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

Completed · Phase 3

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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).

Key facts

Study ID

NCT02545868

Run by

Hoffmann-La Roche

People needed

102

Starts

2015-10-27

Expected to finish

2021-09-21

Last updated by the study team

2024-03-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• North Central Neurology Associates — Cullman, Alabama, United States
• Territory Neurology and Research Institute — Tucson, Arizona, United States
• Fullerton Neurology and Headache Center — Fullerton, California, United States
• Scripps Clinic — La Jolla, California, United States
• University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Michigan Institute for Neurological Disorders — Farmington Hills, Michigan, United States
• The Minneapolis Clinic of Neurology — Golden Valley, Minnesota, United States
• Mercy Hospital St. Louis / Mercy Clinic Neurology — Chesterfield, Missouri, United States
• Cleveland Clinic Lou Ruvo; Center for Brain Research — Las Vegas, Nevada, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Staten Island Univ Hospital — Staten Island, New York, United States
• Neurology Associates PA — Hickory, North Carolina, United States
• Ohio Health Research Institute Grant Medical Center — Columbus, Ohio, United States
• MDH Research LLC — Westerville, Ohio, United States
• Abington Neurological Associates — Abington, Pennsylvania, United States
• Neurology Clinic PC — Cordova, Tennessee, United States
• Central Texas Neurology Consultants — Round Rock, Texas, United States
• Rocky Mountain MS Clinic — Salt Lake City, Utah, United States
• Swedish Medical Center — Seattle, Washington, United States
• University of Calgary — Calgary, Alberta, Canada
• University of British Columbia Hospital; Division of Neurology — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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