克拉迪宾对患者报告结果及其临床和生物识别相关的高活性复发性多发性硬化在第一次切换中的影响:观察性,多中心,前性,第四期CLADFIT-MS研究
Giovanna Borriello1,2, Clara Grazia Chisari3,4, Davide Maimone5
1Multiple Sclerosis Center, San Pietro Fatebenefratelli Hospital, Rome, Italy.
Frontiers in neurology
|August 8, 2024
概括
这项研究研究了克拉德里宾片如何影响多发性硬化症 (MS) 患者报告的结果. 它评估了高度活跃的复发性多发性硬化症切换治疗的成年人的身体功能,心理影响和活动水平.
科学领域:
- 神经学 神经学
- 临床研究 临床研究
- 患者报告的结果
背景情况:
- 患者报告的结果 (PROs) 对于了解多发性硬化症 (MS) 和其治疗对患者日常生活的影响至关重要.
- 评估PRO提供了超越临床措施对治疗有效性的宝贵见解.
- 常规临床实践数据补充了受控试验的发现.
研究的目的:
- 为了前性地评估cladribine片对高活性复发性MS的成年人PROs的影响.
- 评估转换为克拉德里宾片后PROs,残疾和体育活动之间的相关性.
- 了解患者的体验和自我评估治疗影响在现实世界中设置.
主要方法:
- 观察性研究协议涉及高活性复发性多发性硬化症的成年人从第一种疾病修饰药物 (DMD) 转换为克拉迪宾片.
- 主要终点:52周自我评估身体功能 (MSIS-29) 的变化.
- 二级终点:心理影响 (HADS),一般健康 (EQ-5D-5L),工作生产力 (WPAI:MS),PROMIS措施和可穿戴设备活动数据.
主要成果:
- 本文介绍了研究方案,以评估克拉德里宾片对患者报告结果的影响.
- 它旨在测量身体功能,心理健康和日常活动的变化.
- 数据将在52周内在现实世界临床环境中收集.
结论:
- 这项研究将提供关于高活性复发性多发性硬化症患者使用克拉迪宾片的患者经验的真实证据.
- 结果将提供关于治疗如何影响患者日常生活的见解,补充现有的试验数据.
- 这项研究强调了PROs在评估多发性硬化症治疗中的重要性.
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