Juvenile Idiopathic Arthritis
Conditions
Brief summary
The primary outcomes of this study are the proportion of study participants with a disease flare* during the first 12 months follow-up compared between each of the two drug withdrawal arms and the stable treatment arm., *Disease flare is defined as a combination of: A clinical significant increase in Juvenile Arthritis Disease 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 that a clinically significant flare has occurred with need of intensification of antirheumatic (DMARD) treatment.
Detailed description
The proportion of study participants with a disease flare* during the first 12 months follow-up compared between the two drug withdrawal arms., Time to flare and time to regain inactive disease after flare, Changes in validated measures of disease activity, Reports of adverse events, serious adverse events and suspected unexpected adverse reactions
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes of this study are the proportion of study participants with a disease flare* during the first 12 months follow-up compared between each of the two drug withdrawal arms and the stable treatment arm., *Disease flare is defined as a combination of: A clinical significant increase in Juvenile Arthritis Disease 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 that a clinically significant flare has occurred with need of intensification of antirheumatic (DMARD) treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of study participants with a disease flare* during the first 12 months follow-up compared between the two drug withdrawal arms., Time to flare and time to regain inactive disease after flare, Changes in validated measures of disease activity, Reports of adverse events, serious adverse events and suspected unexpected adverse reactions | — |
Countries
Norway