Switch to Ofatumumab and Level of Immunoglobulins

Sponsor
University Hospital, Lille
Study ID
NCT07625800
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ofatumumab — DRUG
    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 Details

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 Dates

First listed
Jun 4, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
115 participants (estimated)

Arms

  • Arm: Ofatumumab
    Adult patients (≥18 years) with relapsing multiple sclerosis treated with ocrelizumab for at least 18 months and already switched or switching from ocrelizumab to ofatumumab treatment

Primary Outcome Measure

Slope of serum immunoglobulin G (IgG) levels during ocrelizumab treatment period (minimum 18 months) [ Time Frame: 42 months ]

Central Contacts

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