Juvenile psoriatic arthritis
Conditions
Brief summary
Number of participants achieving ACR Pedi 30 from baseline (week 0) to week 16
Detailed description
Change in subject's assessment of pain (a), Number of participants achieving ACR Pedi 20/50/70/90 (a), Change in Childhood Heath Assessment Questionnaire (CHAQ) (a), Change in Juvenile Arthritis Disease Activity Score (JADAS) (a), Refer to protocol for fully list of secondary endpoints., PASI-75 response at week 16 for subjects with a baseline psoriasis BSA equal or more than 3% (a), Number of participants who experience PsA flares (a)
Interventions
DRUGApremilast
DRUGApremilast placebo product is supplied to the clinic as 10
DRUG20 and 30 mg tablets and 5 mg/mL oral solution. The placebo product is the same as the drug product formulation except there is no active apremilast.
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants achieving ACR Pedi 30 from baseline (week 0) to week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in subject's assessment of pain (a), Number of participants achieving ACR Pedi 20/50/70/90 (a), Change in Childhood Heath Assessment Questionnaire (CHAQ) (a), Change in Juvenile Arthritis Disease Activity Score (JADAS) (a), Refer to protocol for fully list of secondary endpoints., PASI-75 response at week 16 for subjects with a baseline psoriasis BSA equal or more than 3% (a), Number of participants who experience PsA flares (a) | — |
Countries
Austria, Belgium, France, Germany, Greece, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Spain
Outcome results
None listed