← Back to all trials
Not Yet Recruiting
NCT07625800
Switch to Ofatumumab and Level of Immunoglobulins
Conditions: Multiple Sclerosis
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Enrollment: 115
Sponsor: University Hospital, Lille
Location: CHU de Lille Lille
Summary
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 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
Source: ClinicalTrials.gov (NCT07625800). StuddyBuddy aggregates publicly available trial information.