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New treatment option for Active Juvenile Psoriatic Arthritis
Official title Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
ClinicalTrials.gov ID: NCT04804553
What this study is testing
What is Apremilast?
Apremilast is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for active juvenile psoriatic arthritis.
Also referred to as Otezla®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 17
You may be able to join if
- 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...
- Arthritis and psoriasis, OR
- Arthritis with at least 2 of the following:
- Dactylitis
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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).
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Bregenz, Austria
- Ghent, Belgium
- Liège, Belgium
- Merksem, Belgium
- Bron, France
- Lille, France
- Berlin, Germany
- Dresden, Germany
- Hamburg, Germany
- Sankt Augustin, Germany
- Athens, Greece
- Thessaloniki, Greece
- Chieti, Italy
- Genova, Italy
- Milan, Italy
- Roma, Italy
- Vilnius, Lithuania
- Utrecht, Netherlands
- Krakow, Poland
- Lodz, Poland
+ 20 more site(s).
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, 5 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bregenz, Austria; Ghent, Belgium; Liège, Belgium; Merksem, Belgium; Bron, France; Lille, France and 34 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.