Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Etanercept concentration-time courses
研究概览
简要总结
The purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis
详细描述
Etanercept, a fully human soluble tumor necrosis factor (TNF) receptor fusion protein, has been demonstrated to be safe and efficacious for the treatment of patients with polyarticular JIA. However, many patients experience primary or secondary response failure, suggesting that individualization of treatment regimens may be beneficial. It has been shown that the clinical response to two anti-TNFalpha biological agents (infliximab, adalimumab) closely follows the trough drug levels and the presence of antibodies directed against the drugs. This study was undertaken to investigate whether serologic monitoring of etanercept bioavailability and immunogenicity in individual patients with JIA would be useful in optimizing treatment regimens to improve efficacy and tolerability
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Juvenile Idiopathic Arthritis
- •Age <18 years and> 4 years (which corresponds to the pediatric AMM)
- •Patient on Etanercept treatment in the context of his usual care, whatever the dose (but the dose should remain stable in the weight during the study period). The patient must have received at least one injection of etanercept before participating in the study.
- •Signature of consent by the guardians of the child
- •Patient affiliate or entitled to a social security scheme
排除标准
- •Infection progressive
- •Pregnancy and lactation. For adolescents of reproductive age and sexually active, contraception should be used during the duration of treatment with etanercept
- •Contraindication to treatment with Etanercept
- •Refusal of the study
结局指标
主要结局
Etanercept concentration-time courses
时间窗: one year
estimate etanercept population pharmacokinetic parameters and concentration-effect(s) relationship(s) in patients younger than 18 years treated for juvenile idiopathic arthritis (JIA).
次要结局
- number of limited joints(one year)
- anti-etanercept antibodies levels(one year)
- analogical visual scale(one year)
- arthritis number(one year)
- Wallace criteria(one year)