A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety
A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUTANEOUS OCRELIZUMAB VERSUS INTRAVENOUS OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
Compared with
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
1. Serum ocrelizumab area under the concentration-time curve (AUC[w1-12]) after SC administration compared to IV infusion from Day 1 to Week 12
How the body handles the medicine
Other measures (1)
1. Maximum serum concentration (Cmax) of ocrelizumab SC in patients with MS
How the body handles the medicine
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History
- In scope changed from true to false
Started
May 2021