Clinical trial NCT02024646: Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
Brodalumab
AMG 827
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-31
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.


Eligibility criteria: Inclusion Criteria:

Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal interphalangeal joints). Subjects must have at least

1 psoriatic skin lesion. Exclusion Criteria:

• -Subject has known history of active tuberculosis.

* 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

Primary outcomes:
measure: ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16
timeFrame: Baseline and 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Cypress
country: United States
facility: Research Site
state: California
city: Hemet
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Palm Desert
country: United States
facility: Research Site
state: California
city: Palo Alto
country: United States
facility: Research Site
state: California
city: Victorville
country: United States
facility: Research Site
state: California
city: Saint Petersburg
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Paducah
country: United States
facility: Research Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: Wheaton
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Battle Creek
country: United States
facility: Research Site
state: Michigan
city: Grand Rapids
country: United States
facility: Research Site
state: Michigan
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Rochester
country: United States
facility: Research Site
state: New York
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Waco
country: United States
facility: Research Site
state: Texas
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Waterloo
country: Canada
facility: Research Site
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Quebec
country: Canada
facility: Research Site
city: Bordeaux Cedex
country: France
facility: Research Site
city: Le Kremlin Bicetre
country: France
facility: Research Site
city: Lille cedex
country: France
facility: Research Site
city: Lyon Cédex 3
country: France
facility: Research Site
city: Nantes cedex 1
country: France
facility: Research Site
city: Paris Cedex 10
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Reims Cedex
country: France
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Lübeck
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Eger
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Mexicali
country: Mexico
facility: Research Site
state: Baja California Norte
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Ciudad Obregon
country: Mexico
facility: Research Site
state: Sonora
city: Merida
country: Mexico
facility: Research Site
state: Yucatán
city: Gdansk
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Stalowa Wola
country: Poland
facility: Research Site
city: Swidnik
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Kursk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: