A Multicenter Prospective Longitudinal Study of Clinical Outcomes, Disease Course, Health-Related Quality of Life, and Health Care Resource Utilization in Adult Patients With Multifocal Motor Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- argenx
- 入组人数
- 413
- 试验地点
- 114
- 主要终点
- To characterize MMN patient profiles for participants
研究概览
简要总结
This prospective longitudinal study will follow participants with Multifocal Motor Neuropathy over time and collect data on their clinical outcomes, quality of life, and use of health care resources. Participants will follow their regular visit schedule with their treating physician, except for an optional second visit occurring 7 to 14 days after the start of the study to collect biomarker data. No IMP will be administered.
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
- •Is at least the local legal age of consent for clinical studies when signing the ICF
- •Is capable of providing signed informed consent and complying with protocol requirements
- •Has an existing or new diagnosis of MMN made by a neuromuscular specialist or neurologist
排除标准
- •Is currently participating in any clinical study with an IMP
- •Has other medical conditions that could affect the assessment of MMN
结局指标
主要结局
To characterize MMN patient profiles for participants
时间窗: up to 61 months
To assess the MMN disease management and disease course
时间窗: up to 61 months
To assess outcome measures specific to MMN disease and their evolution over time
时间窗: up to 61 months
To estimate the burden of MMN on participants' quality of life
时间窗: up to 61 months
To estimate the economic burden for participants with MMN
时间窗: up to 61 months
To collect data on relevant disease biomarkers
时间窗: up to 61 months
次要结局
未报告次要终点