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

• Status: Completed
• Trial end date: 2017-01-25
• 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.

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) 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