An Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 8
- 主要终点
- Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully
研究概览
简要总结
This was a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA) data at Week 28 and 48 from this study supported a registration submission of canakinumab in the indication of SJIA in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection. Patients with resolved/previous hepatitis B infection (a negative HBs antigen, but a positive anti-HBs antibody and/or anti-HBc antibody).
- •With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and /or places the patient at unacceptable risk for participation.
- •With neutropenia (absolute neutrophil count < 1500/mm3) at screening.
研究组 & 干预措施
Canakinumab
All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg.
干预措施: Canakinumab (Biological)
结局指标
主要结局
Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully
时间窗: Week 28
To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully at Week 28
Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
时间窗: Week 8
Minimum Adapted ACR Pediatric 30 criteria is defined as improvement from baseline at least 30% in at least 3 of response variables 1 to 6 in Adapted ACR Pediatric response variables and no intermittent fever (i.e. axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. Adapted ACR Pediatric response variables consists of following 7 variables: 1. Physician's Global Assessment of disease activity on a 0-100 mm VAS; 2. Parent's or Patient's (if appropriate in age) Global Assessment of Patient's overall wellbeing based upon the 0-100 mm VAS in the Child Health Assessment Questionnaire (CHAQ); 3. Functional ability: CHAQ; 4. Number of joints with active arthritis; 5. Number of joints with limitation of motion; 6. Laboratory measure of inflammation: CRP (mg/L); 7. Absence of intermittent fever due to SJIA during the preceding week.
次要结局
- Percentage Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Standardized C-Reactive Protein (CRP)(Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164))
- Serum Concentration of Canakinumab(Baseline, Weeks 4, 24, 48, 72, 96, EOS (up to Week 164))
- Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time(Weeks 4, 8, 28, 48, 96, 144, end of study (EOS) (up to Week 164))
- Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Functional Ability Score(Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164))
- Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Active Arthritis(Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164))
- Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Limitation of Motion(Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164))
- Number of Participants Having Fever in the Adapted ACR Pediatric Criteria of Canakinumab Over Time(Baseline, Day 3, Weeks 2, 8, 28, 48, 56, 96, 124, 144, EOS (up to Week 164))
- Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Physician's Global Assessment of Disease Activity(Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164))
- Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Parent's or Patient's Global Assessment of Patient's Overall Well-being as Part of CHAQ(Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS up to Week 164)
- Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully Over Time(Weeks 28, 48, 96, 144, EOS (up to Week 164))
- Percentage of Participants Who Had Flares With Canakinumab Treatment Over Time(> Day3, to <= Week 124)
- Percentage of Participants Who Achieved Inactive Disease (With and Without Duration of Morning Stiffness) With Canakinumab Treatment Over Time(Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164))
- Absolute Change From Baseline of Corticosteroids Dose Reduction With Canakinumab Treatment Over Time(Baseline, Weeks 28, 48, 96, 144, EOS (up to Week 164))
- Pharmacodynamics (PD) Assessment: Total IL-1 Beta(Baseline, Weeks 4, 24, 48, 72, 96, EOS (up to Week 164))