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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: November 23, 2010
Last updated: May 4, 2016
Last verified: May 2016
This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with Rebif (interferon beta-1a) in patients with relapsing multiple sclerosis. Patients will be randomized to receive either in group A, ocrelizumab 600 mg intravenously (iv) every 24 weeks plus Rebif placebo subcutaneously (sc) three times weekly, or, in group B, Rebif 8.8 mcg (Weeks 1+2)/22 mcg (Weeks 3+4)/44 mcg (Week 5 and following) sc three times weekly plus ocrelizumab placebo iv every 24 weeks. Anticipated time on study treatment is 96 weeks.

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Ocrelizumab
Drug: Ocrelizumab placebo
Drug: Rebif
Drug: Rebif placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Annualized Protocol-defined Relapse Rate by 2 Years in Participants Wth Relapsing MS [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Onset of Confirmed Disability Progression for at least 12 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Time to Onset of Confirmed Disability Progression for at least 24 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Total Number of new, and/or Enlarging T2 Hyperintense Lesions as Dtected by Brain MRI [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change in Multiple Sclerosis Functional Composite Scale (MSFCS) score [ Time Frame: from Baseline to Week 96 ] [ Designated as safety issue: No ]
  • Percent Change in Brain Volume as Detected by MRI [ Time Frame: from Week 24 to Week 96 ] [ Designated as safety issue: No ]
  • Total Number of T1 Gadolinium-enhancing (Gd-enhancing) Lesions as Detected by Brain MRI at Weeks 24, 48, and 96 [ Time Frame: Week 24, 48, 96 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Confirmed Disability Improvement for at least 12 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Total Number of T1-hypointense Lesions at 24, 48, and 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change in Short Form-36 Physical Component Summary (SF-36 PCS) Score [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
  • Percentage of Participants who Have No Evidence of Disease Activity (NEDA) by Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Exposure to ocrelizumab (area under the concentration - time curve) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity: Human anti-human antibodies (HAHA) levels [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Enrollment: 817
Study Start Date: August 2011
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ocrelizumab
600 mg iv every 24 weeks (dual infusions of 300 mg on Day 1 and 15 of Cycle 1, single infusion of 600 mg on Day 1 of each following cycle.
Drug: Ocrelizumab
600 mg iv every 24 weeks (dual infusions of 300 mg on Day 1 and 15 of Cycle 1, single infusion of 600 mg on Day 1 of each following cycle
Drug: Rebif placebo
Rebif dummy placebo SC according to schedule in Rebif active group.
Active Comparator: Rebif
8.8 mcg (Weeks 1+2) / 22 mcg (Weeks 3+4) / 44 mcg (Week 5 and following) subcutaneously 3 times weekly.
Drug: Ocrelizumab placebo
Ocrelizumab dummy placebo iv according to schedule in ocrelizumab active group.
Drug: Rebif
8.8 mcg (Weeks 1+2) / 22 mcg (Weeks 3+4) / 44 mcg (Week 5 and following) subcutaneously 3 times weekly


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, 18-55 years of age inclusive
  • 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 >/= 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 </= 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, 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01247324

  Show 192 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01247324     History of Changes
Other Study ID Numbers: WA21092  2010-020337-99 
Study First Received: November 23, 2010
Last Updated: May 4, 2016
Health Authority: Slovakia: Ministry of Health

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon beta-1a
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 30, 2016