结合试验雌三醇+ Glatimer复发缓和多发性硬化的醋酸(i7 - 2.002)

文摘

目的:确定口腔治疗的效果与复发的女性怀孕激素雌三醇汇款多发性硬化症。背景:怀孕是一段相对防止复发。雌三醇是一种雌激素,会增加高血清水平在过去一半的怀孕。雌激素治疗的有利影响,包括雌三醇,包括抗炎和神经保护机制模型。小交叉试验之前显示的白质增强病变减少80%每月的核磁共振成像。设计/方法:这是一个随机、双盲、多中心、安慰剂对照试验口服雌三醇(1:1)8毫克/天名RRMS女性,年龄18-50年。雌三醇是一个附加疗法。因此,所有科目开始glatimer乙酸注射2个月内或更少的随机化雌三醇与安慰剂相结合。治疗持续时间是2年。主要终点是复发年率。 Other endpoints included MSFC, EDSS, and MRI measures of white matter lesion activity. RESULTS: Baseline characteristics: 164 subjects from 15 sites across the U.S. were randomized with a mean age of 37.5 and mean disease duration of 3.0 years. 99.4% had at least one relapse in the preceding 24 months, with 29.4% having at least one enhancing lesion on a single screening MRI. The mean EDSS score was 2.2. The database will be locked and unblinded analyses will be done by the time of presentation. Results from primary and other outcomes will be shown as well as serum estriol levels and safety data. CONCLUSIONS: Effects of treatment of RRMS women with a dose of estriol to induce a pregnancy level in serum will be discussed in the context of future development of estriol as a novel treatment in MS, and insights in understanding disease protection during pregnancy will be explored.

披露:Voskuhl博士已经收到个人活动与合成生物制剂公司补偿。Voskuhl博士从加州大学洛杉矶分校获得了执照费支付。Voskuhl博士收到合成生物制剂,研究支持和玉米生物。王博士没有披露。吴博士没有披露。Sicotte博士没有披露。贝茨博士已经收到个人活动与神经科学Teva)补偿和Idec,海狸博士没有披露。Corboy博士已经收到个人补偿活动过程作为一个演讲者,Celgene公司治疗,神经科学Teva)和诺华作为一个演讲者。Corboy博士已经收到了来自诺华制药研究支持,BioMS,礼来公司& Co ., Celgene公司疗法和免疫耐受的网络。交叉博士已经收到个人活动与补偿Idec, Genzyme公司,葛兰素史克,Inc .,霍夫曼-罗氏公司,Teva神经科学、诺华、Questcor。交叉已收到博士研究支持从霍夫曼-罗氏公司和赛诺菲-安万特制药公司。Dhib-Jalbut博士已经收到个人活动与Serono补偿和诺华作为顾问。 Dr. Ford has received personal compensation for activities with Teva Neuroscience, Biogen Idec, and Novartis. Dr. Ford has received research support from Acorda Therapeutics, Biogen Idec, Genzyme Corp., Novartis, Ono Pharmaceutical, Roche Diagnostics Corp., Sanofi-Aventis Pharmaceuticals Inc., EMD Serono, and Teva Neuroscience. Dr. Giesser's family hold stock and/or stock options in Biogen Idec and Pfizer Inc. Dr. Giesser has received research support from AVAcore Technologies. Dr. Jacobs has received personal compensation for activities with Questcor Diagnostics, and Teva Neuroscience. Dr. Lynch has received research support from Novartis, Biogen Idec, Teva Neuroscience, Genzyme Corp., Genentech Inc., Berlex, Cognition Pharmaceuticals, UCB Pharmaceuticals, Serono Inc., and Cephalon. Dr. Pachner has received personal compensation for activities with Biogen Idec, Novartis, Pfizer Inc., Sanofi-Aventis Pharmaceuticals Inc., Genzyme Corp., and EMD-Serono. Dr. Pachner has received research support from Hoffman-LaRoche, and Sanofi-Aventis Pharmaceuticals Inc. Dr. Racke has received personal compensation for activities with Biogen Idec, Revalesio, and Novartis. Dr. Racke has received personal compensation in an editorial capacity for JAMA Neurology and the Journal of Neuroimmunology. Dr. Racke has received research support from Diogenix. Dr. Ratchford has received personal compensation for activities with Biogen Idec, Genzyme Corporation, GW Pharmaceuticals, and Diogenix. Dr. Ratchford has received research support from Novartis, Biogen Idec, and Sun Pharmaceuticals. Dr. Reder has received personal compensation for activities with Bayer, Biogen Idec, Genentech, Inc., Genzyme Corporation, Merck & Co., Inc., Novartis, Questcor, Serono, Teva Neuroscience, Caremark, Multiple Sclerosis Society of Canada, National Multiple Sclerosis Society, State of Illinois, and State of Indiana. Dr. Reder has received personal compensation in an editorial capacity for Medlink/Neurobase. Dr. Rose has received research support from Teva Neuroscience, and Biogen Idec. Dr. Wingerchuk has received research support from Genentech, Inc., Genzyme Corporation, Alexion, and TerumoBCT. Dr. Burnett has received personal compensation for activities with Biogen Idec, Genzyme Corporation, Novartis, Serono Inc., Pfizer Inc., and Teva Neuroscience. Dr. Tseng has nothing to disclose. Dr. Elashoff has nothing to disclose.