Open-Label Natalizumab Safety Extension Study

Completed · Phase 3

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00276172

Run by

Biogen

People needed

1615

Starts

2003-12-01

Expected to finish

2006-01-01

Last updated by the study team

2009-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must give written informed consent.
• Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803

You may not qualify if…

• 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.

Where it is running

• Performed at only C-1801, C-1802, and C-1803 sites globally. No general public enrollment. Biogen Idec is located in — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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