PALACE 3: 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 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.

Key facts

Study ID

NCT01212770

Run by

Amgen

People needed

505

Starts

2010-09-30

Expected to finish

2017-02-09

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) 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

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

• Elite Clinical Studies, LLC — Phoenix, Arizona, United States
• Catalina Pointe Clinical Research Incorporated — Tucson, Arizona, United States
• Bakersfield Dermatology and Skin Cancer Medical Group — Bakersfield, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Joao Nascimento, MD — Bridgeport, Connecticut, United States
• In Vivo Clinical Research — Doral, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• Rheumatology Associates of Long Island — Orlando, Florida, United States
• Advent Clinical Research — Pinellas Park, Florida, United States
• Rockford Orthopedic Associates, LLC — Rockford, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• DermResearch, PLLC — Louisville, Kentucky, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Duke University Medical Center — Durham, North Carolina, United States
• STAT Research, Inc. — Dayton, Ohio, United States
• West Tennessee Research Institute — Jackson, Tennessee, United States
• Austin Dermatology Associates — Austin, Texas, United States
• Austin Regional Clinic — Austin, Texas, United States
• Center for Clinical Studies — Houston, Texas, United States
• Houston Medical Research — Houston, Texas, United States
• Texas Research Center — Sugar Land, Texas, United States
• Royal Prince Alfred Hospital — Camperdown, Australia
• Skin Cancer Foundation — Carlton, Australia
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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