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Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

RECRUITINGPhase 3Sponsored by Amgen
Actively Recruiting
PhasePhase 3
SponsorAmgen
Started2022-03-17
Est. completion2028-03-21
Eligibility
Age5 Years – 17 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04804553

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

Age: 5 Years – 17 YearsHealthy volunteers accepted
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).

Conditions2

Active Juvenile Psoriatic ArthritisArthritis

Interventions1

Apremilast

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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