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Research summary · AI summary · not yet reviewedHuman studyPhase 3Trial registry record – peer review not applicable
Phase 3 Study of Ocrelizumab in Human Subjects
A Phase 3 interventional study planned to enroll 1300 participants to evaluate the incidence and severity of adverse events associated with Ocrelizumab over a follow-up period of up to 44 months. However, no results or data have been reported yet.
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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 established from this source
- Mechanism
- Not reported
- Evidence strength
- No results yet
- Outcome
- Not reported
Why it matters
This study is significant as it aims to assess the safety profile of Ocrelizumab, but without published findings, its impact remains undetermined.
What this does not prove
The study has no posted results; planned enrollment and endpoints do not constitute findings, limiting conclusions.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 1300 · planned enrolment
- Randomised
- Not applicable
- Controlled
- No
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- people; ages from 18 Years; sex All
- Size of effect
- Not reported
- Secondary endpoints
- Change in Expanded Disability Status Scale (EDSS) score over time; Change in 9-Hole Peg Test (9HPT) over time; Change in Timed 25-Foot Walk Test (T25FWT) over time; The number of T1 lesions and number of new or enlarging T2 lesions; The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
Supporting passages (15)
study phasePhase: Phase 3
study designStudy type: Interventional
subjectsParticipants: people; ages from 18 Years; sex All
sample sizeEnrollment: 1300 participants (estimated)
interventionInterventions: Ocrelizumab
primary endpointPrimary endpoints: Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0
follow upFollow-up: Up to 44 months; Week 0, 24, 48, 72, 96, 120, 168
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
populationpeople; ages from 18 Years; sex All
secondary endpointsChange in Expanded Disability Status Scale (EDSS) score over time
findingsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
peer reviewedTrial registry record.
randomizedAllocation: Not applicable
controlledIntervention model: Single group
sample size basisEnrollment: 1300 participants (estimated)
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