Status:
RECRUITING
Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
Lead Sponsor:
Amgen
Conditions:
Active Juvenile Psoriatic Arthritis
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
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 Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04804553
Start Date
March 17 2022
End Date
December 29 2028
Last Update
December 1 2025
Active Locations (43)
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1
Landeskrankenhaus Bregenz
Bregenz, Austria, 6900
2
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
3
Centre Hospitalier Regional de la Citadelle
Liège, Belgium, 4000
4
Ziekenhuis Netwerk Antwerpen Jan Palfijn
Merksem, Belgium, 2170