A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
- Autoimmune Disorder
- Multiple Sclerosis (MS)
Completed
- Abington
- Albuquerque
- Calgary
- Columbus
- Cullman
- Farmington Hills
- Fullerton
- Hickory
- Las Vegas
- Memphis
- Miami
- Minneapolis
- New York
- Round Rock
- Salt Lake City
- San Diego
- Seattle
- St. Louis
- Tampa
- Tucson
- Vancouver
- Westerville
NCT02545868 2015-001357-32 BN29739
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).
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
- 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
- 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
For the latest version of this information please go to www.forpatients.roche.com