NCT00516893

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	BG00002-E (natalizumab high titer)

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-10-01
• Completion: 2007-12-01
• First posted: 2007-08-16
• Last updated: 2014-05-15
• Results posted: 2009-08-13

Locations

13 sites across 1 country: United States