A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:3/28/2019
Start Date:August 31, 2011
End Date:November 30, 2022

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A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis

This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy
and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with
relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab
600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the
first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks,
with placebo injections matching interferon beta-1a SC three times per week; or interferon
beta-1a 44 mcg SC injections three times per week (with placebo infusions matching
ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96
weeks. Participants who complete the 96-week double-blind treatment will have an option to
enter a single-group, active-treatment, open-label extension period, providing they fulfill
the eligibility criteria.


Inclusion Criteria:

- Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria
(2010)

- At least 2 documented clinical attacks within the last 2 years prior to screening or
one clinical attack in the years prior to screening (but not within 30 days prior to
screening)

- Neurologic stability for greater than or equal to (>=) 30 days prior to both screening
and baseline

- Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Exclusion Criteria:

- Primary progressive multiple sclerosis

- Disease duration of more than 10 years in participants with EDSS less than or equal to
(<=) 2.0 at screening

- Contraindications for MRI

- Known presence of other neurological disorders which may mimic multiple sclerosis

- Pregnancy or lactation

- Requirement for chronic treatment with systemic corticosteroids or immunosuppressants
during the course of the study

- History of or currently active primary or secondary immunodeficiency

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies

- Active infection, or history of or known presence of recurrent or chronic infection
(e.g., hepatitis B or C, human immunodeficiency virus [HIV], syphilis, tuberculosis)

- History of progressive multifocal leukoencephalopathy

- Contraindications to or intolerance of oral or iv corticosteroids

- Contraindications to Rebif or incompatibility with Rebif use
We found this trial at
56
sites
1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
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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...
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152 East Kinderton Way
Advance, North Carolina 27006
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Albuquerque, New Mexico 87131
(505) 277-0111
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Atlanta, Georgia 30309
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1115 Ronald Reagan Parkway
Avon, Indiana 46123
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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3855 Avenida Rivadavia
Buenos Aires, C1204AAD
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Burlington, Vermont 05405
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Cedarhurst, New York
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Charlotte, North Carolina 28210
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1010 Edgehill Road North
Charlotte, North Carolina 28207
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420 East Superior Street
Chicago, Illinois 60611
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Cincinnati, Ohio 45219
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Clinton Township, Michigan 48035
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Des Moines, IA
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East Providence, Rhode Island 02915
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Evanston, Illinois 60201
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Farmington Hills, Michigan 48334
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Golden Valley, Minnesota 55422
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7000 Fannin Street
Houston, Texas 77030
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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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Lubbock, Texas 79410
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Maitland, Florida 32751
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Melbourne, Florida 32901
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Miami, Florida
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Newport Beach, California 92663
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Northbrook, Illinois 60062
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Oklahoma City, Oklahoma 73104
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Pasadena, California 91105
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Pembroke Pines, Florida
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5501 Old York Road
Philadelphia, Pennsylvania 19141
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Phoenix, Arizona 85004
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300 Halket St
Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97225
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10800 Magnolia Avenue
Riverside, California 92505
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Sacramento, California 95816
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2315 Stockton Boulevard
Sacramento, California 95817
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3009 North Ballas Road
Saint Louis, Missouri 63131
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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San Francisco, California 94143
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Scarborough, Maine 04074
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19875 Southwest 65th Avenue
Tualatin, Oregon 97062
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