A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER

随机、双盲、安慰剂对照、平行组、多中心研究

• 批准号: 7376119
• 负责人: HEIDI J CRAYTON
• 金额: $ 1.34万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376119
• 关键词: RANDOMIZED; DOUBLE; BLIND; PLACEBO; CONTROLLED

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of this study are to determine whether adding natalizumab to the standard regimen of Avonex, when compared with adding placebo, is effective in: -reducing the rate of clinical relapses at 1 year and -slowing the progression of disability at 2 years, as measured by: at least a 1.0 point increase on the Expanded Disability Status Scale (EDSS) from baseline EDSS>= 1.0, that is sustained for 12 weeds or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The secondary objectives of this study are: - at 1 year, to determine whether adding natalizumab to the standard regimen of Avonex when compared with adding placebo, is effective in: -reducing the number of gadolinium-enhancing lesions on brain magnetic resonance imaging (MRI) scans; -reducing the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans; and -increasing the proportion of relapse-free subjects. -at 2 years, to determine whether adding natalizumab to the standard regimen of Avonex, when compared with adding placebo, is effective in: -reducing the rate of clinical relapses; -attenuating the increase in T1 hypointense lesion number on brain MRI scans; - attenuating the increase in T2 hyperintense lesion volume on brain MRI scans; - slowing the progression of disability, as determined by the change in the Multiple Sclerosis Functional Composite Scale (MSFC) in each treatment group. The MSFC consists of the Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT), and 3-Second Paced Auditory Serial Addition Test (PASAT 3); and dtermined after at least 1200 total patient-years of observation, and after all subjects remaining in the study have completed at least the Week 24 visit of the protocol. determined after at least 75% of subjects have been studied for 120 weeks.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这项研究的主要目的是确定与添加安慰剂相比，在Avonex的标准方案中添加Natalizumab是否有效地在： - 还原1年时的临床复发速率，并在2年中降低残疾的进展，以下是：至少在：至少在：至少在12点上估计的是：至少在12个杂志上（EDS）估计1.0点，以1.0的范围= 1.0> 1.0> 1.0> 1.0> 1. eds inseline Eds = 1.0> 1.0> 1.0> 1.0> 1.0> 1.0> 1.0> 1.0> 1.0。从基线EDSS = 0的EDSS增加了1.5点，该EDSS = 0持续了12周。这项研究的次要目标是： - 1年，确定与添加安慰剂相比，是否在Avonex的标准方案中添加Natalizumab是否有效： - 降低对脑磁共振成像（MRI）扫描的Gadolinementage for -natize to; - 还原大脑MRI扫描中新的或新的T2高强度病变的数量；并提高无复发受试者的比例。 - 在2年后，确定与添加安慰剂相比，在Avonex的标准方案中添加Natalizumab是否有效： - 降低临床复发率； - 促进脑MRI扫描中T1高端病变的增加； - 减弱了脑MRI扫描中T2高强度病变体积的增加； - 减慢残疾的进展，这取决于每个治疗组中多发性硬化功能复合量表（MSFC）的变化。 MSFC由定时步行，9孔PEG测试（9HPT）和3秒节奏的听觉串行添加测试（PASAT 3）组成；并在至少1200个患者年观察年之后进行了D术，并且在研究中剩下的所有受试者之后，至少已经完成了第24周的访问。在至少75％的受试者中研究了120周后确定。