The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.
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 and week 24. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
478
210 mg brodalumab administered via subcutaneous injection
140 mg brodalumab administered via subcutaneous injection
Placebo administered via subcutaneous injection until week 24.
American College of Rheumatology (ACR) 20 Response
An ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components).
Time frame: 16 weeks
Psoriasis Area and Severity Index (PASI)75
PASI75 indicates that the subject has had a response of a 75% reduction on the severity of the psoriasis area based of off effected area size, erythema, scaling, and itching.
Time frame: 16 Weeks
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Research Site
Huntsville, Alabama, United States
Research Site
Tuscaloosa, Alabama, United States
Research Site
Peoria, Arizona, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Los Angeles, California, United States
Research Site
Mather, California, United States
Research Site
Murrieta, California, United States
Research Site
Palm Desert, California, United States
Research Site
Tustin, California, United States
Research Site
Upland, California, United States
...and 142 more locations