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Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518684-35-00
Acronym
NL55231.041.16
Enrollment
68
Registered
2024-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autoimmune disorders, joint disorders synonym: Still's disease, systemic JIA

Brief summary

* The total (mean/median) number of injections of anakinra per patient necessary to achieve and maintain clinically inactive disease during the first year of treatment.

Detailed description

* The number of patients with *clinically inactive disease* without medication at time point 1 year., * The total number of disease flares during or after tapering and stop of therapy in the first year;, * The number of patients with remission off medication at time point 2 years;, * The number of patients needing to switch treatment because of treatment failure during the first year (to calculate reduction in treatment costs), * The number of (serious) adverse events in the first year.

Interventions

Sponsors

Universitair Medisch Centrum Utrecht
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
* The total (mean/median) number of injections of anakinra per patient necessary to achieve and maintain clinically inactive disease during the first year of treatment.

Secondary

MeasureTime frame
* The number of patients with *clinically inactive disease* without medication at time point 1 year., * The total number of disease flares during or after tapering and stop of therapy in the first year;, * The number of patients with remission off medication at time point 2 years;, * The number of patients needing to switch treatment because of treatment failure during the first year (to calculate reduction in treatment costs), * The number of (serious) adverse events in the first year.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026