AVONEX IN TREATMENT OF SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS

该中心是北美和欧洲约45家参与biogen赞助的III期临床协议的机构之一。该试验的主要目的是确定与安慰剂相比，每周肌肉注射重组干扰素β -1a （Avonex）是否能有效减缓继发性进行性多发性硬化症（MS）的进展。进展将通过复合结果测量来评估，包括计时25英尺步行，9孔钉测试和节奏听觉串行加法测试（PASAT 3）。本研究的次要目标包括：1)确定Avonex在继发性进展性MS患者中每周给药剂量为60 mcg的安全性；2)确定积极治疗对年度磁共振成像（MRI）发现钆增强病变数量的影响；3)评估积极治疗对年度t2加权MRI发现的新病变和扩大病变数量的影响，以及4)评估积极治疗患者与安慰剂患者相比，基线扩展残疾状态量表（EDSS）评分的确认变化程度。大约436名继发性进展性MS患者被招募到这项研究中。

This center is one of about 45 institutions in North America and Europe participating in the Biogen-sponsored Phase III clinical protocol. The primary objective of this trial is to determine if weekly intramuscular injections of recombinant interferon beta-1a (Avonex) is effective in slowing the progression of secondary progressive multiple sclerosis (MS) when compared to placebo. Progression will be assessed by a composite outcome measure consisting of the timed 25 foot walk, 9-hole peg test and Paced Auditory Serial Addition Test (PASAT 3). Secondary objectives of this study include: 1) determining the safety of Avonex administered at a weekly dose of 60 mcg in patients with secondary progressive MS; 2) determining the effect of active therapy on the number of gadolinium enhanced lesions found on annual magnetic resonance imaging (MRI); 3) evaluating the effect of active therapy on the number of new and enlarging lesions found on T2-weighted annual MRI, and 4) evaluating the extent of confirmed change from baseline Expanded Disability Status Scale (EDSS) score for actively treated patients compared to those on placebo. Approximately 436 patients with secondary progressive MS were recruited to this study.