Summary

for people ages 18-55 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Bruce Cree

Description

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.

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 Sclerosis Multiple Sclerosis Interferons Interferon-beta Interferon beta-1a Ocrelizumab Interferon beta-1a 44 mcg SC

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

  • University of California at San Francisco
    San Francisco California 94115 United States
  • University of California Davis Medical System
    Sacramento California 95817 United States
  • Mercy Medical Group
    Sacramento California 95816 United States

Lead Scientist

  • Bruce Cree
    Bruce Cree, MD, PhD, MAS is a Professor of Clinical Neurology and is the George A. Zimmermann Endowed Professor in Multiple Sclerosis in the Department of Neurology at the University of California San Francisco. Dr. Cree completed his MD and PhD in Biochemistry at UCSF. His neurology residency training was at Columbia University.

Details

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