NL-OMON43845
Completed
Phase 4
Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis. - ESTIS trial: Early Stop of targeted Treatment in children with Systemic JIA
niversitair Medisch Centrum Utrecht0 sites55 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Still's disease
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 55
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Open label lead\-in (observational part):
- •1\. Children and adolescents diagnosed with sJIA (ILAR 2004 classification criteria);;2\. Both male and female patients, aged 8 months \- 16 years (anakinra is approved in children aged 8 months and older who suffer from CAPS, and as per definition, JIA has an onset before the age of 16\); ;3\. Parents or legal guardian (and the subject when age is appropriate) who are willing to sign the consent/assent forms.;Intervention part (tapering and stop phase):
- •1\. patients treated with rIL\-1RA as first line therapy showing an initial beneficial response (no fever on day 7\) to rIL\-1RA monotherapy (concomitant NSAID allowed);
- •2\. Achieving at least an ACRPed90 response without fever around point 90 days after start of therapy on rIL\-1RA mono therapy (concomitant NSAID allowed).
Exclusion Criteria
- •Open label lead\-in (observational part):
- •1\. An onset of Macrophage Activation Syndrome (MAS) simultaneously with sJIA or after the diagnosis of sJIA will lead to exclusion of a (potential) subject from participation in this study;;2\. Previous systemically administered corticosteroid treatment within 6 weeks before diagnosis and enrollment.;3\. Known exclusion criteria for the use of rIL\-1RA (renal failure, with a creatinin clearance rate of \< 30 ml/min or neutropenia with neutrophil counts of \< 1,5 \* 10e9/L).;Intervention part (tapering and stop phase):
- •1\. An onset of Macrophage Activation Syndrome (MAS) after the diagnosis of sJIA will lead to exclusion of a (potential) subject from participation in this study;2\. Patients with a relapse of sJIA in the open label lead\-in phase of the study will be excluded for the tapering and stop phase, and will switch treatment to concomitant corticosteroid treatment and/or other biological therapy (Tocilizumab or Canakinumab) upon the decision of the treating physician.
Outcomes
Primary Outcomes
Not specified
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