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Not yet recruiting NCT07625800

Switch to Ofatumumab and Level of Immunoglobulins

— Observational Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ofatumumab.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Drug 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.

Primary outcome measures

  • Slope of serum immunoglobulin G (IgG) levels during ocrelizumab treatment period (minimum 18 months) [Time frame: 42 months]
  • Slope of serum immunoglobulin G (IgG) levels during ofatumumab treatment period (24 months) [Time frame: 42 months]
Secondary outcome measures (12)
  • Age at baseline (years) [Time frame: Baseline]
  • Number and percentage of patients with stable serum IgG levels [Time frame: 24 months]
  • Number of severe infections occurring during ocrelizumab treatment period prior to switch to ofatumumab [Time frame: 18 months]
  • Slope of serum immunoglobulin M (IgM) levels during ocrelizumab treatment period (minimum 18 months) [Time frame: 24 months]
  • Distribution of Expanded Disability Status Scale (EDSS) scores after switch to ofatumumab [Time frame: 24 months]
  • Number of patients who discontinued ofatumumab before the end of follow-up [Time frame: 24 months]
  • Number and type of adverse events (AEs) during ofatumumab follow-up period [Time frame: 24 months]
  • Disease duration (years since diagnosis) [Time frame: Baseline]
  • Sex distribution (male/female, percentage of patients) [Time frame: Baseline]
  • Number and percentage of patients with increased serum IgG levels [Time frame: 24 months]
  • Slope of serum immunoglobulin M (IgM) levels during ofatumumab treatment period (24 months) [Time frame: 24 months]
  • Distribution of Fatigue Severity Scale (FSS) scores after switch to ofatumumab [Time frame: 24 months]

Eligibility criteria

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
  • 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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

France · 1 center
  • CHU de Lille — Lille

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗