Switch to Ofatumumab and Level of Immunoglobulins

Обзор

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.

Подробное описание

time perspective: retrospective and prospective

Вмешательства

• Препарат ofatumumab
  There is no treatment allocation. Participants with MS that initiated treatment with ofatumumab (Kesimpta ®) as per neurologist practice and regardless of the study protocol.

Первичные конечные точки

• Slope of serum immunoglobulin G (IgG) levels during ocrelizumab treatment period (minimum 18 months) [Срок оценки: 42 months]
• Slope of serum immunoglobulin G (IgG) levels during ofatumumab treatment period (24 months) [Срок оценки: 42 months]

Вторичные конечные точки (12)

• Age at baseline (years) [Срок оценки: Baseline]
• Number and percentage of patients with stable serum IgG levels [Срок оценки: 24 months]
• Number of severe infections occurring during ocrelizumab treatment period prior to switch to ofatumumab [Срок оценки: 18 months]
• Slope of serum immunoglobulin M (IgM) levels during ocrelizumab treatment period (minimum 18 months) [Срок оценки: 24 months]
• Distribution of Expanded Disability Status Scale (EDSS) scores after switch to ofatumumab [Срок оценки: 24 months]
• Number of patients who discontinued ofatumumab before the end of follow-up [Срок оценки: 24 months]
• Number and type of adverse events (AEs) during ofatumumab follow-up period [Срок оценки: 24 months]
• Disease duration (years since diagnosis) [Срок оценки: Baseline]
• Sex distribution (male/female, percentage of patients) [Срок оценки: Baseline]
• Number and percentage of patients with increased serum IgG levels [Срок оценки: 24 months]
• Slope of serum immunoglobulin M (IgM) levels during ofatumumab treatment period (24 months) [Срок оценки: 24 months]
• Distribution of Fatigue Severity Scale (FSS) scores after switch to ofatumumab [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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

• At the discretion of the investigator, if a benefit for patients is expected based on their experience and depending on patient's characteristics

Критерии исключения

• Patients with ocrelizumab dose spacing > 8 months in the last 18 months before switch
• Patient who underwent an immunoglobulin supplementation therapy within 18 months before the switch
• Ongoing or planned pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 1 центр

• CHU de Lille — Lille

Идентификаторы

NCT: NCT07625800 · 2024_0720 · 2025-A02557-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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