Switch to Ofatumumab and Level of Immunoglobulins
ConditionMultiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity Hospital, Lille
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- ofatumumab
Treatment groups
115 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov