Multiple Sclerosis Clinical Trial
Natalizumab High Titer Immunogenicity and Safety
Summary
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.
Eligibility Criteria
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
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There are 13 Locations for this study
Washington District of Columbia, 20007, United States
Maitland Florida, 32751, United States
Miami Florida, 33136, United States
Atlanta Georgia, 30327, United States
Farmington Hills Michigan, 48334, United States
Buffalo New York, 14203, United States
New York New York, 10003, United States
Charlotte North Carolina, 28207, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15212, United States
Dallas Texas, 75214, United States
Round Rock Texas, 78681, United States
Milwaukee Wisconsin, 53215, United States
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