NCT00276172

Open-Label Natalizumab Safety Extension Study

An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,615 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the safety and the immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV) to subjects with multiple sclerosis (MS) who have completed natalizumab Studies C-1801, C-1802, or C-1803.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Natalizumab	Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months

Timeline

• Start date: 2003-12-01
• Primary completion: 2005-10-01
• Completion: 2006-01-01
• First posted: 2006-01-13
• Last updated: 2009-06-22

Locations

1 site across 1 country: United States