% 0期刊文章%一个劳拉Balcer迭戈Cadavid % %一个史蒂文Galetta % Orhan Aktas % Tjalf Ziemssen %一个骰子游戏Vanopdenbosch %一个福克赫尔穆特•Butzkueven % Ziemssen % Luca Massacesi %一个易建联柴% Lei徐%的斯蒂芬妮·弗里曼% T功效分析Anti-LINGO-1单克隆抗体在急性视神经炎BIIB033:更新试验(P7.202) % D J神经病学2015% % P P7.202 % V 84% N % X 14补充目的:确定Anti-LINGO-1抗体的功效BIIB033在受试者第一集急性视神经炎(AON)。首页背景:在怡安脱髓鞘和轴突损伤通常会导致永久性的结构性和功能性视觉赤字。尽管皮质类固醇治疗可以加速自然痊愈的速度,没有修复治疗可以减少怡安的后遗症。LINGO-1 CNS-specific膜糖蛋白,抑制少突细胞分化和髓鞘形成。BIIB033是一个完整的人单克隆抗体,选择性地对抗LINGO-1, remyelination的临床前模型是有效的,被发现是安全的和良好的耐受性在第一阶段的研究。设计/方法:更新(NCT01721161)是一个持续的、随机、双盲、安慰剂对照,与这些相应平行的组织研究在健康受试者第一集的单边怡安(第四大剂量甲基强的松龙治疗随机化之前)。(18 - 55岁)的受试者随机1:1接受100毫克/公斤BIIB033 IV或安慰剂每隔4周(6总剂量)。每隔4周所有关键评估疗效端点24周从随机化,包括:延迟的视神经传导以细致的视觉诱发电位(主要终点);视网膜神经纤维层厚度来衡量spectral-domain光学相干断层扫描(SD-OCT);视网膜神经节细胞层的厚度/视网膜内网状层测量SD-OCT分割,从基线测量和低对比度变化信敏度斯隆图表。 RESULTS: Eighty-two subjects were randomized to receive BIIB033 or placebo. Detailed descriptions of the efficacy assessments in RENEW will be presented. CONCLUSIONS: Results from the RENEW study will provide evidence for the efficacy of BIIB033 in improving recovery from AON when dosing starts within 28 days of disease onset. Study Supported by: Biogen IdecDisclosure: Dr. Cadavid has received personal compensation for activities with Biogen Idec as an employee. Consultant/advisor for Biogen Idec, Genzyme, Vaccinex, Dr. Galetta has received personal compensation for activities with Biogen Idec, Genzyme, and Vaccinex. Dr. Aktas has received personal compensation for activities with Bayer, Biogen Idec, Genzyme, Novartis, Teva Neuroscience, and Medimmune as an advisor. Dr. Ziemssen has nothing to disclose. Dr. Vanopdenbosch has received personal compensation for activities with Biogen Idec, Genzyme Corporation, Novartis, and Merck Serono. Dr. Butzkueven has received personal compensation for activities with Novartis, Merck Serono, and Biogen Idec as a consultant and/or advisor. Dr. Ziemssen has received personal compensation for activities with Alimera Sciences, Inc., Allergan, Inc., Bayer Healthcare, and Novartis, Dr. Massacesi has received research support from Biogen Idec and Genzyme. Dr. Chai has received personal compensation for activities with Biogen Idec as en employee. Dr. Xu has received personal compensation for activities with Biogen Idec as an employee. Dr. Freeman has received personal compensation for activities with Biogen Idec as an employee.Thursday, April 23 2015, 2:00 pm-6:30 pm %U