The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
193
Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm.
Profound Research, LLC
Carlsbad, California, United States
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States
Neurology Associates PA
Maitland, Florida, United States
University of South Florida
Tampa, Florida, United States
Johns Hopkins University School Of Medicine
Baltimore, Maryland, United States
Area Under the Serum Concentration-time Curve Over the First 12 Weeks Post-dose (AUC0-12W) of Ocrelizumab
Time frame: Up to 12 weeks
Maximum Serum Concentration (Cmax) of Ocrelizumab
Time frame: Up to 12 weeks
Number of Participants With Adverse Events (AEs)
Time frame: Up to 168 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Massachusetts Medical School
Worcester, Massachusetts, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Hope Neurology
Knoxville, Tennessee, United States
Swedish Medical Center
Seattle, Washington, United States
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
CABA, Buenos Aires, Argentina
...and 40 more locations