Status:
COMPLETED
Open-Label Natalizumab Safety Extension Study
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 m...
Eligibility Criteria
Inclusion
- Must give written informed consent.
- Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
1615 Patients enrolled
Trial Details
Trial ID
NCT00276172
Start Date
December 1 2003
End Date
January 1 2006
Last Update
June 22 2009
Active Locations (1)
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1
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, 02142