Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

Launched by AMGEN · Mar 16, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called apremilast to see how well it works in treating active juvenile psoriatic arthritis (JPsA) in children aged 5 to under 18 years. JPsA is a type of arthritis that causes joint pain and is often linked with psoriasis, a skin condition. The researchers want to compare the effects of apremilast with a placebo, which is a harmless substance that looks like the real medicine but doesn’t contain any active ingredients.

To be eligible for the trial, children need to have been diagnosed with JPsA for at least six months, have active symptoms like pain in three or more joints, and have not responded well to other arthritis treatments. The study is currently looking for participants, and those who join can expect regular check-ups to monitor their health and progress. This trial is important because it could help find new treatment options for children dealing with this challenging condition.

Gender

ALL

Eligibility criteria

• 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.
• • 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).