A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- argenx
- 入组人数
- 680
- 试验地点
- 40
- 主要终点
- The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod
研究概览
简要总结
This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment
- •Have provided appropriate written informed consent
排除标准
- 未提供
研究组 & 干预措施
efgartigimod cohort
patients treated with efgartigimod
干预措施: efgartigimod (Biological)
non-efgartigimod cohort
patient treated with other MG medication
结局指标
主要结局
The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod
时间窗: up to 10 years
次要结局
未报告次要终点