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

NCT02545868

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Multiple Sclerosis, Relapsing-Remitting

Interventions: 23-PPV, 13-PCV Booster, Influenza Vaccine, KLH, OCR

Countries: United States, Canada

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (22)

Cullman, Alabama, United States
Tucson, Arizona, United States
Fullerton, California, United States
La Jolla, California, United States
Miami, Florida, United States
Tampa, Florida, United States
Farmington Hills, Michigan, United States
Golden Valley, Minnesota, United States
Chesterfield, Missouri, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Staten Island, New York, United States
Hickory, North Carolina, United States
Columbus, Ohio, United States
Westerville, Ohio, United States
Abington, Pennsylvania, United States
Cordova, Tennessee, United States
Round Rock, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada