Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Volume of distribution (V)
研究概览
简要总结
The purpose of this study is to learn more about how adult and children's bodies use etanercept and how bodyweight influences how well etanercept works. This study will help us understand the proper dose of etanercept in obese children and adults.
详细描述
PRECISE is an open-label, single arm, single-center site study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of dosing interval-optimized etanercept in obese patients with Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis (JIA). Approximately 30 patients with JIA or RA who are starting etanercept standard-of-care will take part in the study.
Eligible patients will have blood collections before and after starting the biologic of interest to assess PK and disease activity. Five (5) blood samples will be collected through a combination of clinic and home visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Optimal dosing
Obese children (≥ 2 year old) and adults with juvenile idiopathic arthritis (JIA) or Rheumatoid Arthritis (RA) who are starting etanercept as part of their routine medical care.
干预措施: Etanercept Optimal dosing (Drug)
结局指标
主要结局
Volume of distribution (V)
时间窗: 6 weeks
Volume of distribution at steady state as measured by PK sampling
Clearance (CL)
时间窗: 6 weeks
Clearance at steady state as measured by PK sampling
次要结局
- Median prediction error between observed and model predicted concentrations(6 weeks)
- mean change in DAS28/JADAS27(Baseline, 6 weeks)