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.
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