Ziemssen Tjalf, Engelmann Ulrich, Jahn Sigbert, Leptich Alexandra, Kern Raimar, Hassoun Lina, Thomas Katja
Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.
Medical Affairs, Genzyme GmbH, Neu-Isenburg, Germany.
BMC Neurol. 2016 Jul 19;16:109. doi: 10.1186/s12883-016-0629-9.
Alemtuzumab, a humanized monoclonal antibody directed against the cell surface glycoprotein CD52, is licensed in Europe since October 2013 as treatment for adult patients with active relapsing-remitting multiple sclerosis (RRMS). In three randomized, rater-blinded active comparator clinical trials studies, alemtuzumab administered in two annual courses, had superior efficacy as compared to subcutaneous interferon beta-1a, and durable efficacy over 5 years in an extension study with a manageable safety profile in RRMS patients. Data on the utilization and the outcomes of alemtuzumab under clinical practice conditions are limited.
Here we describe the rationale, design and methods of the TREAT-MS study (non-interventional long-Term study foR obsErvAtion of Treatment with alemtuzumab in active relapsing-remitting MS).
TREAT-MS is a prospective, multicenter, non-interventional, long-term study to collect data on safety, effectiveness, quality of life, cognition and other aspects from 3200 RRMS patients treated with alemtuzumab under the conditions of real-world clinical practice in Germany.
As non-interventional trial in Germany.
阿仑单抗是一种针对细胞表面糖蛋白CD52的人源化单克隆抗体，自2013年10月起在欧洲获批用于治疗成年复发缓解型多发性硬化症（RRMS）患者。在三项随机、评估者盲法、活性对照临床试验中，阿仑单抗分两个年度疗程给药，与皮下注射干扰素β-1a相比疗效更佳，并且在一项扩展研究中，其在RRMS患者中显示出长达5年的持久疗效，安全性可控。关于阿仑单抗在临床实践条件下的使用情况和结果的数据有限。
在此，我们描述了TREAT-MS研究（复发缓解型多发性硬化症阿仑单抗治疗观察的非干预性长期研究）的基本原理、设计和方法。
TREAT-MS是一项前瞻性、多中心、非干预性长期研究，旨在从德国现实临床实践条件下接受阿仑单抗治疗的3200例RRMS患者中收集有关安全性、有效性、生活质量、认知及其他方面的数据。
作为德国的非干预性试验。
