Overview
The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.
Eligibility
Inclusion Criteria:
- Male or Female participants 5 to < 18 years of age at the time of randomization.
- Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (JPsA)
according to the International League of Associations for Rheumatology (ILAR)
Edmonton Revision (Petty, 2001) classification criteria of at least 6 months
- duration
-
- Arthritis and psoriasis, OR
- Arthritis with at least 2 of the following:
- Dactylitis
- Nail pitting or onycholysis
- Psoriasis in a first-degree relative
- Active disease: at least 3 active joints (including distal interphalangeal joints).
- Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate [MTX] or biologic agents).
Exclusion Criteria:
- Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:
- Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
- Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
- History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
- Presence of systemic juvenile idiopathic arthritis (JIA).
- Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but
not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.
- Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).