Open-Label Natalizumab Safety Extension Study

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Natalizumab

Criteria

Inclusion Criteria:

• Must give written informed consent.

• Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803

Exclusion Criteria:

• History of, or available abnormal laboratory results, indicative of any significant disease that would preclude treatment.

• History of severe allergic or anaphylactic reactions or known drug hypersensitivity

• A clinically significant infectious illness within 30 days prior to study entry.