INTERFERON BETA-1A AND GLATLRAMER ACETATE TO EITHER AGENT ALONE IN PATIENTS W/MS

干扰素 Beta-1A 和 Glatlramer Acetate 在患有 MS 的患者中单独使用任一药物

• 批准号: 7608472
• 负责人: CARLO S TORNATORE
• 金额: $ 3.5万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608472
• 关键词: Acetates; Clinical Trials; Commercial Sources; Computer Retrieval of Information on Scientific Projects Database; Copaxone; Funding; Goals; Grant; Institution; Interferon beta-1a; Interferon-beta1; Intervention; Outcome; Patients; Phase III Clinical Trials; Placebos; Randomized; Rate; Relapse; Relapsing-Remitting Multiple Sclerosis; Relative (related person); Research; Research Personnel; Resources; Source; United States National Institutes of Health; avonex; copolymer 1; size; trial comparing

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multi-center NIH-funded study with additional support from two commercial sources. The stated goal of this phase III study is "to determine whether the combination of interferon beta 1-a (Avonex) and glatiramer acetate (Copaxone) is an effective therapy for relapsing-remitting Multiple Sclerosis". A total of 20 patients (from the total of 1000 sought at 86 centers) will be seen at the GCRC. This is a large scale randomized clinical trial comparing the effects of a combination of two common interventions to each treatment alone (i.e., no placebo). The outcome on which efficacy will be compared is the relapse rate, the anticipated effect size of the combination is 35% in the relapse rate relative to either therapy alone.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项由美国国立卫生研究院资助的多中心研究，另外还有两个商业来源的支持。这项III期研究的既定目标是“确定干扰素β1-a(Avonex)和醋酸格列酮(Copaxone)的组合是否是治疗复发-缓解型多发性硬化症的有效疗法”。共有20名患者(在86个中心总共寻求1000名患者)将在GCRC就诊。这是一项大规模的随机临床试验，比较了两种常见干预措施的组合与每种治疗方法(即没有安慰剂)的效果。疗效将被比较的结果是复发率，联合治疗的预期效果大小是复发率中相对于任何一种治疗的35%。