A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:11/8/2017
Start Date:March 17, 2015
End Date:August 4, 2017

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To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately
to severely active Crohn's Disease with a history of inadequate response to or intolerance to
Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.


Inclusion Criteria:

1. Diagnosis of Crohn's disease (CD) for at least 90 days.

2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or
equal to 450.

3. Subject inadequately responded to or experience intolerance to previous treatment with
immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or
anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).

Exclusion Criteria:

1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.

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

3. Subjects with an ostomy or ileoanal pouch.

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

5. Subject who has short bowel syndrome.

6. Subject with recurring infections or active Tuberculosis (TB).
We found this trial at
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Gainesville, Florida 32608
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354
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Annapolis, MD
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2350 Prince Avenue
Athens, Georgia 30606
414
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Athens, GA
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325 Pittsboro Street
Chapel Hill, North Carolina 27599
354
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Chapel Hill, NC
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
524
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Charleston, SC
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2015 Randolph Road
Charlotte, North Carolina 28207
350
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Charlotte, NC
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1221 Lee Street
Charlottesville, Virginia 22908
277
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Charlottesville, VA
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Chevy Chase, Maryland 20815
324
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Chevy Chase, MD
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2925 Vernon Place
Cincinnati, Ohio 45219
97
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3230 Eden Avenue
Cincinnati, Ohio 45267
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Cincinnati, OH
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9462
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Concord,
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6800 Northwest 9th Boulevard
Gainesville, Florida 32605
712
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1324 Wolf Park Drive
Germantown, Tennessee 38138
500
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Germantown, TN
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1000 Northern Boulevard
Great Neck, New York 11021
493
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Great Neck, NY
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200 Patewood Drive
Greenville, South Carolina 29615
355
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Greenville, SC
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1150 North 35th Avenue
Hollywood, Florida 33021
977
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Hollywood, FL
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995
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Houston, TX
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411 West Highland Boulevard
Inverness, Florida 34452
770
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884 Lakeland Drive
Jackson, Mississippi 39216
660
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425 Volker Boulevard
Kansas City, Missouri 64131
619
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9500 Gilman Drive
La Jolla, California 92093
1951
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Limerick, Pennsylvania 19468
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401 East Chestnut Street
Louisville, Kentucky 40202
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493
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Macon, GA
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260 Lookout Place
Maitland, Florida 32751
788
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711 Canton Road
Marietta, Georgia 30060
422
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Marietta, GA
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Miami, Florida 33136
996
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3201 South 16th Street
Milwaukee, Wisconsin 53215
328
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1064 Goodlette-Frank Road
Naples, Florida 34102
956
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480
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New York, NY
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1140 West La Veta Avenue
Orange, California 92868
1959
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1215 South 1680 West
Orem, Utah 84058
1510
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3885 Oakwater Circle
Orlando, Florida 32806
797
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15700 37th Avenue North
Plymouth, Minnesota 55446
636
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3 Riverside Circle
Roanoke, Virginia 24016
250
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200 1st Street Southwest
Rochester, Minnesota 55905
559
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660 South Euclid Avenue
Saint Louis, Missouri 63110
397
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505 Parnassus Avenue
San Francisco, California 94143
2109
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Seattle, Washington 98195
2005
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2751 Albert L Bicknell Drive
Shreveport, Louisiana 71103
790
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1800 East 70th Street
Shreveport, Louisiana 71105
789
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920
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Southlake, TX
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3520 Southwest 6th Avenue
Topeka, Kansas 66606
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7801 York Road
Towson, Maryland 21204
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4600 Investment Drive
Troy, Michigan 48098
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Troy, MI
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751
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Tulsa, OK
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509 West University Avenue
Urbana, Illinois 61801
274
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2645 North Mayfair Road
Wauwatosa, Wisconsin 53226
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7760 West 38th Avenue
Wheat Ridge, Colorado 80033
1166
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306
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Winston-Salem, NC
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701 West Morse Boulevard
Winter Park, Florida 32789
791
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