A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Interferon beta-1a; Ocrelizumab-matching placebo; Ocrelizumab; Interferon beta-1a-matching placebo
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 821.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

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). 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.
    

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