IM RECOMBINANT BETA INTERFERON AS TREATMENT FOR MS

本研究将确定肌内（IM）重组 人成纤维细胞干扰素（rIFN-B）给药用于加重多发性骨髓瘤 在随机、双盲、安慰剂对照下， 条件 我们以前的双盲研究表明，鞘内（IT） 天然IFN-B可有效减少MS恶化。 IT之路 该研究的给药是由系统性IFN-γ B不能穿过血脑屏障（BB B）。 然而，有新的 有证据表明，系统性IFN-B确实穿过BBB， MS患者全身应用干扰素的评估 这项多中心研究将纳入288例活动性急性加重患者， MS患者将被随机分配接受IM注射rIFN-B或 安慰剂 治疗将每周进行一次，持续104周。 疗效的主要指标是组间差异， 根据Kurtzke扩展量表测量的至残疾进展时间 残疾量表至少1.0个单位，持续6个月。 此外，MS疾病活动的许多其他重要参数 患者功能状态将作为次要结局进行分析 措施 我们最近完成的初步研究确定， IM每周一次是rIFN-B的理想剂量和时间表， 双盲条件下干扰素生物活性的诱导测量 条件 此外，在此剂量的rIFN-B，对乙酰氨基酚是有效的 在促进盲，从而避免了需要以前使用的 吲哚美辛具有潜在的免疫学混淆作用。 如果这项研究的结果是积极的，那么rFIN-B可能广泛 将来也可以作为临床上治疗多发性硬化症的一种实用方法。

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.