This study is in progress, not accepting new patients

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

a study on Multiple Sclerosis

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

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
August 30, 2018