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 |
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.
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
University of South Florida The University of South Florida is a high-impact, global research university...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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1010 Edgehill Road North
Charlotte, North Carolina 28207
Charlotte, North Carolina 28207
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The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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5501 Old York Road
Philadelphia, Pennsylvania 19141
Philadelphia, Pennsylvania 19141
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915 6th Avenue
Tacoma, Washington 98405
Tacoma, Washington 98405
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