Multiple Sclerosis Clinical Trial

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

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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).

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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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

102

Study ID:

NCT02545868

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 22 Locations for this study

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North Central Neurology Associates
Cullman Alabama, 35058, United States
Territory Neurology and Research Institute
Tucson Arizona, 85704, United States
Fullerton Neurology and Headache Center
Fullerton California, 92835, United States
Scripps Clinic
La Jolla California, 92037, United States
University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center
Miami Florida, 33136, United States
University of South Florida
Tampa Florida, 33612, United States
Michigan Institute for Neurological Disorders
Farmington Hills Michigan, 48334, United States
The Minneapolis Clinic of Neurology
Golden Valley Minnesota, 55422, United States
Mercy Hospital St. Louis / Mercy Clinic Neurology
Chesterfield Missouri, 63017, United States
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas Nevada, 89106, United States
University of New Mexico
Albuquerque New Mexico, 87131, United States
Staten Island Univ Hospital
Staten Island New York, 10306, United States
Neurology Associates PA
Hickory North Carolina, 28602, United States
Ohio Health Research Institute Grant Medical Center
Columbus Ohio, 43214, United States
MDH Research LLC
Westerville Ohio, 43082, United States
Abington Neurological Associates
Abington Pennsylvania, 19001, United States
Neurology Clinic PC
Cordova Tennessee, 38018, United States
Central Texas Neurology Consultants
Round Rock Texas, 78681, United States
Rocky Mountain MS Clinic
Salt Lake City Utah, 84103, United States
Swedish Medical Center
Seattle Washington, 98104, United States
University of Calgary
Calgary Alberta, T2N 2, Canada
University of British Columbia Hospital; Division of Neurology
Vancouver British Columbia, V6T 2, Canada
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How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

102

Study ID:

NCT02545868

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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