Expired Study
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Dithan, Alabama


Purpose:

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.


Criteria:

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


NCT ID:

NCT01150890


Primary Contact:

Study Director
MD
Amgen


Backup Contact:

N/A


Location Contact:

Dithan, Alabama
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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