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ESTIS trial: Early Stop of targeted Treatment in children with Systemic JIA.
EU CTIS ID: 2024-518684-35-00
What this study is testing
The main hypothesis of this study is that the (average) number of injections rIL- 1RA per patient in order to achieve and maintain clinically inactive disease in the first year after the start of rIL-1RA, by making additional use of the biomarker IL-18, is lower than the average number of injections rIL-1RA that was necessary per patient in the first year after the start of rIL-1RA in our historical cohort (in which the decision to taper and stop with rIL-1RA was done only on clinical judgment of the treating physician).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.