For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
  2. 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)
  3. Neurologic stability for greater than or equal to (>/=) 30 days prior to both screening and baseline
  4. Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

EXCLUSION CRITERIA

  1. Primary progressive multiple sclerosis
  2. Disease duration of more than 10 years in patients with EDSS score less than or equal to (
  3. Contraindications for MRI
  4. Known presence of other neurological disorders which may mimic multiple sclerosis
  5. Pregnancy or lactation
  6. Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  7. History of or currently active primary or secondary immunodeficiency
  8. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  9. 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)
  10. History of progressive multifocal leukoencephalopathy
  11. Contraindications to or intolerance of oral or IV corticosteroids
  12. Contraindications to Rebif or incompatibility with Rebif use
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Multiple Sclerosis, Relapsing-Remitting,Relapsing Multiple Sclerosis

Age (in years)

18 - 55

Phase

Phase 3

Participants needed

835

Est. Completion Date

Dec 2023

Treatment type

Interventional


Sponsor

Hoffmann-La Roche

ClinicalTrials.gov identifier

NCT01412333

Study number

WA21093

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