RecruitingRelapsing MSNCT07625800

What it found

Still running

No result yet.

What was tested

Treatment tested

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 progression
  • 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

    Safety
  • 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

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 registry

About 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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Related trials

History

  1. Status changed from Not yet recruiting to Recruiting
  1. Started

    Oct 2026

  2. Main results due

    Jun 2029

  3. Finished

    Jun 2029

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