The main purpose of this study is to evaluate the pharmacokinetics (PK) of ocrelizumab administered subcutaneously (SC) in children and adolescents aged 10 to \<18 years with RRMS. The study consists of a 48-week treatment period, an Optional Ocrelizumab Extension (OOE) period of at least 48 weeks, and Safety Follow-up (SFU) for 104 weeks.
For participants who are under 18 years old at the end of the OOE period, it may be extended until the participant turns 18 years old (or as required per local regulation) or until commercial ocrelizumab intravenous (IV) is approved for children and adolescents and available in the country for these participants, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Ocrelizumab co-formulated with rHuPH20 will be administered as per the schedule specified in the arm.
Peak Concentration (Cmax) of Ocrelizumab After the First SC Injection
Time frame: Up to 24 weeks
Area Under the Concentration-time Curve Over a Dosing Interval (AUCtau) After the First SC Injection of Ocrelizumab
Time frame: Up to 24 weeks
Incidence and Nature of Adverse Events (AEs)
Time frame: Up to 260 weeks
Percentage of Participants Who Discontinued Study Treatment due to AEs
Time frame: Up to 96 weeks
Levels of Cluster of Differentiation 19+ (CD19+) B-cell Count in Blood
Time frame: Up to 260 weeks
Number of Participants With Anti-drug Antibodies (ADAs) to Ocrelizumab
Time frame: Up to 260 weeks
Number of Participants With ADAs to rHuPH20
Time frame: Up to 260 weeks
Reference Study ID Number: BA45841 https://forpatients.roche.com/
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