Conditions: Psoriatic Arthritis
Keywords: psoriasis Arthritis Psoriatic Arthritis inflammation skin condition inflammatory cells apremilast CC-10004 phosphodiesterase type 4
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 529
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Detailed description:
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 treatment of PsA.

Arms:
arm 1: Apremilast 20mg twice daily, orally arm 2: Apremilast 30mg twice daily, orally arm 3: Placebo + 20mg Apremilast tablets administered twice daily arm 4: Placebo + 30mg Apremilast tablets administered twice daily

Interventions: intervention 1: Apremilast 20mg intervention 2: Apremilast 30mg intervention 3: Placebo
Intervention descriptions: intervention 1: Apremilast 20mg twice daily, orally intervention 2: Apremilast 30mg twice daily, orally intervention 3: Placebo

Protocol document: