Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis Psoriasis Arthritis inflammation skin condition inflammatory cells apremilast CC-10004 phosphodiesterase type 4
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 504
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, specifically in improving 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: 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase arm 2: 30 mg Apremilast tablets administered twice a day for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice a day for up to 4.5 years in the active treatment / long-term safety phase orally twice daily arm 3: Placebo + 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 20 mg Apremilast twice daily at Week 16 arm 4: Placebo + 30 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 30 mg Apremilast twice daily at Week 16.

Interventions: intervention 1: Apremilast 20mg intervention 2: Apremilast 30mg intervention 3: Placebo + 20 mg Apremilast intervention 4: Placebo + 30 mg Apremilast
Intervention descriptions: intervention 1: Apremilast 20 mg twice daily, orally intervention 2: Apremilast 30 mg twice daily, orally intervention 3: Placebo + 20 mg Apremilast intervention 4: Placebo + 30 mg Apremilast

Protocol document: