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
- 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
- •Diagnosis of polyarticular juvenile rheumatoid arthritis (JRA) according to the criteria of the American College on Rheumatology (ACR)
- •Disease activity inadequately controlled by nonsteroidal anti-inflammatory drugs (NSAIDs) or methotrexate (MTX)
- •Presence at screening of at least 5 swollen joints (not due to deformity) and at least 3 joints with limitation of passive motion with pain by passive motion or/and pain by pressure (tenderness)
- •Stable dosage of MTX for at least 12 weeks prior to the screening visit or discontinuation of MTX at least 14 days prior to baseline visit (Day 1)
- •Discontinuation of disease-modifying antirheumatic drugs (DMARDs) other than MTX at least 28 days before screening visit
排除标准
- •History of inflammatory joint disease other than JRA
- •Functional class IV JRA by ACR criteria
- •Clinically significant cardiac disease or laboratory abnormalities
- •Any subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study
研究组 & 干预措施
Adalimumab
干预措施: Adalimumab (Biological)
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)