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
Maitland, Florida 32751
2183
mi
from 91732
Maitland, FL
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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...
2135
mi
from 91732
Tampa, FL
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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...
648
mi
from 91732
Albuquerque, NM
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Calgary, Alberta
?
mi
from 91732
Calgary,
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2001 Vail Avenue
Charlotte, North Carolina 28207
2103
mi
from 91732
Charlotte, NC
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14561 North Outer 40 Road
Chesterfield, Missouri 63017
1555
mi
from 91732
Chesterfield, MO
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111 South Grant Avenue
Columbus, Ohio 43215
1961
mi
from 91732
Columbus, OH
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Cordova, Tennessee 38018
1601
mi
from 91732
Cordova, TN
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1780
mi
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Cullman, AL
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Farmington Hills, Michigan 48334
1952
mi
from 91732
Farmington Hills, MI
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Fullerton, California 92835
13
mi
from 91732
Fullerton, CA
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Golden Valley, Minnesota 55422
1507
mi
from 91732
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...
95
mi
from 91732
La Jolla, CA
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888 West Bonneville Avenue
Las Vegas, Nevada 89106
216
mi
from 91732
Las Vegas, NV
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2322
mi
from 91732
Miami, FL
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1208
mi
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Round Rock, TX
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Salt Lake City, Utah 84103
570
mi
from 91732
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...
961
mi
from 91732
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...
2429
mi
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Staten Island, NY
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423
mi
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Tucson, AZ
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Westerville, Ohio 43081
1964
mi
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Westerville, OH
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Willow Grove, Pennsylvania 19090
2377
mi
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Willow Grove, PA
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