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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02557-42 | Other Identifier | [ID-RCB number, ANSM] |
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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.
time perspective: retrospective and prospective
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab | Adult patients (≥18 years) with relapsing multiple sclerosis treated with ocrelizumab for at least 18 months and already switched or switching from ocrelizumab to ofatumumab treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ofatumumab | Drug | There is no treatment allocation. Participants with MS that initiated treatment with ofatumumab (Kesimpta ®) as per neurologist practice and regardless of the study protocol. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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.
Patients with a decrease of IgG at a minimum of two consecutive dosages (around six months apart) during ocrelizumab treatment*.
Patients already switched or switching from ocrelizumab to ofatumumab treatment (decision independent from the study*).
Patients agreeing to participate to the study.
Able to provide their non-opposition
Exclusion Criteria:
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The study population will be adult patients with MS (women and men) who initiate treatment with ofatumumab after a treatment with ocrelizumab
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PATRICK VERMERSCH, Pr | Contact | 06.33.38.32.60 | patrick.vermersch@chu-lille.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lille | Lille | 59000 | France |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C527517 | ofatumumab |
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| 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 | Expanded Disability Status Scale (EDSS): score range 0-10, where higher scores indicate greater neurological disability (worse outcome). | 24 months |
| 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 | Fatigue Severity Scale (FSS): score range 9-63, where higher scores indicate greater fatigue severity (worse outcome). | 24 months |
| Distribution of Multiple Sclerosis Functional Composite (MSFC) scores after switch to ofatumumab | Multiple Sclerosis Functional Composite (MSFC): standardized composite score (z-score), with higher scores indicating better neurological function (better outcome). | 24 months |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |