SAFETY AND TOLERABILITY OF NATALIZUMAB IN SUBJECTS WITH MULTIPLE SCLEROSIS WHO H

那他珠单抗在多发性硬化症患者中的安全性和耐受性

• 批准号: 7376157
• 负责人: HEIDI J CRAYTON
• 金额: $ 2.17万
• 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/7376157
• 关键词: SAFETY; TOLERABILITY; NATALIZUMAB; SUBJECTS; MULTIPLE

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. Natalizumab is being investigated by Biogen Idec Inc. (the sponsor of this research study), in partnership with Elan Pharmaceuticals, Inc., as a possible new treatment for multiple sclerosis (MS). It is hoped that natalizumab may prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS. The purpose of this study is to determine whether natalizumab is safe and well-tolerated in individuals with relapsing-remitting MS over an extended period of time. In addition, Biogen Idec will also evaluate whether people make antibodies (a protein that is made sometimes when a person is exposed to a protein that is not normally found in the body) to natalizumab.

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。 Natalizumab与Elan Pharmaceuticals，Inc。合作，由Biogen Idec Inc.（本研究的赞助商）研究，作为多发性硬化症（MS）的新治疗方法。希望Natalizumab可以防止某些类型的白细胞从血液中移入包括大脑在内的器官，这些人受到自身免疫性疾病的损害（这种疾病（一种人体自身的免疫系统会攻击某些器官）。这些白细胞被认为会引起炎症，从而导致大脑病变（损坏的小区域）。这些病变被认为是MS复发和残疾的原因。这项研究的目的是确定在长时间具有复发率复发的MS的个体中，纳他蛋白单抗是否安全且耐受性良好。此外，Biogen IDEC还将评估人们是否生产抗体（当一个人暴露于通常在体内未发现的蛋白质时产生的蛋白质）。