Biomarker-guided treatment-and-stop-strategy for short acting IL-1 blockade in patients with systemic Juvenile Idiopathic Arthritis.

Phase 1

Conditions: systemic Juvenile Idiopathic Arthritis
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2015-004393-16-NL

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to develop a biomarker guided treatment and stop strategy for rIL-1RA in systemic Juvenile Idiopathic Arthritis;Secondary Objective: - the total number of disease flares during or after tapering and stop of therapy in the first year<br>- the number of patients with remission off medication at time point 1 and 2 years<br>- the total number of injections of anakinra per patient in the first year<br>- the number of patients needing to switch treatment because of treatment failure during the first year <br>- the number of (serious) adverse events in the first year.;Primary end point(s): The number of patients with ‘clinically inactive disease’ without medication at time point 1 year after the start of anakinra (rIL-1RA);Timepoint(s) of evaluation of this end point: Time point 1 year after the start of anakinra (rIL-1RA)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): * the total number of disease flares during or after tapering and stop of therapy (rIL-1RA) in the first year;<br>* the number of patients with remission off medication at time point 1 and 2 years;<br>* the total number of injections of anakinra per patient;<br>* the number of patients needing to switch treatment because of treatment failure during the first year <br>* the number of (serious) adverse events in the first year.;Timepoint(s) of evaluation of this end point: Time point 1 and 2 years after the start of anakinra (rIL-1RA)