A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
Phase 2
182
about 5 years
18–65
9 sites in CA, CO, FL +5
What this study is about
Researchers are testing whether a new ocrelizumab formulation is the same as the existing one when given under the skin. The trial will involve two phases: a controlled phase where participants receive either the new or existing formulation, and a continuation phase where all participants receive the new formulation.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Ocrelizumab Reference Formulation
- 2.Take Ocrelizumab Test Formulation
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
injection (Injection)
Primary: Maximum Serum Concentration (Cmax) of Ocrelizumab
Secondary: Number of Participants With Adverse Events (AEs)
Neurology