A Phase 3 interventional study of Natalizumab in Multiple Sclerosis, sponsored by Biogen. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-22.
Sponsored by Biogen · Phase 3, Interventional, and Treatment
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 1,615 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Open-label natalizumab
Drug: Natalizumab
Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months
Also known as: Tysabri
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.
Time frame: Month 24
EDSS scores and assessments of relapse.
Time frame: Month 24
This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Biogen