An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Long-term safety and tolerability of canakinumab and the retention rate of canakinumab-treated patients
研究概览
简要总结
This two-part open-label, multi-arm, non-comparative study will collect long-term safety, efficacy and tolerability data from patients who were responsive to canakinumab from study CACZ885G2301E1 (Cohort 1), and from patients who are treatment naïve to canakinumab (Cohort 2). In addition, the effect of inactivated vaccines in an SJIA patient population will be assessed for the development of adequate (protective) antibody levels following immunization according to respective local vaccination guidelines.
Study Part I:
All patients will be treated with canakinumab 4 mg/kg every 4 weeks (or 2 mg/kg every 4 weeks for Cohort 1 patients who are receiving that dose in CACZ885G2301E1) until study end unless discontinuation occurs, or until they qualify for Part II of the study.
Study Part II:
Patients who are eligible will be randomized to receive canakinumab at a reduced dose or prolonged dose interval (see requirements for dose reduction/dose interval prolongation below).
Patients in Cohort 1 receiving 2 mg/kg q4wk in CACZ885G2301E1 will not be randomized but will be part of the treatment arm canakinumab dose reduction if they are eligible.
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
- 2 Years 至 20 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
- 未提供
研究组 & 干预措施
Canakinumab - Cohort 1, 2mg
2 mg/kg q4wk (followed by taper to 1 mg/kg q4wk and drug discontinuation if appropriate)
干预措施: Canakinumab (Drug)
Canakinumab - Cohort 1, 4mg
4 mg/kg q8wk (followed by taper to 4 mg/kg q12wk and drug discontinuation if appropriate)
干预措施: Canakinumab (Drug)
Canakinumab - Cohort 2, 2mg
2 mg/kg q4wk (followed by taper to 1 mg/kg q4wk and drug discontinuation if appropriate)
干预措施: Canakinumab (Drug)
Canakinumab - Cohort 2, 4mg
4 mg/kg q8wk (followed by taper to 4 mg/kg q12wk and drug discontinuation if appropriate)
干预措施: Canakinumab (Drug)
Cohort 2 - canakinumab dose reduction
干预措施: ACZ885 (Drug)
Cohort 1 - canakinumab dose reduction
干预措施: ACZ885 (Drug)
结局指标
主要结局
Long-term safety and tolerability of canakinumab and the retention rate of canakinumab-treated patients
时间窗: Days 1 to 533
Outcome Measure Description: The long-term safety and tolerability of canakinumab and the retention rate of canakinumab-treated patients will be evaluated by monitoring of serious adverse events and adverse events leading to discontinuation of study drug.
次要结局
- The percentage of patients who meet the adapted pediatric ACR, its individual components, and the Juvenile Arthritis Disease Activity Score [JADAS] over time(Days 1 to 533)
- The level of systemic corticosteroid tapering achieved in Part I(Day 1 to start of Part II)
- The level of canakinumab tapering achieved after randomization to the dose reduction arm or dose interval prolongation treatment arm in Part II(from start of Part II to Day 533)
- The time to treatment failure in Part II(from start of Part II to Day 533)