Multiple SclerosisSOLINCT07625800
Switch to Ofatumumab and Level of Immunoglobulins
An observational study of Multiple Sclerosis, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ofatumumab
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2026to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be adult patients with MS (women and men) who initiate treatment with ofatumumab after a treatment with ocrelizumab
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Lille
Lille, 59000
Patrick VERMERSCH, Dr, 06.33.38.32.60, patrick.vermersch@chu-lille.fr
About this study
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.
Read the detailed description
time perspective: retrospective and prospective
- Conditions
- Multiple Sclerosis
- Being tested
- ofatumumab
- Keywords
- Multiple Sclerosis, NIS, Ofatumumab, Kesimpta, Ocrelizumab, IgG, IgM
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ofatumumabDrug
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of serum immunoglobulin G (IgG) levels during ocrelizumab treatment period (minimum 18 months)
Measured: 42 months
Slope of serum immunoglobulin G (IgG) levels during ofatumumab treatment period (24 months)
Measured: 42 months
Secondary outcomes (16)
Age at baseline (years)
Measured: Baseline
Number and percentage of patients with stable serum IgG levels
Measured: 24 months
Number of severe infections occurring during ocrelizumab treatment period prior to switch to ofatumumab
Measured: 18 months
Slope of serum immunoglobulin M (IgM) levels during ocrelizumab treatment period (minimum 18 months)
Measured: 24 months
Distribution of Expanded Disability Status Scale (EDSS) scores after switch to ofatumumab
Expanded Disability Status Scale (EDSS): score range 0-10, where higher scores indicate greater neurological disability (worse outcome).
Measured: 24 months
Number of patients who discontinued ofatumumab before the end of follow-up
Measured: 24 months
Number and type of adverse events (AEs) during ofatumumab follow-up period
Measured: 24 months
Disease duration (years since diagnosis)
Measured: Baseline
Sex distribution (male/female, percentage of patients)
Measured: Baseline
Number and percentage of patients with increased serum IgG levels
Measured: 24 months
Slope of serum immunoglobulin M (IgM) levels during ofatumumab treatment period (24 months)
Measured: 24 months
Distribution of Fatigue Severity Scale (FSS) scores after switch to ofatumumab
Fatigue Severity Scale (FSS): score range 9-63, where higher scores indicate greater fatigue severity (worse outcome).
Measured: 24 months
Distribution of Multiple Sclerosis Functional Composite (MSFC) scores after switch to ofatumumab
Multiple Sclerosis Functional Composite (MSFC): standardized composite score (z-score), with higher scores indicating better neurological function (better outcome).
Measured: 24 months
Number of relapses per patient after switch to ofatumumab
Measured: 24 months
Reasons for discontinuation of ofatumumab before the end of follow-up
Measured: 24 months
Number and type of serious adverse events (SAEs) during ofatumumab follow-up period
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start12 Oct 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625800
- Sponsor's protocol ID
- 2024_0720
- Other IDs
- 2025-A02557-42
- Acronym
- SOLI
- Status last verified
- Oct 2026
- First submitted
- 15 May 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch to Ofatumumab and Level of Immunoglobulins
- ClinicalTrials.gov ID
- NCT07625800
- Acronym / sponsor ID
- SOLI / 2024_0720
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, NIS, Ofatumumab, Kesimpta, Ocrelizumab, IgG, IgM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 12 Oct 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
time perspective: retrospective and prospective
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab | – | Drug: ofatumumabAdult 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be adult patients with MS (women and men) who initiate treatment with ofatumumab after a treatment with ocrelizumab
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ofatumumabThere is no treatment allocation. Participants with MS that initiated treatment with ofatumumab (Kesimpta ®) as per neurologist practice and regardless of the study protocol. | Drug | Ofatumumab |
Primary outcome
Slope of serum immunoglobulin G (IgG) levels during ocrelizumab treatment period (minimum 18 months)
Time frame: 42 months
Slope of serum immunoglobulin G (IgG) levels during ofatumumab treatment period (24 months)
Time frame: 42 months
16 secondary outcomes
Age at baseline (years)
Time frame: Baseline
Number and percentage of patients with stable serum IgG levels
Time frame: 24 months
Number of severe infections occurring during ocrelizumab treatment period prior to switch to ofatumumab
Time frame: 18 months
Slope of serum immunoglobulin M (IgM) levels during ocrelizumab treatment period (minimum 18 months)
Time frame: 24 months
Distribution of Expanded Disability Status Scale (EDSS) scores after switch to ofatumumab
Time frame: 24 months
Number of patients who discontinued ofatumumab before the end of follow-up
Time frame: 24 months
Number and type of adverse events (AEs) during ofatumumab follow-up period
Time frame: 24 months
Disease duration (years since diagnosis)
Time frame: Baseline
Sex distribution (male/female, percentage of patients)
Time frame: Baseline
Number and percentage of patients with increased serum IgG levels
Time frame: 24 months
Slope of serum immunoglobulin M (IgM) levels during ofatumumab treatment period (24 months)
Time frame: 24 months
Distribution of Fatigue Severity Scale (FSS) scores after switch to ofatumumab
Time frame: 24 months
Distribution of Multiple Sclerosis Functional Composite (MSFC) scores after switch to ofatumumab
Time frame: 24 months
Number of relapses per patient after switch to ofatumumab
Time frame: 24 months
Reasons for discontinuation of ofatumumab before the end of follow-up
Time frame: 24 months
Number and type of serious adverse events (SAEs) during ofatumumab follow-up period
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PATRICK VERMERSCH, Pr (06.33.38.32.60, patrick.vermersch@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slope of serum immunoglobulin G (IgG) levels during ocrelizumab treatment period (minimum 18 months) (time frame: 42 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.