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Switch to Ofatumumab and Level of Immunoglobulins

Not Yet RecruitingN/A

Sponsor: University Hospital, Lille

Conditions: Multiple Sclerosis

Interventions: ofatumumab

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Lille, France