A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis

This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid [TT], 23-valent pneumococcal polysaccharide vaccine [23-PPV], influenza vaccine, and keyhole limpet hemocyanin [KLH]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).
Phase 3
Neuroscience - Multiple Sclerosis, Neuroscience
James Bowen, MD
Lauren Lennox
Inclusion Criteria:
  • Diagnosis of RMS in accordance with the revised McDonald criteria
  • Received at least 1 previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap)
  • Expanded disability status scale (EDSS) at baseline from 0 to 5.5 points, inclusive
  • For sexually active participants with reproductive potential, use of reliable means of contraception
Exclusion Criteria:
  • Contraindications for or intolerance to oral or intravenous corticosteroids, including intravenous methylprednisolone, according to the country label
  • Known presence of other neurologic disorders
  • Treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis (MS)

Lauren Lennox