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NCT Number: NCT07625800

Switch to Ofatumumab and Level of Immunoglobulins

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

time perspective: retrospective and prospective

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Slope of serum immunoglobulin G (IgG) levels during ocrelizumab treatment period (minimum 18 months)

    Time frame: 42 months

  2. Slope of serum immunoglobulin G (IgG) levels during ofatumumab treatment period (24 months)

    Time frame: 42 months

Secondary outcomes

  1. Age at baseline (years)

    Time frame: Baseline

  2. Number and percentage of patients with stable serum IgG levels

    Time frame: 24 months

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

    Time frame: 18 months

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

    Time frame: 24 months

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

    Time frame: 24 months

    Expanded Disability Status Scale (EDSS): score range 0-10, where higher scores indicate greater neurological disability (worse outcome).

  6. Number of patients who discontinued ofatumumab before the end of follow-up

    Time frame: 24 months

  7. Number and type of adverse events (AEs) during ofatumumab follow-up period

    Time frame: 24 months

  8. Disease duration (years since diagnosis)

    Time frame: Baseline

  9. Sex distribution (male/female, percentage of patients)

    Time frame: Baseline

  10. Number and percentage of patients with increased serum IgG levels

    Time frame: 24 months

  11. Slope of serum immunoglobulin M (IgM) levels during ofatumumab treatment period (24 months)

    Time frame: 24 months

  12. Distribution of Fatigue Severity Scale (FSS) scores after switch to ofatumumab

    Time frame: 24 months

    Fatigue Severity Scale (FSS): score range 9-63, where higher scores indicate greater fatigue severity (worse outcome).

  13. Distribution of Multiple Sclerosis Functional Composite (MSFC) scores after switch to ofatumumab

    Time frame: 24 months

    Multiple Sclerosis Functional Composite (MSFC): standardized composite score (z-score), with higher scores indicating better neurological function (better outcome).

  14. Number of relapses per patient after switch to ofatumumab

    Time frame: 24 months

  15. Reasons for discontinuation of ofatumumab before the end of follow-up

    Time frame: 24 months

  16. Number and type of serious adverse events (SAEs) during ofatumumab follow-up period

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

PATRICK VERMERSCH, Pr

CONTACT

[email protected]

06.33.38.32.60

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: SOLI

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 4, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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