Relapsing-Remitting Multiple Sclerosis
Conditions
Interventions
Participants will receive natalizumab 300 mg SC Q4W for 48 weeks.
Sponsors
Amir Hadi Maghzi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Must have had a diagnosis of RRMS, as defined by the revised 2017 McDonald's criteria. All other possible neurologic diagnoses must have been reasonably excluded by means of laboratory and/or imaging studies, in the opinion of the Investigator. - Must have had an EDSS score between 0.0 and 5.5, inclusive. - Must have had screening MRI or documentation of an MRI within the participant's medical record within 12months of the Screening Visit that revealed 3 or more T2 hyperintense lesions consistent with MS. - Was born in Japan, and biological parents and grandparents were of Japanese origin.
Exclusion criteria
Exclusion criteria: - Evidence of current SARS-CoV-2 infection within 14 days prior to Screening, between Screening and Baseline Visit, or at Baseline Visit, including but not limited to a fever (temperature > 37.5 degrees Celsius), new and persistent cough, breathlessness, or loss of taste and/or smell. - Have close contact within 14 days prior to Day 1 with a SARS-CoV-2 positive individual. - Diagnosis of primary progressive MS or secondary progressive MS. - An MS exacerbation (relapse) within 30 days prior to enrollment or, in the opinion of the Investigator, the participant not having stabilized from a previous relapse prior to enrollment (Day 1). - The participant is unable to have a brain MRI scan (e.g., a participant with a metal clip to repair a cerebral aneurysm). - Previous exposure to natalizumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative number of new active lesions on Week 24 brain MRI scans. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Cumulative number of new active lesions on Week 48 brain MRI scans. - Proportion of participants with any new active lesions on Week 24 and Week 48 brain MRI scans. - Change from baseline in number of gadolinium-enhancing lesions at Week 24 and Week 48. - The number of nonenhancing new or newly enlarging T2 hyperintense lesions at Week 24 and Week 48. - The number of new T1 hypointense lesions at Week 24 and Week 48. - Annualized Relapse Rate (ARR). - Proportion of relapse-free participants at Week 24 and Week 52. - VAS assessing the participant's global impression of their well-being at Week 24 and Week 48. - Incidence of treatment-emergent AEs and SAEs. - Anti-JCV antibody. - Anti-natalizumab antibodies. - Change in EDSS score from Baseline. - Serum natalizumab concentrations. - Alpha-4-integrin saturation and serum soluble VCAM-1 concentrations. | — |
Contacts
Public ContactBiogen Japan Medical Information
Biogen Japan Ltd.
Outcome results
None listed