Combination Therapy in Multiple Sclerosis

描述（由申请人提供）：本提案是一项随机对照临床试验，比较干扰素-β（IFN）与醋酸格拉替雷（GA）联合治疗复发型多发性硬化症（MS）的疗效。目前，IFN和GA都可单独用于治疗MS的复发形式。尚未进行联合药物的临床试验，尽管这种方法将提供改善单独药物临床试验中获得的适度疗效结果的希望。此外，没有适当的随机对照研究比较IFN与GA的疗效。本试验将允许比较每种药物单独使用和联合使用与更好的单一药物的相对疗效。由于这些都是昂贵的治疗和药物单独的结果是温和的，这是非常重要的，以开发更好的治疗方式。目前只有一种新药处于复发性MS的III期试验中;因此，联合治疗是改善复发性MS患者治疗选择的最佳希望。采用的试验设计将作为比较和联合任何治疗药物治疗MS的标准，并将提供比任何先前对照MS试验更长期的数据。

DESCRIPTION (provided by the applicant): This proposal is for a randomized, controlled clinical trial comparing the efficacy of combining interferon-beta (IFN) with glatiramer acetate (GA) to treat relapsing forms of multiple sclerosis (MS). At present, both IFN and GA are available, individually, for treatment of relapsing forms of MS. Pivotal trials combining agents have not yet been performed, although this approach would offer the hope of improving upon the modest efficacy results obtained in clinical trials of the agents individually. Further, there are no properly randomized, controlled studies comparing the efficacy of IFN to GA. This trial will allow for a comparison of the relative efficacy of each agent alone and in combination against the better of the single agents. As these are expensive therapies and the results of the agents alone are modest, it is of great importance to develop better therapeutic modalities. There is currently only one new agent in phase III testing for relapsing MS; thus, combination therapy is the best hope of improving treatment options for patients with relapsing MS. The trial design to be employed will serve as a standard for comparing and combining any of the therapeutic agents for treatment of MS and will provide longer-term data than any prior controlled MS trial.