY
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Advanced Research Institute /ID# 126147
5896 South Ridgeline Drive
Ogden, Utah 84405
591
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Ogden, UT
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University of Pittsburgh MC /ID# 122331
Pittsburgh, Pennsylvania 15260
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Pittsburgh, PA
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The Oregon Clinic- Gastro West /ID# 135273
Portland, Oregon 97225
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Portland, OR
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Wake Research Associates, LLC /ID# 122157
3100 Duraleigh Road
Raleigh, North Carolina 27612
2214
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Raleigh, NC
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Mayo Clinic - Rochester /ID# 122244
Rochester, Minnesota 55905
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Rochester, MN
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University of Utah /ID# 122333
Salt Lake City, Utah 84132
573
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Salt Lake City, UT
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University of Washington /ID# 169721
Seattle, Washington 98109
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Seattle, WA
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Louisiana Research Center, LLC /ID# 141655
Shreveport, Louisiana 71061
1401
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Shreveport, LA
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Texas Digestive Disease Consul /ID# 141677
Southlake, Texas 76092
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Southlake, TX
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Texas Digestive Disease Consul /ID# 141678
Southlake, Texas 76092
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Southlake, TX
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Gastro United of Tulsa /ID# 125436
Tulsa, Oklahoma 74135
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Tulsa, OK
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Carle Foundation Hospital /ID# 135955
Urbana, Illinois 61801
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Urbana, IL
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Medizinische Universität Wien /ID# 127186
Vienna, Wien
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Vienna,
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Rocky Mountain Clinical Resear /ID# 122180
Wheat Ridge, Colorado 80033
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Wheat Ridge, CO
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Shafran Gastroenterology Ctr /ID# 122320
Winter Park, Florida 32789
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Winter Park, FL
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