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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01412333
First received: August 8, 2011
Last updated: October 20, 2014
Last verified: October 2014

August 8, 2011
October 20, 2014
September 2011
January 2020   (final data collection date for primary outcome measure)
Annualized protocol-defined relapse rate by 2 years in patients with relapsing MS [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Relapse rate: Occurrence of new or worsening neurological symptoms, as defined by protocol [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01412333 on ClinicalTrials.gov Archive Site
  • Time to onset of sustained disability progression for at least 12 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Time to onset of sustained disability progression for at least 24 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Proportion of relapse-free patients [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Change in total T2 lesion volume as detected by brain MRI [ Time Frame: from baseline to Week 96 ] [ Designated as safety issue: No ]
  • Total number of new, and/or enlarging T2 hyperintense lesions as detected 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 ]
  • Change in brain volume as detected by brain MRI [ Time Frame: from Week 24 to Week 96 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • Time to onset of sustained disability progression for at least 12 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Time to onset of sustained disability progression for at least 24 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Proportion of relapse-free patients [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Change in total T2 lesion volume as detected by brain MRI [ Time Frame: from baseline to Week 96 ] [ Designated as safety issue: No ]
  • Total number of new, and/or enlarging T2 hyperintense lesions as detected 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 ]
  • Change in brain volume as detected by brain MRI [ Time Frame: from Week 24 to Week 96 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
  • 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: 120 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis
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

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 wee ks plus Rebif placebo subcutaneously (sc) three times weekly, or, in group B, R ebif 8.8 mcg (Weeks 1+2)/22 mcg (Weeks 3+4)/44 mcg (Week 5 and following) sc thr ee times weekly plus ocrelizumab placebo iv every 24 weeks. Anticipated time on study treatment is 96 weeks.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
  • Drug: Rebif
    8.8 mcg (Weeks 1+2) / 22 mcg (Weeks 3+4) / 44mcg (Week 5 and following) subcutaneously 3 times weekly, 96 weeks
    Other Name: Rebif
  • Drug: Rebif placebo
    Rebif dummy placebo sc according to schedule in Rebif active group B
  • 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), 96 weeks
  • Drug: ocrelizumab placebo
    Ocrelizumab dummy placebo iv according to schedule in ocrelizumab active group A
  • Experimental: A
    Interventions:
    • Drug: Rebif placebo
    • Drug: ocrelizumab
  • Active Comparator: B
    Interventions:
    • Drug: Rebif
    • Drug: ocrelizumab placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
835
January 2020
January 2020   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States,   Argentina,   Belarus,   Belgium,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   United Kingdom,   Colombia,   Croatia,   Czech Republic,   France,   Germany,   Ireland,   Italy,   Mexico,   Norway,   Poland,   Russian Federation,   Slovakia,   Spain,   Sweden,   Turkey,   Ukraine
 
NCT01412333
WA21093
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP