drugset / Trial / NCT00516893

Natalizumab High Titer Immunogenicity and Safety

NCT00516893

Phase 2 Completed 113 enrolled Biogen Elan Pharmaceuticals · collab
NaSingle-groupOpen-label

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.

Timeline

Start
2006-10
Primary completion
2007-10
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject natalizumab Monoclonal antibody 300 mg Intravenous

Indications