Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis

Treatment tested

• Natalizumab

  Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor

Placebo or sham

• Placebo

Other measures (1)

Inclusion Criteria: * Diagnosis of MS as defined by McDonald et al., criteria # 1-4 * Between the ages of 18 and 55, inclusive * Baseline EDSS score between 0.0 and 5.0, inclusive * Have been treated with GA for at least the 12 months prior to randomization Exclusion Criteria: * Primary progressive, secondary progressive or progressive relapsing MS * MS relapse has occurred within the 50 days prior to randomization * A clinically significant infectious illness * History of, or abnormal lab result indicative of significant disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent or GA for 20 weeks.

The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).