INTRATHECAL INTERFERON AS THERAPY FOR MULTIPLE SCLEROSIS

目的：本提案的目的是获得必要的资金，以便 保持我们正在进行的双重失明的科学完整性 多中心临床试验和履行我们的道德和伦理承诺 对参与本研究的患者。最初的研究 设计预期纳入83年1月1日至83年1月期间的80名患者 83年7月1日。不幸的是，直到84年7月20日才完成实际注册。 最初的研究承诺所有患者都可以接触鞘内(IT)人类 成纤维细胞干扰素(干扰素-B)在他们已经进行了两次研究后 好几年了。早期参与者预计将在#年春季接受干扰素-B治疗 1985年。由于这项研究将不会在86年7月20日之前完成，我们必须 准备为最初的对照组(接受安慰剂)提供治疗 以一种使研究保持盲目性的方式，直到它完成。 方法：本临床试验结束两年后， 个别病人将获得额外的治疗。他们不会是 被告知他们之前接受过的治疗。曾经的病人 最初的对照将被“交叉”接受24周的IT-干扰素-B， 根据协议时刻表进行调度。最初接受治疗的患者 会得到虚假的有限合伙人。有关病情恶化和临床状况的数据 %的患者将继续通过 检查医生。将进行的一系列实验室测试包括： 核磁共振、CT、VER、脑脊液(IgG、MBP、寡克隆区带、干扰素水平)和血清干扰素 级别。 长期目标：IT-干扰素-B在降低 如果病情恶化，则这种治疗方法可以用于 广泛用于治疗多发性硬化症患者，预防重大 通过减轻或消除病情恶化而致残。

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.