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 个研究点目标入组 55 人开始时间: 待定最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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).

•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.

发起方

niversitair Medisch Centrum Utrecht