Switch to Ofatumumab and Level of Immunoglobulins
Starting soon
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT07625800
- Run by
- University Hospital, Lille
- People needed
- 115
- Starts
- 2026-06-01
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CHU de Lille — Lille, France
Full record on ClinicalTrials.gov
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