This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.
Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.
Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain
Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.
Time frame: Week 12 to Week 24
Annualized Protocol Defined Relapse Rate at Week 24
Adjusted annualized relapse rate for geographical region is reported here. The relapse rate was calculated as the total number of relapses for each participant divided by the total number of patient-years.
Time frame: Week 24
Percentage of Participants Who Remained Relapse Free at Week 24
Percentage of participants who remained relapse free at week 24 were reported. Percentages have been rounded off to the first decimal.
Time frame: Week 24
Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24
Change from baseline in total volume of T2 lesions on MRI scans of the brain at Week 24 was reported.
Time frame: Baseline, Week 24
Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain
Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.
Time frame: Weeks 4 to Week 24
Total Number of Gadolinium-Enhancing T1 Lesions
Total number of gadolinium-enhancing T1 lesions from Week 4 to Week 24 were reported.
Time frame: Weeks 4 to Week 24
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Phoenix Neurological Associates Ltd
Phoenix, Arizona, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
East Bay Physicians Med Group;Sutter East Bay Med Foundation
Berkeley, California, United States
University of California San Francisco
San Francisco, California, United States
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States
Bradenton Research Center
Bradenton, Florida, United States
MS Center of Vero Beach
Vero Beach, Florida, United States
Shepherd Center; Multiple Sclerosis Center
Atlanta, Georgia, United States
University of Chicago; Neurology
Chicago, Illinois, United States
Kansas University Medical Center
Kansas City, Kansas, United States
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