AMG 827 in Subjects With Moderate to Severe Crohn's Disease



Status:Terminated
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:July 2010
End Date:August 2011

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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn's Disease

The study will examine the safety and effectiveness of AMG 827 for the treatment of moderate
to severe Crohn's disease. Patients will randomly receive either AMG 827 or placebo (a
lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient
will know what treatment is being given.


Inclusion Criteria:

- Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6
months prior to initiating Study Product

- Moderately to severely active Crohn's disease, as defined by a CDAI score >250 and
<450 at baseline

- Evidence of active inflammation

Exclusion Criteria:

- Short bowel syndrome

- Stricture with obstructive symptoms within 3 months

- Bowel surgery within 3 months

- Ileostomy and/or colostomy

- Any gastric or intestinal pouch

- Ulcerative colitis

- Evidence of an infected abscess

- Bowel perforation or evidence of noninflammatory obstruction during the 6 months
Stool positive for C. Difficile toxin at screening

- Presence of active infection requiring treatment

- Serious infection within 8 weeks

- Significant concurrent medical conditions

- Pregnant or breast feeding

- Significant Laboratory abnormalities

- Any anti-TNF agent within 2 months

- Steroid enemas within 2 weeks

- Tysabri (natalizumab) within 1 year

- Biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 3
months

- Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus
within 2 months
We found this trial at
19
sites
Egg Harbor Township, New Jersey 08234
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Egg Harbor Township, NJ
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Birmingham, AL
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Charlotte, North Carolina 28207
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Charlotte, NC
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Chevy Chase, MD
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Dithan, AL
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Germantown, TN
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from
Great Neck, NY
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Hammond, LA
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from
Jacksonville, FL
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Kurralta Park, South Australia 5037
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Kurralta Park,
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from
Logan, UT
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Lowell, AR
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Mexico, MO
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from
Miami, FL
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from
Nashville, TN
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from
Ogden, UT
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from
Rochester, MN
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from
San Antonio, TX
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Wilmington, North Carolina 28401
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from
Wilmington, NC
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