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

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT01212757

Run by

Amgen

People needed

488

Starts

2010-09-27

Expected to finish

2017-01-25

Last updated by the study team

2020-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Denver Arthritis Clinic — Denver, Colorado, United States
• New England Research Associates, LLC — Trumbull, Connecticut, United States
• Centre For Rheumatology, Immun. And Arthritis — Fort Lauderdale, Florida, United States
• DMI Research — St. Petersburg, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Arthritis and Rheumatology of Georgia — Atlanta, Georgia, United States
• Michael Bukhalo MD SC — Arlington Hts, Illinois, United States
• Associated Internal Medical Specialist, PC — Battle Creek, Michigan, United States
• Advanced Rheumatology — Lansing, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Research West Incorporated — Kalispell, Montana, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Vital Research — Greensboro, North Carolina, United States
• Unifour Medical Research Associatets LLC — Hickory, North Carolina, United States
• Rheumatic Disease Associates — Willow Grove, Pennsylvania, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States
• Baylor Research Institute — Dallas, Texas, United States
• Arthritis Care and Diagnostic Center — Dallas, Texas, United States
• Luckster Enterprises — San Antonio, Texas, United States
• Seattle Rheumatology Associates — Seattle, Washington, United States
• Tacoma Center for Arthritis Research, PS — Tacoma, Washington, United States
• Rheumatology and Immunotherapy Center — Franklin, Wisconsin, United States
• CHU Brugmann — Brussels, Belgium
• UZ Gent — Ghent, Belgium
• Clinical and Translational Research Center of Alabama, PC — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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