INTRATHECAL INTERFERON AS THERAPY FOR MULTIPLE SCLEROSIS

目的：本提案的目的是获得必要的资金， 保护我们正在进行的双盲研究的科学完整性 多中心临床试验和荣誉我们的道德和伦理承诺 参与本研究的患者。 原始研究 设计预期在1983年1月1日至 7/1/83. 不幸的是，实际入组直到1984年7月20日才完成。 最初的研究承诺所有患者都能获得鞘内（IT）人类 成纤维细胞干扰素（IFN-B）后，他们已经在研究了两个 年 早期登记者预计将在2009年春季接受IFN-B治疗。 1985. 由于这项研究不会在八六年七月二十日之前完成，我们必须 准备向原始对照组（接受安慰剂）提供治疗 以保持研究盲态直至研究完成的方式。 方法：本临床试验完成两年后， 个别病人会接受额外治疗。 他们不会被 告知他们接受的既往治疗。 的患者 原始对照将被“交叉”以接受IT-IFN-B 24周， 根据协议时间表。 最初接受者 会得到假的LP。 关于急性加重和临床状态的数据 的病人将继续由统计中心传送到统计中心， 检查医生 要进行的系列实验室检查包括： NMR、CT、VER、CSF（IgG、MBP、寡克隆条带、IFN水平）和血清IFN 程度. 长期目标：如果IT-IFN-B在降低 如果病情恶化得到证实，那么这种治疗方法可以用于 在治疗MS患者的广泛基础上， 通过减少或消除病情加重而导致残疾。

Aims: The purpose of the present proposal is to obtain funds necessary to preserve the scientific integrity of our on-going double blinded multi-center clinical trial and to honor our moral and ethical commitment to the patients participating in the present study. The original study design anticipated enrollment of eighty patients between 1/1/83 and 7/1/83. Unfortunately, actual enrollment was not completed until 7/20/84. The initial study promised all patients access to intrathecal (IT) human fibroblast interferon (IFN-B) after they had been on the study for two years. Early enrollees expect to be treated with IFN-B in the spring of 1985. As the study will not be completed before 7/20/86, we must be prepared to offer treatment to the original controls (who received placebo) in a manner which preserves the blinding of the study until it is finished. Methodology: After completion of two years on the present clinical trial, individual patients will be offered additional treatment. They will not be informed as to the prior therapy which they received. Patients who were original controls will be "crossed over" to receive IT-IFN-B for 24 weeks, according to the protocol schedule. Patients who were original recipients will be given false LPs. Data regarding exacerbations and clinical status of patients will continue to be transmitted to the statistics center by the examining physician. Serial laboratory tests to be performed include: NMR, CT, VER, CSF (IgG, MBP, oligoclonal bands, IFN levels) and serum IFN levels. Long Term Objectives: If the efficacy of IT-IFN-B in reducing exacerbations is confirmed, then this method of treatment could be used on a widespread basis in the treatment of MS patients to prevent major disability via reduction or elimination of exacerbations.