Polman C H, Dahlke F, Thompson A J, Ghazi M, Kappos L, Miltenburger C, Pozilli C
Department of Neurology, Free University Hospital, Amsterdam, The Netherlands.
Mult Scler. 1995;1 Suppl 1:S51-4.
This manuscript describes the outline of a double-blind, placebo-controlled, (European), multicentre phase III study to evaluate the safety and efficacy of 8 MIU of interferon beta-Ib given subcutaneously every other day for 3 years in patients with secondary progressive multiple sclerosis. The primary efficacy variable of this trial is the time to confirmed neurological deterioration as documented by the Expanded Disability Status Scale. The essentials of the study design are presented, including the rationale for the performance of the study and the selection of both clinical and magnetic resonance imaging outcome parameters.
本手稿描述了一项双盲、安慰剂对照、（欧洲）多中心III期研究的概要，该研究旨在评估每隔一天皮下注射8百万国际单位β-1b干扰素，持续3年，用于继发进展型多发性硬化症患者的安全性和有效性。该试验的主要疗效变量是根据扩展残疾状态量表记录的确诊神经功能恶化时间。文中介绍了研究设计的要点，包括开展该研究的基本原理以及临床和磁共振成像结局参数的选择。
