AVONEX IN TREATING MULTIPLE SCLEROSIS AFTER AN ISOLATED DEMYELINATING EVENT

本研究的目的是延迟首次和近期发生涉及视神经、脊髓或脑干的脱髓鞘事件以及多发性硬化（MS）高风险受试者的临床确诊多发性硬化（CDMS）发作。本研究的主要终点将是至发生CDMS的时间，由新发神经系统事件的发生确定，即，在开始研究药物治疗后至少30天神经系统稳定或改善的受试者中，新发神经系统症状持续超过48小时。 次要终点包括T2病灶体积从基线至第3年的变化、第3年钆增强病灶的数量和体积以及第3年新发或扩大的T2高信号病灶数量。 在所有受试者完成2年治疗后，将进行一次中期疗效分析。 该研究的规模是在假设50%的安慰剂治疗受试者将在3年内达到CDMS，而AVONEX tm治疗将使该百分比降至33%的情况下确定的。将在整个研究期间定期进行期中安全性分析。

The purpose of this study is to delay the onset of clinically definite multiple sclerosis (CDMS) in subjects who have experienced a first and recent onset of a demeyelinating event involving the optic nerve, spinal cord, or brainstem, and who are at high risk for multiple sclerosis (MS). The primary endpoint of the study will be the time to developement of CDMS as determined by the onset of a new neurological event, i.e., new neurological symptoms lasting more than 48 hours in a subject who had been neurologically stable or improving at least 30 days following initiation of study drug treatment. Secondary endpoints include change in T2 lesion volume from baseline to Year 3, number and volume of gadolinium-enhanced lesions at Year 3, and number of new or enlarged T2 hyperintense lesions at Year 3. One interm efficacy analysis will be performed after all subjects have completed 2 years of treatment. The study is sized under the assumption that 50% of subjects treated with placebo will reach CDMS by 3 years and that treatment with AVONEX tm will reduce this percentage to 33%. Interm safety analyses will be performed at intervals throughout the study.