TY -的T1 -口服Cladribine延迟时间转换为临床明确患者的女士第一次脱髓鞘事件:顶线从女士第三阶段甲骨文研究的结果(P07.114) JF -神经学乔-神经病学SP - P07.114 LP - P07.114六世- 80 - 7补充AU -托马斯Leist AU -吉安卡洛Comi AU -布鲁斯克里族盟-帕特丽夏Coyle AU -马克·弗里德曼盟-汉斯·哈东盟-帕特里克V首页ermersch AU -阿米莉亚Orejudos盟娜塔莉Lachenal AU -马修Scaramozza Y1 - 2013/02/12 UR - //www.ez-admanager.com/content/80/7_Supplement/P07.114.abstract N2 -目的:评价口服Cladribine对时间的影响转化为临床明确多发性硬化症(CDMS)患者第一次临床脱髓鞘的事件。背景:药物与疾病早期治疗修改(诊断)患者单个事件延迟进展CDMS脱髓鞘。鉴于其证明效力在清晰的研究中,cladribine评估患者第一次脱髓鞘事件延迟级数的探测器每2005麦当劳标准(或女士)在ORACLE女士审判。96周的双盲期间接近完成cladribine发展项目时停止。结果从这个治疗期。设计/方法:患者18-55岁一个脱髓鞘事件,祝辞= 2临床沉默T2脑损伤和eds 0 - 5.0, 5.25毫克/公斤cladribine被随机分配比,3.5毫克/公斤cladribine或安慰剂。主要终点是时间从随机化CDMS转换,由一个独立的审判委员会确认。结果:616名患者被随机分配接受研究药物。Cladribine治疗组取得了显著延迟时间的探测器转换,与风险减少61.9%(危险比= 0.381)和67.3%(危险比= 0.327)Cladribine 5.25和3.5毫克/公斤组分别相对于安慰剂(p & lt;0.0001)。15%、13%和35%的患者在5.25毫克/公斤,3.5毫克/公斤和安慰剂组分别转换为探测器。治疗cladribine cladribine 5.25和3.5毫克/公斤也显著延迟时间转换麦当劳女士(2005)与安慰剂相比(p & lt; 0.0001). Mean number of T1 Gd+, active T2, and combined unique lesions/patient/scan were significantly reduced, with lesion reductions of 73.14 - 90.51% and 78.84 – 89.25% for cladribine 5.25 and 3.5mg/kg groups respectively, relative to placebo (p<0.001).CONCLUSIONS: Oral cladribine treatment over two years significantly reduced the risk of new attacks and new MRI activity in patients with a first clinical demyelinating event.Supported by: Merck Serono S.A. – Geneva, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany.Disclosure: Dr. Leist has received personal compensation for activities with EMD Serono, Teva Neuroscience, Biogen, Bayer, and Pfizer as a consultant. Dr. Leist has received research support from EMD Serono, Teva Neuroscience, Bayer, ONO, Novartis Daishi, Acorda. Dr. Comi has received personal compensation for activities with Novartis, Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Inc., Merck Serono, and Bayer Schering. Dr. Cree has received personal compensation for activities with Biogen Idec, EMD Serono, Genzyme Corporation, Novartis, Sanofi-Aventis Pharmaceuticals, Inc., and Teva Neuroscience. Dr. Coyle has received personal compensation for activities with Acorda Therapeutics, Bayer, Biogen Idec, Genentech, Inc., Novartis, Pfizer Inc, Questcor, Roche Diagnostics Corporation, Sanofi-Aventis Pharmaceuticals Corporation, and Teva Neuroscience. Dr. Coyle has received personal compensation in an editorial capacity for NEURA. Dr. Coyle has received research support fromActelion, EMD Serono, and Novartis. Dr. Freedman has received personal compensation for activities with Bayer, Biogen Idec, Teva, Merck Serono, Novartis, Sanofi, and Celgene. Dr. Freedman's institution has received research support from Bayer Healthcare and Genzyme. Dr. Hartung has received personal compensation for activities with Biogen Idec, Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Inc., Bayer, Novartis, and Merck Serono. Dr. Vermersch has received personal compensation for activities with Biogen Idec, Sanofi-Aventis Pharmaceuticals, Inc., Bayer, Novartis, Merck Serono, GlaxoSmithKline, Inc., and Almirall. Dr. Vermersch has received research support from Biogen Idec, Sanofi-Aventis Pharmaceuticals, Inc., Bayer, and Merck Serono. Dr. Orejudos has received personal compensation for activities with EMD Serono as an employee. Dr. Lachenal is an employee of Merck Serono. Dr. Scaramozza has received personal compensation for activities with Pfizer research, employed by inVentiv Clinical Solutions, Inc. as an onsite consultant.Thursday, March 21 2013, 2:00 pm-7:00 pm ER -