Extension of Combination Therapy for Multiple Sclerosis (eCombiRx)

描述（由申请人提供）：CombiRx临床试验是一项随机，双盲，安慰剂对照，多中心随机研究，比较干扰素- β -la （IFN）和醋酸格拉替默（GA）联合作为复发-缓解型多发性硬化症（RR MS）的主要治疗药物的疗效。该研究所赞助项目的最初资金是在2003年11月。最初要求为北美各地的40个临床站点提供资金。在获得资金后，并根据同国家发展和开发计划署方案工作人员的协商，计划的地点数目增加到80个，以改善征聘工作。招募目标是1000名受试者，随机分配50%的受试者接受联合治疗，25%的受试者接受每种单一治疗药物和相匹配的安慰剂。本申请是为了延长这项资助，以完成对所有患者为期三年的研究方案随访。主要结局和其他结局指标与原始方案相同，我们扩大了分析以更好地评估残疾进展。继续研究计划，即所有受试者在其原始研究臂中进行随访，直到最后一位受试者完成所有三年的研究，该计划已获得研究DSMB和研究者的批准。

DESCRIPTION (provided by applicant): The CombiRx clinical trial is a randomized, double blind, placebo controlled, multi-center randomized study of the efficacy of combining interferon beta-la (IFN) and glatiramer acetate (GA) compared to either agent alone as primary therapy for relapsing-remitting MS (RR MS). The original funding of this NINDS sponsored project was in November 2003. Initially funding was requested for 40 clinical sites across North America. After funding, and based on consultation with NINDS program staff, the number of planned sites was increased to a target of 80 to improve recruitment. The recruitment goal is 1000 subjects, randomized 50% to combination therapy and 25% to each single therapeutic agent with a matched placebo. This application is for renewal of this grant to complete the follow up of all patients through three years on study protocol. The primary outcome and other outcome measures are unchanged from the original protocol and we have expanded the analyses to better assess disability progression. The continuation plan, which is to follow all subjects in their original study arm until the last subject has completed all three years of the study, has been approved by the study DSMB as well as the investigators.