Status:
COMPLETED
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
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 mult...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
821 Patients enrolled
Trial Details
Trial ID
NCT01247324
Start Date
August 31 2011
End Date
December 31 2022
Last Update
March 4 2024
Active Locations (142)
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1
21st Century Neurology
Phoenix, Arizona, United States, 85004
2
Mercy Medical Group
Carmichael, California, United States, 95608
3
Scripps Clinic
La Jolla, California, United States, 92037
4
MS Center of California
Laguna Hills, California, United States, 92653