Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis
NCT ID: NCT02024646
Last Updated: 2020-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
484 participants
INTERVENTIONAL
2014-03-31
2015-10-31
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
QUADRUPLE
Study Groups
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210 mg brodalumab
Administered via subcutaneous injections.
210 mg brodalumab
210 mg brodalumab administered via subcutaneous injection.
140 mg brodalumab
Administered via subcutaneous injection.
140 mg brodalumab
140 mg brodalumab administered via subcutaneous injection.
Placebo
Administered via subcutaneous injection until week 24.
Placebo
Placebo administered via subcutaneous injection until week 24.
Interventions
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210 mg brodalumab
210 mg brodalumab administered via subcutaneous injection.
140 mg brodalumab
140 mg brodalumab administered via subcutaneous injection.
Placebo
Placebo administered via subcutaneous injection until week 24.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subject has a planned surgical intervention between baseline and the week 52 evaluation.
* Subject has an active infection or history of infections.
* Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the Investigator to be clinically significant and uncontrolled.
* Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)
• Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety
18 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
Little Rock, Arkansas, United States
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Cypress, California, United States
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Hemet, California, United States
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Huntington Beach, California, United States
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La Jolla, California, United States
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Palm Desert, California, United States
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Palo Alto, California, United States
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Victorville, California, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Paducah, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Wheaton, Maryland, United States
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Boston, Massachusetts, United States
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Battle Creek, Michigan, United States
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Grand Rapids, Michigan, United States
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Lansing, Michigan, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Rochester, New York, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Waco, Texas, United States
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Chesapeake, Virginia, United States
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Seattle, Washington, United States
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Calgary, Alberta, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Waterloo, Ontario, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Bordeaux, , France
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Le Kremlin-Bicêtre, , France
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Lille, , France
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Lyon Cédex 3, , France
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Nantes, , France
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Paris, , France
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Paris, , France
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Reims, , France
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Frankfurt, , Germany
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Hanover, , Germany
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Hildesheim, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Eger, , Hungary
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Nyíregyháza, , Hungary
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Székesfehérvár, , Hungary
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Szolnok, , Hungary
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Szombathely, , Hungary
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Mexicali, Baja California Norte, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Ciudad Obregón, Sonora, Mexico
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Mérida, Yucatán, Mexico
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Gdansk, , Poland
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Gdynia, , Poland
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Grodzisk Mazowiecki, , Poland
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Katowice, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Stalowa Wola, , Poland
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Świdnik, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Chelyabinsk, , Russia
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Kemerovo, , Russia
Research Site
Kursk, , Russia
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Moscow, , Russia
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Petrozavodsk, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Smolensk, , Russia
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Voronezh, , Russia
Research Site
Yekaterinburg, , Russia
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-003553-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110144
Identifier Type: -
Identifier Source: org_study_id
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