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

  • Neurodegenerative Disorder
  • Relapsing Multiple Sclerosis (RMS)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Countries
  • Argentina
  • Belarus
  • Belgium
  • Bosnia and Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • France
  • Germany
  • Ireland
  • Italy
  • Mexico
  • Norway
  • Poland
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • Türkiye
  • Ukraine
  • United Kingdom
  • United States
Study Identifier:

NCT01412333 2010-020315-36 WA21093

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study 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 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).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT01412333, WA21093, 2010-020315-36 Study Identifier
      Interferon beta-1a, Ocrelizumab-matching placebo, Ocrelizumab, Interferon beta-1a-matching placebo Treatments
      Relapsing Multiple Sclerosis Condition
      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 Criteria

      All Gender
      ≥18 Years & ≤ 55 Years Age
      No Healthy Volunteers
      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 (</=) 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 (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

      For the latest version of this information please go to www.forpatients.roche.com

       

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