Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
168 participants
INTERVENTIONAL
2011-10-31
2015-09-30
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
TRIPLE
Study Groups
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AMG 827 140
140 mg AMG 827
AMG 827 140
140 mg AMG 827 SC (subcutaneous)
Placebo SC
Placebo
Placebo
Placebo SC (subcutaneous)
AMG 827 280
280 mg AMG 827
AMG 827 280
280 mg AMG 827 SC (subcutaneous)
AMG 827 210
AMG 827 SC 210 mg
AMG 827 210
210 mg AMG 827 SC (subcutaneous)
Interventions
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AMG 827 140
140 mg AMG 827 SC (subcutaneous)
Placebo
Placebo SC (subcutaneous)
AMG 827 280
280 mg AMG 827 SC (subcutaneous)
AMG 827 210
210 mg AMG 827 SC (subcutaneous)
Eligibility Criteria
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Inclusion Criteria
* Subject has ≥ 3 tender and ≥ 3 swollen joints
Exclusion Criteria
* Significant concurrent medical conditions
* Pregnant or breast feeding
* Significant Laboratory abnormalities
* Use of sulfasalazine, hydroxychloroquine, systemically administered calcineurin inhibitors, azathioprine, parenteral corticosteroids including intramuscular or intraarticular administration, or live vaccines within 28 days
* Use of anti-TNF therapy within 2 months
* Use of an anti-interleukin (IL)12/IL-23 drug or other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months
* Prior use of rituximab
* Prior use of anti-IL-17 biologic therapy, including AMG 827
18 Years
75 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
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
Peoria, Arizona, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Hemet, California, United States
Research Site
Huntington Beach, California, United States
Research Site
La Jolla, California, United States
Research Site
Los Angeles, California, United States
Research Site
Palm Desert, California, United States
Research Site
Palo Alto, California, United States
Research Site
Victorville, California, United States
Research Site
Sarasota, Florida, United States
Research Site
Boise, Idaho, United States
Research Site
Lexington, Kentucky, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Frederick, Maryland, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
Lansing, Michigan, United States
Research Site
Lebanon, New Hampshire, United States
Research Site
Rochester, New York, United States
Research Site
Portland, Oregon, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Seattle, Washington, United States
Research Site
Victoria, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Newmarket, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Trois-Rivières, Quebec, Canada
Research Site
Québec, , Canada
Countries
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References
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Mease PJ, Genovese MC, Greenwald MW, Ritchlin CT, Beaulieu AD, Deodhar A, Newmark R, Feng J, Erondu N, Nirula A. Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. N Engl J Med. 2014 Jun 12;370(24):2295-306. doi: 10.1056/NEJMoa1315231.
Mease PJ, Genovese MC, Mutebi A, Viswanathan HN, Chau D, Feng J, Erondu N, Nirula A. Improvement in Psoriasis Signs and Symptoms Assessed by the Psoriasis Symptom Inventory with Brodalumab Treatment in Patients with Psoriatic Arthritis. J Rheumatol. 2016 Feb;43(2):343-9. doi: 10.3899/jrheum.150182. Epub 2016 Jan 15.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20101227
Identifier Type: -
Identifier Source: org_study_id
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