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Research summary · AI summary · not yet reviewedHuman studyObservationalTrial registry record – peer review not applicable
Study on Ofatumumab in Relapsing Multiple Sclerosis Patients
An observational study with 106 participants was planned to evaluate the proportion of patients with relapsing multiple sclerosis (RMS) demonstrating NEDA-3 (No Evidence of Disease Activity). Follow-ups were scheduled from baseline through 24 months, but no results have been posted.
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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
Understanding the effectiveness of treatments like Ofatumumab in preventing disease activity could have implications for managing RMS, but the absence of results limits our understanding.
What this does not prove
Results and findings are not available, preventing any concrete conclusions about the study's outcomes.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Observational
- Participants / samples
- 106 · actual
- 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
- Not reported
- Research areas
- Not classified
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- Patients with relapsing multiple sclerosis (RMS) with disease activity defined by clinical assessment or MRI analysis
- Size of effect
- Not reported
- Secondary endpoints
- Proportion of patients displaying NEDA-3, as well as individual NEDA components; Proportion of patients permanently discontinuing Ofatumumab during the study
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
Supporting passages (16)
study designStudy type: Observational
study phaseStudy type: Observational
subjectsParticipants: people; ages from 18 Years to 99 Years; sex All
speciesParticipants: people; ages from 18 Years to 99 Years; sex All
sample sizeEnrollment: 106 participants (actual)
sample size basisEnrollment: 106 participants (actual)
randomizedNo results are posted. Planned enrolment and endpoints are not findings.
controlledNo results are posted. Planned enrolment and endpoints are not findings.
peer reviewedTrial registry record.
interventionInterventions: Ofatumumab
primary endpointPrimary endpoints: Proportion of patients demonstrating NEDA-3
population1. Patients with relapsing multiple sclerosis (RMS) with disease activity defined by clinical assessment or MRI analysis.
secondary endpoints"description": "Proportion of patients displaying NEDA-3, as well as individual NEDA components (i) experiencing no confirmed clinical relapses, (ii) lack of diseases progression measured by expanded disability status scale (EDSS) and (iii) absence of new disease activity (new or enhancing T2 or Gadolinium-positive T1 lesions (in case Gadolinium was utilized)), respectively, in the first treatment year (Baseline to month 12), the second treatment year (month 12 to month 24) as well as over the whole study period (Baseline to month 24).",
findingsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
follow upFollow-up: from month 12 up to month 24; Baseline, month 12, month 24; Up to 24 months
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