2024-518684-35-00招募中4 期
Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis
Universitair Medisch Centrum Utrecht5 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年12月13日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 5
- 主要终点
- * The total (mean/median) number of injections of anakinra per patient necessary to achieve and maintain clinically inactive disease during the first year of treatment.
研究概览
简要总结
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).
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Open label lead-in (observational part):
- •Children and adolescents diagnosed with sJIA (ILAR 2004 classification criteria);
- •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);
- •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):
- •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);
- •Achieving at least an ACRPed90 response without fever around point 90 days after start of therapy on rIL-1RA mono therapy (concomitant NSAID allowed).
排除标准
- •Open label lead-in (observational part):
- •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;
- •Previous systemically administered corticosteroid treatment within 6 weeks before diagnosis and enrollment.
- •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):
- •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;
- •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.
结局指标
主要结局
* The total (mean/median) number of injections of anakinra per patient necessary to achieve and maintain clinically inactive disease during the first year of treatment.
* The total (mean/median) number of injections of anakinra per patient necessary to achieve and maintain clinically inactive disease during the first year of treatment.
次要结局
- * The number of patients with *clinically inactive disease* without medication at time point 1 year.
- * The total number of disease flares during or after tapering and stop of therapy in the first year;
- * The number of patients with remission off medication at time point 2 years;
- * The number of patients needing to switch treatment because of treatment failure during the first year (to calculate reduction in treatment costs)
- * The number of (serious) adverse events in the first year.
研究者
Dr. S.J. Vaster
Scientific
Universitair Medisch Centrum Utrecht
研究点 (5)
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