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



Status:Active, not recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:2/17/2019
Start Date:October 27, 2015
End Date:December 13, 2022

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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

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).


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
We found this trial at
22
sites
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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Calgary, Alberta
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Calgary,
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2001 Vail Avenue
Charlotte, North Carolina 28207
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Charlotte, NC
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14561 North Outer 40 Road
Chesterfield, Missouri 63017
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Chesterfield, MO
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111 South Grant Avenue
Columbus, Ohio 43215
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Columbus, OH
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Cordova, Tennessee 38018
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Cordova, TN
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Cullman, AL
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Farmington Hills, Michigan 48334
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Farmington Hills, MI
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Fullerton, California 92835
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Fullerton, CA
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Golden Valley, Minnesota 55422
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Golden Valley, MN
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10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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La Jolla, CA
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888 West Bonneville Avenue
Las Vegas, Nevada 89106
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Las Vegas, NV
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Maitland, Florida 32751
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Maitland, FL
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Miami, FL
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Round Rock, TX
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Salt Lake City, Utah 84103
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Salt Lake City, UT
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Seattle, WA
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475 Seaview Ave
Staten Island, New York 10305
(718) 226-9000
Staten Island University Hospital Staten Island University Hospital is a 714-bed, specialized teaching hospital located...
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Staten Island, NY
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Tucson, AZ
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Westerville, Ohio 43081
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Westerville, OH
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Willow Grove, Pennsylvania 19090
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Willow Grove, PA
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