At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 404 enrolled
Drug / intervention
BG00002 (natalizumab)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, or C-1803 and a Dosing Suspension Safety Evaluation
In Brief
A Phase 3 clinical trial evaluating BG00002 (natalizumab) for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 404 participants across 63 sites in 2 countries.
Detailed Summary
The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab from interferon beta (IFN-β), glatiramer acetate (GA), or other multiple sclerosis (MS) therapies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Relapsing-Remitting
CountriesCanada, United States
CollaboratorsElan Pharmaceuticals
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
First PostedMar 2006
Primary CompletionDec 2007
Study CompletionFeb 2008
TodayJul 2026
First PostedMar 24, 2006
Enrollment StartMar 1, 2006
Primary CompletionDec 1, 2007
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.3 years ago
Interventions
BG00002 (natalizumab)biological