A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis
The MS Center at EvergreenHealth is conducting a Phase IIIb, randomized, double-blind study to evaluate the efficacy and safety of higher dose ocrelizumab compared with the approved dose of ocrelizumab in patients with Relapsing Multiple Sclerosis (RMS).
Who may be eligible to participate?
Patients 18 to 55 years of age with RMS may be eligible to participate. Other inclusion and exclusion criteria apply.
What does participation involve?
Eligible patients will be randomized to receive either the higher dose or the approved dose of ocrelizumab by IV infusion every 24 weeks. This study will consist of the following phases:
- screening, double blind treatment (DBT) phase
- open-label extension (OLE) phase
- safety follow-up (SFU)
- B cell monitoring (BCM)
Enrolled patients will receive a minimum of five doses of either the higher dose or the approved dose of ocrelizumab.
Investigator
Theodore Brown, MD, MPH, EvergreenHealth MS Center
