©2022 Stanford Medicine
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Not Recruiting
Trial ID: NCT01412333
Purpose
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).
Official Title
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
Eligibility
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
Intervention(s):
drug: ocrelizumab
drug: Interferon beta-1a
drug: Ocrelizumab-matching placebo
drug: Interferon beta-1a-matching placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Clinical Trials Office
(650) 498-7061