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

  • Multiple Sclerosis (MS)
Trial Status:

Completed

This trial runs in
Countries
  • Canada
  • United States
Trial Identifier:

NCT02545868 2015-001357-32 BN29739

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid [TT]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine [23-PPV] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine [13-PCV], influenza vaccine, keyhole limpet hemocyanin [KLH]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02545868 , BN29739 , 2015-001357-32 Trial Identifier
      23-PPV, 13-PCV Booster, Influenza Vaccine, KLH, OCR, TT Vaccine Treatments
      Multiple Sclerosis, Relapsing-Remitting Condition
      Official Title

      A Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple Sclerosis

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 55 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Diagnosis of RMS in accordance with the revised McDonald criteria
      • Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap)
      • Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive
      • For sexually active female participants of reproductive potential, use of reliable means of contraception
      Exclusion Criteria
      • Contraindications for or intolerance to oral or IV corticosteroids, including IV 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

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