Switch to Ofatumumab and Level of Immunoglobulins

NCT07625800 | Not Yet Recruiting

• 2 other identifiers: 2024_07202025-A02557-42
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; NIS; Ofatumumab; Kesimpta; Ocrelizumab; IgG; IgM

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (16)

• Age at baseline (years)

  Baseline

• Number and percentage of patients with stable serum IgG levels

  24 months

• Number of severe infections occurring during ocrelizumab treatment period prior to switch to ofatumumab

  18 months

• Slope of serum immunoglobulin M (IgM) levels during ocrelizumab treatment period (minimum 18 months)

  24 months

• Distribution of Expanded Disability Status Scale (EDSS) scores after switch to ofatumumab

  24 months

Study Arms (1)

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

Drug: ofatumumab

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.

Ofatumumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be adult patients with MS (women and men) who initiate treatment with ofatumumab after a treatment with ocrelizumab

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHU de Lille

Lille, 59000, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

PATRICK VERMERSCH, Pr

CONTACT

06.33.38.32.60; patrick.vermersch@chu-lille.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

FR (1)