Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, NIS, Ofatumumab, Kesimpta, Ocrelizumab, IgG, IgM
Brief summary
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.
Detailed description
time perspective: retrospective and prospective
Interventions
DRUGofatumumab
There is no treatment allocation. Participants with MS that initiated treatment with ofatumumab (Kesimpta ®) as per neurologist practice and regardless of the study protocol.
Sponsors
University Hospital, Lille
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Expanded Disability Status Scale (EDSS): score range 0-10, where higher scores indicate greater neurological disability (worse outcome). |
| Number 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 | — |
| Disease 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 | — |
| Slope of serum immunoglobulin M (IgM) levels during ofatumumab treatment period (24 months) | 24 months | — |
| Distribution of Fatigue Severity Scale (FSS) scores after switch to ofatumumab | 24 months | Fatigue Severity Scale (FSS): score range 9-63, where higher scores indicate greater fatigue severity (worse outcome). |
| Distribution of Multiple Sclerosis Functional Composite (MSFC) scores after switch to ofatumumab | 24 months | Multiple Sclerosis Functional Composite (MSFC): standardized composite score (z-score), with higher scores indicating better neurological function (better outcome). |
| Number of relapses per patient after switch to ofatumumab | 24 months | — |
| Reasons for discontinuation of ofatumumab before the end of follow-up | 24 months | — |
| Number and type of serious adverse events (SAEs) during ofatumumab follow-up period | 24 months | — |
Countries
France
Contacts
CONTACTPATRICK VERMERSCH, Pr
Outcome results
None listed