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

niversity Medical Center Utrecht0 个研究点开始时间: 2016年7月8日最近更新: 2016年10月24日

适应症

试验速览

暂无简介。

•1. Children and adolescents diagnosed with sJIA;
•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. Patients treated with anakinra as first line therapy who showed an initial response to anakinra (no fever on day 7);
•4. Parents or legal guardian (and the subject when age is appropriate) who are willing to sign the consent/assent forms.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 55
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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 steroid treatment in the 3 months before diagnosis.

发起方