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

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 milligrams (mg) intravenously (iv) every 24 weeks plus Rebif placebo subcutaneously (sc) three times weekly, or, in Group B, Rebif 8.8 micrograms (mcg) (Weeks 1 and 2), 22 mcg (Weeks 3 and 4), and 44 mcg (Week 5 and thereafter) sc three 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 Interferon beta-1a

Eligibility

You can join if…

Open to people ages 18–55

  • 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 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

Locations

  • San Francisco, California, 94115, United States
  • Sacramento, California, 95817, United States
  • Sacramento, California, 95816, United States
  • Pasadena, California, 91105, United States
  • RIverside, California, 92505, United States
  • Newport Beach, California, 92663, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT01247324
Phase
Phase 3
Lead Scientist
Bruce Cree
Study Type
Interventional
Last Updated
October 1, 2016