IM RECOMBINANT BETA INTERFERON AS TREATMENT FOR MS

这项研究将确定肌肉内(IM)重组的疗效 人成纤维细胞干扰素治疗多发性硬化症 随机、双盲、安慰剂对照的硬化症(MS) 条件。 我们之前的双盲研究表明鞘内(IT) 天然干扰素-B能有效减轻MS的加重。企业的IT路线 该研究的用药是基于这样一种信念，即系统性干扰素- B未通过血脑屏障(BBB)。然而，有了新的 有证据表明，系统性干扰素-B确实穿过了迫使 多发性硬化患者全身应用干扰素的评估 这项多中心研究将包括288名活动性恶化的患者。 将被随机分配到IM接受r干扰素-B或 安慰剂。治疗将每周进行一次，为期104周。 疗效的主要衡量标准将是组间差异 按Kurtzke Expanded测量的残疾进展时间 至少1.0个单位的残疾等级，持续六个月。 此外，MS疾病活动性的其他一些重要参数 患者的功能状态将作为次要结果进行分析 措施。 我们最近完成的初步研究确定，6x106IU 每周一次肌注是重组干扰素-B的理想剂量和时间表，显著 双盲条件下干扰素生物活性的诱导措施 条件。在这个剂量的rIFN-B中，对乙酰氨基酚是有效的 在促进失明方面，从而消除了对以前使用的 吲哚美辛具有潜在的混杂免疫作用。 如果这项研究的结果是积极的，那么rFIN-B可能会广泛 今后也将作为临床实践性治疗多发性硬化。

This research will determine the efficacy of intramuscular (IM) recombinant human fibroblast interferon (rIFN-B) administered for exacerbating multiple sclerosis (MS) under randomized, double-blinded, placebo controlled conditions. Our previous double-blinded study demonstrated that intrathecal (IT) natural IFN-B was effective in reducing MS exacerbations. The IT route of administration for that study was dictated by the belief that systemic IFN- B did not cross the blood-brain barrier (BBB). However, there is new evidence indicating that systemic IFN-B does cross the BBB which compels assessment of systemically administered interferon in MS. This multicentered study will include 288 patients with active exacerbating MS who will be randomly assigned to receive IM injections of rIFN-B or placebo. Treatments will be performed weekly for 104 weeks. The primary measure of efficacy will be the intergroup difference in the time to progression in disability as measured by the Kurtzke Expanded Disability Scale of at least 1.0 units which persists for six months. Additionally, a number of other important parameters of MS disease activity and patient functional status will be analyzed as secondary outcome measures. Our recently completed Pilot Study determined that 6 x 106 IU administered IM weekly was the ideal dose and schedule of rIFN-B which significantly induced measures of interferon biologic activity under double-blinded conditions. Further at this dosage of rIFN-B, acetaminophen was effective in facilitating blinding, thus obviating the need for previously used indomethacin which had potentially confounding immunologic effects. If the results of this study are positive, then rFIN-B may be widely employed in the future as a practicle clinical too in the treatment of MS.