EXTENSION STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF NATALIZUMAB FOLLOWING

评估那他珠单抗安全性和耐受性的扩展研究如下

• 批准号: 7608331
• 负责人: HEIDI J CRAYTON
• 金额: $ 0.89万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608331
• 关键词: Antibodies; Blood Tests; Computer Retrieval of Information on Scientific Projects Database; Early Diagnosis; Exposure to; Funding; Grant; Hypersensitivity; Institution; Interferons; JC Virus; Methodology; Monitor; Neurologic; Population; Purpose; Research; Research Personnel; Resources; Risk; Safety; Source; Symptoms; Testing; Tysabri; United States National Institutes of Health; natalizumab

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 purpose of this study is to study the safety and tolerability of Natalizumab (Tysabri) in subjects with RRMS. Primary Objective: To further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity and immungenicity following re-exposure to natalizumab, and confirming the safety of switching from IFN ¿, GA, or other MS therapies to Natalizumab. Secondary Objectives: o The feasibility of a methodology for early detection and differentiation of PML from MS in subjects who develop new neurological symptoms or signs while on natalizumab therapy. o Whether serial blood testing can be used to monitor the presence of JC virus (JCV) in the MS population. o An approach to testing for persistent anti-natalizumab antibodies.

该副本是使用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。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。列出的机构是 对于中心，这是调查员的机构。 这项研究的目的是研究Natalizumab（Tysabri）在患有RRMS受试者中的安全性和耐受性。 主要目标： 为了进一步评估Natalizumab单一疗法的安全性，通过评估重新暴露于Natalizumab后的超敏反应和免疫性的风险，并确认从IFN？，GA或其他MS疗法切换到Natalizumab的安全性。 次要目标： o在Natalizumab治疗期间出现新的神经系统症状或体征的受试者中，PML早期检测和分化的方法的可行性。 o是否可以使用连续血液测试来监测MS种群中JC病毒（JCV）的存在。 o测试持续性抗纳他蛋白单抗抗体的方法。