Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | June 2, 2010 |
End Date: | October 27, 2016 |
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis
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.
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.
Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis
patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in
psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and
endothelial cells, and inflammatory cells attracted to the synovium by cytokines and
chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory
pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore,
apremilast has the potential to be effective in the treatment of PsA.
patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in
psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and
endothelial cells, and inflammatory cells attracted to the synovium by cytokines and
chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory
pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore,
apremilast has the potential to be effective in the treatment of PsA.
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) 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
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