Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis
NCT ID: NCT02029495
Last Updated: 2017-05-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
478 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
* Subjects must have at least 1 psoriatic skin lesion as well as either ≥ 1 erosion on a centrally read radiograph or an elevated CRP.
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
Huntsville, Alabama, United States
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Tuscaloosa, Alabama, United States
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Peoria, Arizona, United States
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Scottsdale, Arizona, United States
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Los Angeles, California, United States
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Mather, California, United States
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Murrieta, California, United States
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Palm Desert, California, United States
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Tustin, California, United States
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Upland, California, United States
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Jupiter, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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Gainesville, Georgia, United States
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Meridian, Idaho, United States
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Springfield, Illinois, United States
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Bowling Green, Kentucky, United States
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Somerset, Kentucky, United States
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Frederick, Maryland, United States
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Wheaton, Maryland, United States
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Worcester, Massachusetts, United States
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Lansing, Michigan, United States
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Eagan, Minnesota, United States
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Omaha, Nebraska, United States
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Clifton, New Jersey, United States
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Great Neck, New York, United States
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Lake Success, New York, United States
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New York, New York, United States
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Plainview, New York, United States
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Asheville, North Carolina, United States
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Bend, Oregon, United States
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Portland, Oregon, United States
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Duncansville, Pennsylvania, United States
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Charleston, South Carolina, United States
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Hixson, Tennessee, United States
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Austin, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Danville, Virginia, United States
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Seattle, Washington, United States
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Beckley, West Virginia, United States
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Bridgeport, West Virginia, United States
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Glendale, Wisconsin, United States
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Hasselt, , Belgium
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Leuven, , Belgium
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Calgary, Alberta, Canada
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Calgary, Alberta, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Québec, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Brno, , Czechia
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Brno, , Czechia
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České Budějovice, , Czechia
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Ostrava-Trebovice, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Uherské Hradiště, , Czechia
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Pärnu, , Estonia
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Tallinn, , Estonia
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Cahors, , France
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Orléans, , France
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Rennes, , France
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Saint-Etienne, , France
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Toulouse, , France
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Tours, , France
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Heraklion, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Esztergom, , Hungary
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Nyíregyháza, , Hungary
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Székesfehérvár, , Hungary
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Szolnok, , Hungary
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Florence, , Italy
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Milan, , Italy
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Pavia, , Italy
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Roma, , Italy
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Roma (RM), , Italy
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Rome, , Italy
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Verona, , Italy
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Mexicali, Baja California Norte, Mexico
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Chihuahua City, Chihuahua, Mexico
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León, Guanajuato, 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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Distrito Federal, Mexico, 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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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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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Banská Bystrica, , Slovakia
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Lučenec, , Slovakia
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Rimavská Sobota, , Slovakia
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Žilina, , Slovakia
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Córdoba, Andalusia, Spain
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Granada, Andalusia, Spain
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Seville, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Sabadell, Catalonia, Spain
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Mérida, Extremadura, Spain
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A Coruña, Galicia, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Villajoyosa, Valencia, Spain
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Basel, , Switzerland
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Zurich, , Switzerland
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Birmingham, , United Kingdom
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Glasgow, , United Kingdom
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Hull, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-003554-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20090406
Identifier Type: -
Identifier Source: org_study_id
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