NCT01105507已完成3 期
An Open Label Study to Assess the Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Safety & tolerability of canakinumab by measuring the maintenance of response over time using the Investigators Clinical Assessment of Disease Activity scale and the evaluation of serum inflammation markers CRP (C-Reactive Protein), SAA (Serum Amyloid A.
研究概览
简要总结
This study will assess the safety, tolerability and efficacy of canakinumab treatment in Canadian patient diagnosed with cryopyrin-associated periodic syndrome over a period of 18 months.
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
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients at least 4 years of age at the time of the screening visit
- •Patient's informed consent for > or = 18 years of age before any assessment is performed
- •Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients < 18 years of age.
- •Patients with a diagnosis of CAPS: FCAS/FCU, MWS, or NOMID/CINCA
- •Body weight > or = 15 kg
- •Able to communicate with the investigator and comply with the requirements of the study (for children the parent can assist when necessary)
排除标准
- •Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at baseline
- •Patient of childbearing potential (man or woman) and unwilling to use double barrier method of contraception. It is required that double barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients of childbearing potential (man or woman) regardless of whether a hormonal agent is also used as a method of contraception.
- •Participation in any clinical investigation within 4 weeks prior to dosing
- •Live vaccinations within 3 months prior to the start of the trial, during the trial and up to 3 months following the last dose.
- •History of significant medical conditions, which in the Investigator's opinion would exclude the patient from participating in this trial (this can be discussed with Novartis on a case by case basis in case of uncertainty).
- •History of drug or alcohol abuse within 12 months prior to dosing
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- •"Other protocol-defined inclusion/exclusion criteria may apply"
结局指标
主要结局
Safety & tolerability of canakinumab by measuring the maintenance of response over time using the Investigators Clinical Assessment of Disease Activity scale and the evaluation of serum inflammation markers CRP (C-Reactive Protein), SAA (Serum Amyloid A.
时间窗: 18 months
次要结局
- Change in long term maintenance of Health-Related Quality of Life and productivity measured from baseline to end of study.(Baseline, 18 months)
- Treatment adherence with canakinumab for the duration of the study.(18 months)
研究者
研究点 (2)
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