EXTENSION STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF NATALIZUMAB FOLLOWING

这个子项目是众多研究子项目之一

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.