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Eligibility
for people ages 18 years to 55 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

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 participants with relapsing multiple sclerosis. Participants will be randomized to receive either in Group A, ocrelizumab 600 milligram (mg) intravenously (IV) every 24 weeks plus Rabif placebo subcutaneously (SC) 3 times weekly, or, in Group B, Rebif 8.8 microgram (mcg) (Weeks 1 and 2), 22 mcg (Weeks 3 and 4), and 44 mcg (Week 5 and thereafter) SC 3 times weekly plus ocrelizumab placebo IV 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, providing they fulfill the eligibility criteria.

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

Keywords

Relapsing Multiple Sclerosis Interferons Interferon beta-1a Interferon-beta

Eligibility

You can join if…

Open to people ages 18 years to 55 years

  • 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

You CAN'T join if...

  • Primary progressive multiple sclerosis
  • Disease duration of more than 10 years in patients with EDSS score less than or equal to (

  • 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

Locations

  • Stanford, California, 94305, USA
  • Torrance, California, 90502, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT01412333
Phase
Phase 3
Study Type
Interventional
Last Updated
October 2016