A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
Sponsor:
Brief Summary:
efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV)
infusion every 24 weeks in participants with PPMS, in comparison to the approved 600 mg dose
of ocrelizumab.
Criteria
– Diagnosis of primary progressive multiple sclerosis (PPMS).
– Expanded disability status scale (EDSS) score at screening and baseline, from 3 to 6.5
inclusive.
– Score of >/= to 2.0 on the Functional Systems scale for the pyramidal system that was
due to lower extremity findings.
– 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.
– Participants must be neurologically stable for at least 30 days prior to randomization
and baseline.
– Disease duration from the onset of MS symptoms, less than 15 years in participants
with an EDSS score at screening >5.0, less than 10 years in participants with an EDSS
score at screening
Locations
- University of California Irvine, Irvine, California, United States, 92697
- University of California Davis Medical Center, Sacramento, California, United States, 95817
- University of California San Francisco, San Francisco, California, United States, 94117
- Stanford University Medical Center; Stanford Neuroscience Health Center, Stanford, California, United States, 94305
- Los Angeles Biomedical Research Institute at Harbor-UCLA, Torrance, California, United States, 90502
