Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

Korábbi kezelés

• Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).

Más betegség

• Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.

Életkor

• 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).

• 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.
• Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate [MTX] or biologic agents).