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Apremilast Study in Children with Active Juvenile Psoriatic Arthritis
EU CTIS ID: 2023-503435-17-00
What this study is testing
Estimate the efficacy of apremilast compared with placebo in the treatment of Juvenile Psoriatic Arthritis in pediatric subjects 5 to less than 18 years of age
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or Female subjects 5 to less than 18 years of age at the time of randomization.
- Confirmed diagnosis of 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 at least 1 DMARD, (which may include MTX or biologic agents).
- Other protocol-defined inclusion criteria apply.
You likely can't join if
- Rheumatic autoimmune disease other than 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).
- Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include: rthritis 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 JIA
- Other protocol-defined exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- South Africa
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; South Africa; Turkey. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.