Combination Therapy in Multiple Sclerosis

描述（由申请人提供）：本申请是一项随机对照临床试验，比较干扰素- β (IFN)与醋酸格拉替默（GA）联合治疗复发型多发性硬化症（MS）的疗效。目前，IFN和GA均可单独用于治疗复发型多发性硬化症，尽管这种方法有望在单独使用两种药物的临床试验中获得的适度疗效的基础上有所改善，但尚未进行联合用药的关键试验。此外，没有适当的随机对照研究比较IFN和GA的疗效。该试验将允许对每种药物单独和联合使用的相对疗效进行比较，以对抗单一药物的较好效果。由于这些都是昂贵的治疗方法，而且单独使用这些药物的效果并不好，因此开发更好的治疗方法非常重要。目前只有一种新药处于复发性多发性硬化症的III期试验中；因此，联合治疗是改善多发性硬化症复发患者治疗选择的最大希望。所采用的试验设计将作为比较和联合任何治疗多发性硬化症药物的标准，并将提供比以往任何对照多发性硬化症试验更长期的数据。

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.