A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 25
- 试验地点
- 12
- 主要终点
- Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16
研究概览
简要总结
To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with Polyarticular Juvenile Rheumatoid Arthritis
详细描述
This was an open-label long-term study that was completed following study drug approval in Japan for the treatment of JRA. Data are presented through Week 144 and for the final visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16
时间窗: Week 16
Response defined as at least 30% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 30% worsening in not more than 1 JRA criterion, compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion \[LOM\] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.
次要结局
- Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16(Week 16)
- Number of Subjects Achieving PedACR 30/50/70 Responses(Week 2, 4, 8, and 24, every 12 weeks from Week 24 to Week 60, and every 24 weeks from Week 72 to the final visit)
- Mean Serum Adalimumab Concentration(Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60)
- Number of Subjects Positive for Anti-adalimumab Antibodies (AAA)(Week 24 and Week 60)