PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

Launched by AMGEN · Sep 30, 2010

Keywords

ClinConnect Summary

Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore, apremilast has the potential to be effective in the treat...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Males or females, aged ≥ 18 years at time of consent.
• • Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 6 months duration.
• • Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) PsA at time of screening.
• • Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
• • May not have axial involvement alone
• • Concurrent Treatment allowed with methotrexate, leflunomide, or sulfasalazine
• • Have ≥ 3 swollen AND ≥ 3 tender joints.
• • Males \& Females must use contraception
• • Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose oral corticosteroids allowed.
• Exclusion Criteria:
• • Pregnant or breast feeding.
• • History of allergy to any component of the investigational product.
• • Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening.
• • Therapeutic failure on \> 3 agents for PsA or \> 1 biologic tumor necrosis factor (TNF) blocker