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: 6309226
• 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: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6309226
• 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约45个参与Biogen赞助的III期临床方案的机构之一。 本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展型多发性硬化症（MS）的进展。 将通过复合结局指标评估进展，该指标包括定时25英尺步行、9孔定位桩试验和起搏听觉连续加法试验（PASAT 3）。 本研究的次要目的包括：1）确定Avonex每周60 mcg给药在继发性进展性MS患者中的安全性; 2）确定活性治疗对每年磁共振成像（MRI）发现的钆增强病变数量的影响; 3）评估积极治疗对T2加权年度MRI上发现的新病灶和扩大病灶数量的影响，和4）评价与安慰剂组相比，积极治疗患者的扩展残疾状态量表（EDSS）评分从基线的确认变化程度。 本研究招募了约436例继发性进展性MS患者。