CompletedPhase 3

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

United States102 participantsStarted 2015-10-27

Plain-language 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).

Who can participate

Age range18 Years – 55 Years

SexALL

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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

What they're measuring

Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine

Timeframe: 8 weeks after TT vaccine

Trial details

NCT IDNCT02545868

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-02-14

Results submitted2018-02-13