Real-World Treatment Study of Soliris (Eculizumab)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- safety assessment of soliris
研究概览
简要总结
As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients who are treated with Soliris in normal clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Soliris under conditions of routine daily medical practice in Korea.
This study will provide information on the population of Korean patients who are treated with Soliris.
详细描述
The Korea Risk Management Plan (K-RMP) of Soliris Inj. 300mg (eculizumab, hereinafter referred to as 'Soliris' or study drug) includes Post-Marketing Surveillance (PMS) as part of the pharmacovigilance plan in accordance with 'Article 7-2 of Regulation on Pharmaceuticals Approval, Notification and Review'.
This study will be conducted to prepare data on drug use results required for post- marketing re-examination application of Soliris and the purpose of the study is to identify the safety under real world practice.
Soliris was approved by the Ministry of Food and Drug Safety on February 18, 2021 for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP-4) antibody positive, and a 4 years of re-examination period was given based on the approval date of the indication and usage change.
The re-examination period for Soliris is calculated as February 17, 2025 in accordance with the 'Standards for Re-examination of New Drugs, etc.' This study includes about 11 adult patients with NMOSD positive for anti-aquaporin-4 (AQP-4) antibody currently treated with or initiating treatment with Soliris .
It will be conducted as a total surveillance method in which each subject who received the drug is recorded in the case report form during the study period. In addition, efforts will be made to conduct investigations on safety and efficacy, such as onset of side effect and expected effects, for all patients who received the product up to two years from the marketing date.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 or older with NMOSD positive for anti-aquaporin-4 (AQP-4) antibody who are receiving or starting treatment with Soliris according to the product label
- •Patients who have been vaccinated against Neisseria meningitidis at least 2 weeks prior to receiving the first dose of Soliris. However, patients who receive Soliris within 2 weeks after Neisseria meningitidis vaccination should receive treatment with appropriate prophylactic antibiotics for 2 weeks after vaccination
- •Patient who understood and consented to the written informed consent provided.
排除标准
- •Patients with hypersensitivity to eculizumab, murine protein, or any other component of Soliris
- •Patients with untreated serious Neisseria meningitidis infection.
结局指标
主要结局
safety assessment of soliris
时间窗: 24 weeks
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
次要结局
- efficacy assessment of Soliris(24 weeks)