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:September 20, 2011
End Date:November 29, 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).


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 patients with EDSS score less than or equal
to (
- 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
(for example, 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
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3924 9th Avenue West
Bradenton, Florida 34205
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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5090 N 40th St # 250
Phoenix, Arizona 85018
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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3603 Paesanos Parkway
San Antonio, Texas 78231
210-614-4884
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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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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Atlanta, Georgia 30327
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3945 Soler
Buenos Aires, 1425
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Charlotte, North Carolina
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Cordova, Tennessee 38018
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Denver, Colorado 80210
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Fairfield, Connecticut 06824
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Fort Collins, Colorado 80528
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Fort Wayne, Indiana 46805
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Freehold, New Jersey 07728
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Golden Valley, Minnesota 55422
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Greenville, South Carolina 29615
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Hollywood, Florida 33021
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Indianapolis, Indiana 46256
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Knoxville, Tennessee 37934
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Latham, New York 12110
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Lexington, Kentucky 40513
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Louisville, Kentucky 40207
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Lubbock, Texas 79410
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Maitland, Florida 32751
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1095 Northwest 14th Terrace
Miami, Florida 33136
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Nashville, Tennessee 37205
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Newark, New Jersey 07103
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Orlando, Florida 32806
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Palo Alto, California 94304
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Patchogue, New York 11772
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Phoenix, Arizona 85050
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Plainview, New York 11803
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10 East Cambridge Circle Drive
Prairie Village, Kansas 66206
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Raleigh, North Carolina 27607
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San Antonio, Texas 78258
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505 Parnassus Avenue
San Francisco, California 94143
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Sarasota, Florida 34233
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Seattle, Washington 98122
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Stony Brook, New York 11794
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Sun City, Arizona 85351
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Teaneck, New Jersey 07666
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718 Teaneck Road
Teaneck, New Jersey 07666
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Toms River, New Jersey 08755
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Torrance, California 90502
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110 Cedar Street
Wellesley, Massachusetts 02481
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Westerville, Ohio 43081
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Willow Grove, Pennsylvania 19090
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