An Extension Study of CACZ885N2301 (NCT02059291), Multi-center, Open Label Study of Canakinumab in Japanese Patients With Periodic Fever Syndromes (Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyper Immunoglobulin D Syndrome ((Also Known as Mevalonate Kinase Deficiency) (HIDS/MKD), or Colchicine Resistant/Intolerant Familial Mediterranean Fever (crFMF))
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths
研究概览
简要总结
The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed Epoch 4 of the CACZ885N2301 study in Japan before the approval of canakinumab in Japan
- •Written informed consent. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients < 20 years of age
排除标准
- •Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study
研究组 & 干预措施
Canakinumab (ACZ885)
Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
干预措施: Canakinumab (AIN457) (Biological)
结局指标
主要结局
Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths
时间窗: Participants were followed for the duration until approval, an expected average of 3 months.
Participants were monitored for safety throughout the study.
次要结局
未报告次要终点