Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

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.