Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
The purpose of this study is to determine the safety and efficacy of natalizumab in the
 treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis
 (MS). It is hoped that natalizumab will 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.
Inclusion Criteria:

 -  Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001)

 -  Between the ages of 18 and 50, inclusive.

 -  Baseline EDSS score between 0.0 and 5.0, inclusive.

 -  Have experienced at least one relapse within the 12 months prior to randomization.

 -  Cranial MRI scan demonstrating lesion(s) consistent with MS.

 -  Have given written informed consent to participate in the study.

 Exclusion Criteria:

 -  Primary progressive, secondary progressive, or progressive relapsing MS.

 -  MS relapse has occurred,in the opinion of the investigator, within 50 days prior to
 randomization and/or the subject has not stabilized from a previous relapse.

 -  A clinically significant infectious illness within 30 days prior to randomization.

 -  History of, or abnormal laboratory results indicative of any significant cardiac,
 endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,
 gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in
 the opinion of the investigator, would preclude the administration of a recombinant
 humanized antibody immunomodulating agent for 116 weeks.

 -  History of severe allergic or anaphylactic reactions or known drug hypersensitivity.

 -  Unable to perform the Timed 25-foot Walk, 9HPT, and PASAT 3.

 -  Abnormal blood tests performed at the Screening Visit.