Higher Dose Ocrelizumab in Human Relapsing Multiple Sclerosis
In a Phase IIIb study involving 864 participants with relapsing multiple sclerosis, a higher dose of Ocrelizumab (1200 mg or 1800 mg) was compared to the standard 600 mg dose. Analysis for the primary endpoint of disability progression was conducted but findings did not generate usable median and confidence interval estimates due to a lack of events, following the exclusion of 4 participants due to major violations.
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Why it matters
Understanding different dosages of Ocrelizumab is crucial for optimizing treatment in relapsing multiple sclerosis. This study aims to explore the relationship between higher dosing and disability progression, which could inform future therapeutic approaches.
What this does not prove
The study results are not peer-reviewed, and the insufficient number of events prevented estimation of median and confidence interval, limiting the conclusions that can be drawn about the drug's efficacy at higher doses.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 864 · basis not reported
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- RRMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (15)
study phaseA Phase IIIb Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis
study designThis is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab
subjects"preAssignmentDetails": "Participants received double-blinded treatment (DBT) with either ocrelizumab higher dose (1200 milligrams \\[mg\\] or 1800 mg) based on the participant's body weight (BW) or ocrelizumab 600 mg for a minimum of up to 120 weeks.
sample sizeA total of 864 participants with relapsing multiple sclerosis (RMS) took part in the study at 122 investigative sites across 21 countries.
randomized"briefSummary": "This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.",
controlled"briefSummary": "This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.",
peer reviewedSponsor-submitted results are available; this does not establish peer review.
regulatory approval detailsisFdaRegulatedDrug
relevant ms types"recruitmentDetails": "A total of 864 participants with relapsing multiple sclerosis (RMS) took part in the study at 122 investigative sites across 21 countries.
intervention"description": "Participants will be randomized to receive a minimum of 5 higher treatment doses based on their body weight at baseline: 1200 mg (participant's body weight \\<75 kilograms \\[kg\\]) or 1800 mg (participant's body weight ≥ 75 kg) of ocrelizumab administered by IV infusion Q24W in the DBT phase.
comparator"description": "Participants received ocrelizumab, 600 mg, as an intravenous (IV) infusion, every 24 weeks (Q24W)."
primary endpoint"description": "Time to onset of 12-week cCDP=first occurrence of a 12-week cCDP according to at least 1 of 3 criteria: 1) CDP=12-week CI from baseline in EDSS score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 12-week CI≥0.5 point in participants with baseline EDSS score of \\>5.5 OR 2) 12-week CI of ≥20% FB in T25FWT score OR 3) 12-week CI of ≥ 20% FB in 9-HPT score.
follow upParticipants will be treated for a minimum of 120 weeks in the double-blind treatment (DBT) phase.
findings4 participants had a major good clinical practice (GCP) violation and were hence excluded from all analysis sets used in this study.
limitationsThe median and 95% confidence interval were not estimable due to an insufficient number of participants with events.
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