AVONEX IN TREATMENT OF SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS

AVONEX 治疗继发性进行性多发性硬化症

• 批准号: 6265662
• 负责人: Jerry Saul Wolinsky
• 金额: $ 1.11万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265662
• 关键词: clinical research; drug administration rate /duration; drug administration routes; drug screening /evaluation; gadolinium; human subject; human therapy evaluation; interferon beta; magnetic resonance imaging; multiple sclerosis; nervous system disorder chemotherapy; outcomes research; pathologic process; placebos

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.

该中心是北美和欧洲参与生物遗传研究公司赞助的第三阶段临床方案的大约45家机构之一。这项试验的主要目标是确定与安慰剂相比，每周肌肉注射重组干扰素β-1a(Avonex)在减缓继发性进行性多发性硬化症(MS)进展方面是否有效。进展将通过综合结果测量来评估，包括定时25英尺步行、9孔钉试验和起搏听觉序列相加试验(PASAT 3)。本研究的次要目标包括：1)确定Avonex每周60微克对继发性进展性多发性硬化症患者的安全性；2)确定主动治疗对年度磁共振成像(MRI)中发现的Gd强化病变数量的影响；3)评估主动治疗对T2加权年度MRI发现的新病变和扩大病变数量的影响；以及4)评估与安慰剂相比，积极治疗的患者与服用安慰剂的患者相比，其基线扩展残疾状况量表(EDSS)评分的确认变化程度。大约436名继发性进展性多发性硬化症患者参加了这项研究。