Natalizumab High Titer Immunogenicity and Safety

A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple Sclerosis

The primary objective of the study was to evaluate the immunogenicity of natalizumab (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E) administered intravenously (IV) to participants with relapsing forms of multiple sclerosis (MS). The secondary objective of this study was to evaluate the safety of natalizumab high titer.

Inclusion Criteria:

• Diagnosis of a relapsing form of MS
• Must fall within the therapeutic indications stated in the locally approved label for natalizumab
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Prior treatment with natalizumab
• Considered by investigator to be immunocompromised
• Other protocol-defined exclusion criteria may apply