PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

• Status: Completed
• Trial end date: 2017-02-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Celgene Corporation
• Treatments: Apremilast; Thalidomide

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) criteria for PsA at time of screening.

• Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)

• May not have axial involvement alone

• Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine

• Have ≥ 3 swollen AND ≥ 3 tender joints.

• Males & Females must use contraception

• Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed.

• Have at least one ≥2 cm psoriasis lesion

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