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

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Collaborator: Elan Pharmaceuticals
• Treatments: Glatiramer Acetate; Natalizumab

Criteria

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.