Treatment of active juvenile psoriatic arthritis in children using apremilast

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy of apremilast, a medication used to treat inflammatory disorders, compared to a placebo in children aged 5 to less than 18 years with active juvenile psoriatic arthritis (JPsA). Participants must have a confirmed diagnosis of JPsA and show inadequate response or intolerance to previous treatments. The study will involve randomization to receive either apremilast or a placebo over a specified period to assess improvements in their condition.

Why it matters

Who can join: the full rules

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).

Where it's running

• Hospices Civils de Lyon Hopital Femme Mere Enfant
  Bron, France Recruiting
• Hopital Jeanne de Flandre
  Lille, France Recruiting
• Charite - Universitaetsmedizin Berlin, Campus Virchow
  Berlin, Germany Recruiting
• General Hospital of Thessaloniki Ippokrateio
  Thessaloniki, Greece Recruiting
• Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
  Milan, Italy Recruiting
• Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine
  Vilnius, Lithuania Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating Bimekizumab for Pediatric Arthritis

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• Using Apremilast to treat oral ulcers in children with Behçet's disease or juvenile psoriatic arthritis

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• Xeljanz safety and effects in Korean children with juvenile idiopathic arthritis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.