Trial Condition(s):

Crohn’s disease

AMG 827 in Subjects with Moderate to Severe Crohn’s Disease

Bayer Identifier:

20090072

ClinicalTrials.gov Identifier:

NCT01150890

EudraCT Number:

Not Available

Terminated/Withdrawn

Trial 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.

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

Trial Summary

Enrollment Goal
130
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
N/A
Accepts Healthy Volunteers
No

Where to Participate

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Pontevedra, Spain

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Recruiting
 
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Santiago de Compostela, Spain

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Madrid, Spain

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Birmingham, United States

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Dithan, United States

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Lowell, United States

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Miami, United States

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Jacksonville, United States

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Hammond, United States

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Chevy Chase, United States

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Rochester, United States

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Mexico, United States

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Egg Harbor Township, United States

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Great Neck, United States

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Charlotte, United States

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Wilmington, United States

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Nashville, United States

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Germantown, United States

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San Antonio, United States

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Logan, United States

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Ogden, United States

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Calgary, Canada

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Vancouver, Canada

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Victoria, Canada

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Winnipeg, Canada

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Toronto, Canada

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Hamilton, Canada

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London, Canada

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Montreal, Canada

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Kurralta Park, Australia

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Barcelona, Spain

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Paris Cedex 10, France

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Box Hill, Australia

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Vandoeuvre les Nancy, France

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Fitzroy, Australia

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Paris, France

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Toulouse Cedex 09, France

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Nice Cedex 3, France

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Maastricht, Netherlands

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Bonheiden, Belgium

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Gent, Belgium

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Lille cedex, France

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Roeselare, Belgium

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Leuven, Belgium

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Fremantle, Australia

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Sopot, Poland

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Rotterdam, Netherlands

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Bydgoszcz, Poland

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Olsztyn, Poland

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Amsterdam, Netherlands

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Opole, Poland

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Trial Design