Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
ConditionActive Juvenile Psoriatic Arthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-17
SponsorAmgen
About this trial
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
Qualifiers
Male or Female participants 5 to < 18 years of age at the time of randomization.
Arthritis and psoriasis, OR
Dactylitis
Nail pitting or onycholysis
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Apremilast
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov