Summary:
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose of ocrelizumab.
Criteria:- Diagnosis of relapsing multiple sclerosis (RMS).
- At least two documented clinical attacks within the last 2 years prior to screening, or one clinical attack in the year prior to screening. No relapse 30 days prior to screening and at baseline.
- Participants must be neurologically stable for at least 30 days prior to randomization and baseline.
- Expanded disability status scale (EDSS), at screening and baseline, from 0 to 5.5 inclusive.
- Documented MRI of brain with abnormalities consistent with MS prior to screening.
- Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization.
- For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods.
- For female participants, without reproductive potential may be enrolled if post-menopausal, unless receiving a hormonal therapy for her menopause or if surgically sterile
Qualified Participants May Receive:
Compensation up to $1,440.00 over the study length (27 months).