Combination Therapy in Multiple Sclerosis

描述(由申请人提供)：这项建议是一项随机对照临床试验，比较了联合使用β-干扰素(干扰素)和醋酸格拉替拉默(GA)治疗复发性多发性硬化症(MS)的疗效。目前，干扰素和赤霉素A均可单独用于治疗复发形式的多发性硬化症，目前尚未进行联合用药的关键试验，尽管这种方法有望在单独用药的临床试验中获得适度疗效的基础上有所改善。此外，还没有适当的随机对照研究比较干扰素和GA的疗效。这项试验将允许将每种药物单独和联合使用的相对疗效与单一药物中的较好药物进行比较。由于这些都是昂贵的治疗方法，而且单独使用这些药物效果不大，因此开发更好的治疗方式是非常重要的。目前只有一种新药物处于复发性多发性硬化症的第三阶段测试中；因此，联合疗法是改善复发性多发性硬化症患者治疗选择的最大希望。将采用的试验设计将作为比较和组合任何治疗多发性硬化症的治疗药物的标准，并将提供比任何先前的多发性硬化症对照试验更长期的数据。

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.