Switching to Ofatumumab: IgG Levels in People with MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adult people with relapsing multiple sclerosis who switch from ocrelizumab to ofatumumab. It uses retrospective and prospective data over 24 months to see if the drop in IgG seen with ocrelizumab slows or stops after the switch. The analysis focuses on IgG trajectories following transition and is conducted in routine clinical practice at CHU de Lille in France. Eligible participants must have had at least 18 months of ocrelizumab and a documented IgG decline prior to switching. The study design is non-randomized and aims to describe real-world outcomes without a predefined comparison group.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Lille
  Lille, France Recruiting

Study contacts

• Study coordinator: PATRICK VERMERSCH, Pr
• Email: patrick.vermersch@chu-lille.fr
• Phone: 06.33.38.32.60

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.