Open-Label Natalizumab Safety Extension Study
- Registration Number
- NCT00276172
- Lead Sponsor
- Biogen
- 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 multiple sclerosis (MS) who have completed natalizumab Studies C-1801, C-1802, or C-1803.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1615
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Natalizumab Natalizumab Open-label natalizumab
- Primary Outcome Measures
Name Time Method The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed. Month 24
- Secondary Outcome Measures
Name Time Method EDSS scores and assessments of relapse. Month 24
Trial Locations
- Locations (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