Switch to Ofatumumab and Level of Immunoglobulins

NCT07625800 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Lille

Phase

Observational

Started

2026-06

Last updated

2026-07-10

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

ofatumumab →

ofatumumab: There is no treatment allocation. Participants with MS that initiated treatment with ofatumumab (Kesimpta ®) as per neurologist practice and regardless of the study protocol.

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Slope of serum immunoglobulin G (IgG) levels during ocrelizumab treatment period (minimum 18 months) — 42 months
Slope of serum immunoglobulin G (IgG) levels during ofatumumab treatment period (24 months) — 42 months

Trial sites (1)

Facility	City	Region	Status
CHU de Lille	Lille	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07625800 on ClinicalTrials.gov ↗ ← All trials in France