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, specifically in improving signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Key facts

Study ID

NCT01172938

Run by

Amgen

People needed

504

Starts

2010-06-02

Expected to finish

2016-10-27

Last updated by the study team

2020-06-19

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) 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

• Arizona Research Center — Phoenix, Arizona, United States
• UCSD-Thornton Hospital — La Jolla, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Inland Rheumatology Clinical Trials — Upland, California, United States
• Arthritis and Rheumatic Disease Specialties — Aventura, Florida, United States
• North Florida Dermatology — Jacksonville, Florida, United States
• Tampa Medical Group Pa — Tampa, Florida, United States
• Sonora Clinical Research, LLC — Boise, Idaho, United States
• Coeur D'Alene Arthritis Clinic — Coeur d'Alene, Idaho, United States
• The Arthritis Center — Springfield, Illinois, United States
• St. Francis Hospital and Health Centers — Michigan City, Indiana, United States
• The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
• Justus Fiechtner MD PC — Lansing, Michigan, United States
• Physicians East — Greenville, North Carolina, United States
• Carolina Bone and Joint — Monroe, North Carolina, United States
• Piedmont Medical Research Associates Inc — Winston-Salem, North Carolina, United States
• Health Research of Oklahoma — Oklahoma City, Oklahoma, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Clinical Research Center of Reading, LLP — West Reading, Pennsylvania, United States
• Dermatology Treatment and Research Center — Dallas, Texas, United States
• Accurate Clinical Research Inc — Houston, Texas, United States
• Arthritis and Osteoporosis Associates LLP — Lubbock, Texas, United States
• Center for Clinical Studies — Webster, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Achieve Clinical Research LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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