SOLI
What it found
No result yet.
What was tested
Treatment tested
- Ofatumumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Slope of serum immunoglobulin G (IgG) levels during ocrelizumab treatment period (minimum 18 months)
42 months
Slope of serum immunoglobulin G (IgG) levels during ofatumumab treatment period (24 months)
42 months
Other measures (16)
Age at baseline (years)
Baseline
Number and percentage of patients with stable serum IgG levels
24 months
Number of severe infections occurring during ocrelizumab treatment period prior to switch to ofatumumab
18 months
Slope of serum immunoglobulin M (IgM) levels during ocrelizumab treatment period (minimum 18 months)
24 months
Distribution of Expanded Disability Status Scale (EDSS) scores after switch to ofatumumab
24 months
Disability progressionNumber of patients who discontinued ofatumumab before the end of follow-up
24 months
Number and type of adverse events (AEs) during ofatumumab follow-up period
24 months
SafetyDisease duration (years since diagnosis)
Baseline
Sex distribution (male/female, percentage of patients)
Baseline
Number and percentage of patients with increased serum IgG levels
24 months
Who could take part
Relapsing MS · 18 to 65
Inclusion Criteria: 1. Adult patients (≥ 18 years old) who had been treated with ocrelizumab for a relapsing form of Multiple Sclerosis according to the ocrelizumab marketing authorization (MA) treatment regimen for at least 18 months. 2. Patients with a decrease of IgG at a minimum of two consecutive dosages (around six months apart) during ocrelizumab treatment*. 3. Patients already switched or switching from ocrelizumab to ofatumumab treatment (decision independent from the study*). 4. Patients agreeing to participate to the study. 5. Able to provide their non-opposition * At the discretion of the investigator, if a benefit for patients is expected based on their experience and depending on patient's characteristics Exclusion Criteria: 1. Patients with ocrelizumab dose spacing > 8 months in the last 18 months before switch 2. Patient who underwent an immunoglobulin supplementation therapy within 18 months before the switch 3. Ongoing or planned pregnancy
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
This real-life study aims to describe IgG levels after switching from ocrelizumab 600 mg IV every 6 to 8 months in Patients with Multiple Sclerosis (PwMS) to ofatumumab 20 mg SC every month and showing a decreasing level of IgG during treatment by ocrelizumab in real life practice in France over 24 months of follow-up. The primary objective is therefore to determine if the downward trend of IgG observed during ocrelizumab treatment is modified after a switch to ofatumumab, in PwMS treated during at least 18 months of ocrelizumab in real life practice, over 24 months of follow-up.
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History
- Status changed from Not yet recruiting to Recruiting
Started
Oct 2026
Main results due
Jun 2029
Finished
Jun 2029
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