The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).
This is a a dose and frequency (but not route of administration) blinded, prospective, randomized, dose-ranging study in patients with RRMS who have received natalizumab for at least 12 months according to the local prescribing guidelines. The study will explore dosing of natalizumab by subcutaneous and intravenous routes. Participants will be randomly assigned to 1 of 6 dosing regimens, blinded to natalizumab dose, but not route, for 60 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
290
natalizumab for IV Infusion
natalizumab for Subcutaneous Injection
Intravenous placebo to natalizumab
Cumulative Number of Combined Unique Active Lesions
Cumulative number of combined unique active lesions (sum of the number of new gadolinium (Gd)-enhancing lesions and new or newly enlarging T2 hyperintense lesions not associated with Gd-enhancement on T1 weighted scans) based on brain magnetic resonance imaging (MRI) scans Up to Week 60.
Time frame: Up to Week 60
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Subcutaneous placebo to natalizumab
Research Site
Brasschaat, Belgium
Research Site
Liège, Belgium
Research Site
Overpelt, Belgium
Research Site
Wilrijk, Belgium
Research Site
Amiens, France
Research Site
Besançon, France
Research Site
Bron, France
Research Site
Lille, France
Research Site
Montpellier, France
Research Site
Nantes, France
...and 54 more locations