Extension of Combination Therapy for Multiple Sclerosis (eCombiRx)

描述(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，目的是比较联合干扰素-β-1a(干扰素)和醋酸格拉替拉默(GA)作为复发-缓解型多发性硬化症(RR MS)主要治疗药物与单独使用这两种药物的疗效。NINDS赞助的这个项目最初的资金是在2003年11月。最初要求为北美的40个临床站点提供资金。在提供资金后，并根据与NINDS计划工作人员的协商，计划的地点数量增加到80个，以改善招聘。招募目标是1000名受试者，随机50%接受联合治疗，25%接受每种单一治疗药物和匹配的安慰剂。这项申请是为了续期这项资助，以完成对所有患者进行为期三年的研究方案的随访。主要结果和其他结果指标与最初的议定书没有变化，我们扩大了分析范围，以更好地评估残疾进展。继续计划是跟踪所有受试者的原始研究，直到最后一个受试者完成所有三年的研究，已经得到研究dsmb和调查人员的批准。

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.