Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease
NCT ID: NCT01150890
Last Updated: 2022-01-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
130 participants
INTERVENTIONAL
2010-11-09
2011-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received placebo intravenously at baseline and week 4.
Placebo
Administered as as an intravenous (IV) infusion over at least 30 minutes.
Brodalumab 210 mg
Participants received 210 mg brodalumab intravenously at baseline and week 4.
Brodalumab
Administered as as an intravenous (IV) infusion over at least 30 minutes.
Brodalumab 350 mg
Participants received 350 mg brodalumab intravenously at baseline and week 4.
Brodalumab
Administered as as an intravenous (IV) infusion over at least 30 minutes.
Brodalumab 700 mg
Participants received 700 mg brodalumab intravenously at baseline and week 4.
Brodalumab
Administered as as an intravenous (IV) infusion over at least 30 minutes.
Interventions
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Brodalumab
Administered as as an intravenous (IV) infusion over at least 30 minutes.
Placebo
Administered as as an intravenous (IV) infusion over at least 30 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderately to severely active Crohn's disease, as defined by a CDAI score \>250 and \< 450 at baseline
* Evidence of active inflammation
Exclusion Criteria
* 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-tumor necrosis factor (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
18 Years
65 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Dothan, Alabama, United States
Research Site
Lowell, Arkansas, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Hammond, Louisiana, United States
Research Site
Chevy Chase, Maryland, United States
Research Site
Rochester, Minnesota, United States
Research Site
Mexico, Missouri, United States
Research Site
Egg Harbor, New Jersey, United States
Research Site
Great Neck, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Germantown, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
San Antonio, Texas, United States
Research Site
Logan, Utah, United States
Research Site
Ogden, Utah, United States
Research Site
Kurralta Park, South Australia, Australia
Research Site
Box Hill, , Australia
Research Site
Fitzroy, , Australia
Research Site
Fremantle, , Australia
Research Site
Bonheiden, , Belgium
Research Site
Ghent, , Belgium
Research Site
Leuven, , Belgium
Research Site
Roeselare, , Belgium
Research Site
Calgary, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Victoria, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Lille, , France
Research Site
Nice, , France
Research Site
Paris, , France
Research Site
Toulouse, , France
Research Site
Vandœuvre-lès-Nancy, , France
Research Site
Amsterdam, , Netherlands
Research Site
Maastricht, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Bydgoszcz, , Poland
Research Site
Olsztyn, , Poland
Research Site
Opole, , Poland
Research Site
Sopot, , Poland
Research Site
Pontevedra, Galicia, Spain
Research Site
Santiago de Compostela, Galicia, Spain
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2010-019544-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20090072
Identifier Type: -
Identifier Source: org_study_id
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