Juvenil Idiopatic Arthritis
Conditions
Brief summary
The primary outcome of this study is the proportion of study participants with a disease flare* during the first 12 months follow-up compared between the TNFi withdrawal group and the stable treatment group. *Disease flare is defined as a combination of: A clinically significant increase in JIA Activity Score 27 (JADAS-27) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents
Detailed description
Time to flare and time to regain inactive disease after flaring up to 12 months, Changes in validated measures of disease activity up to 12 months, Reports of adverse events, serious adverse events, and suspected unexpected adverse reactions up to 12 months
Interventions
DRUGHyrimoz 20 mg solution for injection in pre-filled syringe
Sponsors
Oslo Universitetssykehus HF
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the proportion of study participants with a disease flare* during the first 12 months follow-up compared between the TNFi withdrawal group and the stable treatment group. *Disease flare is defined as a combination of: A clinically significant increase in JIA Activity Score 27 (JADAS-27) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to flare and time to regain inactive disease after flaring up to 12 months, Changes in validated measures of disease activity up to 12 months, Reports of adverse events, serious adverse events, and suspected unexpected adverse reactions up to 12 months | — |
Outcome results
None listed