Study of Efficacy, Safety and Effect on Radiographic Progession of Brodalumab in Subjects With Psoriatic Arthritis



Status:Terminated
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2014
End Date:October 2015

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A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-1

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.


Inclusion Criteria:

- Subject has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic
Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding the
distal interphalangeal joints)).

- 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 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
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