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Research summary · AI summary · not yet reviewedHuman studyInterventionalTrial registry record – peer review not applicable
Evaluating Ocrelizumab Pharmacokinetics in Children with RRMS
This interventional study is focused on assessing the pharmacokinetics of ocrelizumab, formulated with rHuPH20, in children and adolescents aged 10 to under 18 with relapsing-remitting multiple sclerosis (RRMS). The study spans 48 weeks, followed by an optional extension and extended safety follow-up.
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This plain-English summary was written by AI from a trial registry record and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
- Human efficacy
- Not yet assessed
- Mechanism
- Not yet assessed
- Evidence strength
- Not yet assessed
- Outcome
- Not yet assessed
Why it matters
Understanding the pharmacokinetics of ocrelizumab in this age group is crucial for ensuring its safe and effective use in young patients with RRMS.
What this does not prove
No results have been posted, and the details on planned enrollment and endpoints do not convey actual findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 25 · Estimated
- Randomised
- No
- Controlled
- Not applicable
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Yes
- Research areas
- Not classified
Original sources
Supporting passages (11)
study design"studyType": "INTERVENTIONAL"
subjects"Relapsing-remitting Multiple Sclerosis"
sample size"count": 25
sample size basis"type": "ESTIMATED"
randomized"allocation": "NA"
controlled"allocation": "NA"
regulatory approval"isFdaRegulatedDrug": true
intervention"name": "Ocrelizumab co-formulated with rHuPH20"
primary endpoint"primaryOutcomes": [ { "measure": "Peak Concentration (Cmax) of Ocrelizumab After the First SC Injection", "timeFrame": "Up to 24 weeks" }, { "measure": "Area Under the Concentration-time Curve Over a Dosing Interval (AUCtau) After the First SC Injection of Ocrelizumab", "timeFrame": "Up to 24 weeks" } ]
findings"briefSummary": "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.
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
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