Multiple Sclerosis4BLMSNCT03796611
Phenotypic and Functional Study of 4BL B Cells in Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis, run by University Hospital, Lille at 1 site in France.
Trial summary
Recent works highlight the B cells involvement in multiple sclerosis (MS) pathology but their role remains poorly understood. It was previously described that activated memory B cells called 4BL due to the increased expression of 4-1BBL, an activation marker, induce pro-inflammatory response by activating T CD8+… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2017to 24 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: MS patients and controls: healthy controls and patients having non-MS neurological inflammatory disease and patients having other non inflammatory neurological disease.
Who may be able to join
- MS defined by McDonald 2017 criteria with a disease duration of less than 1 year
- between 18 and 60 years old patients
- naïve of any immune therapy or steroid intake
- patients who signed consent to the study
- Inclusion Criteria for controls with inflammatory of non inflammatory neurological disease:
- patients who signed consent to the study
Show all 11Show fewer
- between 18 and 60 years old patients
- naïve of any steroid intake or immune therapy
- control who signed consent at transfusion center for their blood collect to be used for study
- between 18 and 60 years old patients
- naïve of any steroid intake or immune therapy
Who cannot join
- pregnancy or breast-feeding
- patients or controls unable to sign the consent or to consent
Trial locations and contacts
1 site in 1 country.
About this study
Recent works highlight the B cells involvement in multiple sclerosis (MS) pathology but their role remains poorly understood. It was previously described that activated memory B cells called 4BL due to the increased expression of 4-1BBL, an activation marker, induce pro-inflammatory response by activating T CD8+ lymphocytes. Those 4BL cells are also described in systemic inflammation in 80 years old people explaining the poor efficiency of vaccination in that sub population. Those 4BL cells can also induce anti-tumoral T cell response.
The hypothesize is that 4BL may induce a pathogenic inflammatory response in MS.
Read the detailed description
the aim to compare the proportion of peripheral (blood) 4 BL cells but also 4-BL cells in cerebro spinal fluid (CSF) in MS compared to healthy controls and to other inflammatory neurological disease but also non inflammatory neurological disease.
For all groups of patients and controls it will collect blood and CSF only once (at diagnosis time for patients).
Blood collect from healthy controls will come from transfusion volunteers and we won't have CSF from them.
For patients from the MS group, the blood collect will be sequential at diagnosis, 3, 6, 12 and 24 months after during the follow up.
In the blood and CSF we will evaluate:
- percentage of 4 BL cells. 4 BL cells are found using cytometric parameters
- capacity of 4 BL cells to induce inflammatory response in vitro: percentage of induced activated TCD8 proliferation after cell culture using extracellular and intracellular cytometric parameters
- Conditions
- Multiple Sclerosis
- Keywords
- immunology, B cells
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| multiple sclerosis patient | MS is defined according to McDonald criteria 2017. MS patients included have a disease duration of less than 1 year | |
| other neurological inflammatory disease | autoimmune encephalitis, myasthenia gravis, chronic inflammatory demyelinating polyradiculitis | |
| neurological non inflammatory disease | benign intracranial hypertension, degenerative disorder | |
| healthy controls | transfusion volunteers from transfusion center |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of 4 BL cells in blood between MS patients and healthy controls
4 BL are defined using cytometric parameters
Measured: Baseline: one session
Secondary outcomes (3)
the percentage of 4 BL cells in blood between MS patients and patients with inflammatory and non inflammatory neurological disease
4 BL are defined using cytometric parameters
Measured: Baseline: one session
the percentage of 4 BL cells in CSF between MS patients and patients with inflammatory and non inflammatory neurological disease
4 BL are defined using cytometric parameters
Measured: Baseline: one session
to analyse over time the evolution of 4BL percentages in blood in MS patients
4 BL are defined using cytometric parameters
Measured: 5 blood collection at baseline, 3, 6, 12, and 24 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start24 Jul 2017
- Primary completion24 Aug 2017
- Study completion24 Aug 2017
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène ZEPHIR, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796611
- Sponsor's protocol ID
- 2016_04
- Other IDs
- 2017-A00835-48
- Acronym
- 4BLMS
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2019
- Last updated
- 5 May 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Functional Study of 4BL B Cells in Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT03796611
- Acronym / sponsor ID
- 4BLMS / 2016_04
- Conditions
- Multiple Sclerosis
- Keywords
- immunology, B cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 8 Jan 2019 (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.
Recent works highlight the B cells involvement in multiple sclerosis (MS) pathology but their role remains poorly understood. It was previously described that activated memory B cells called 4BL due to the increased expression of 4-1BBL, an activation marker, induce pro-inflammatory response by activating T CD8+ lymphocytes. Those 4BL cells are also described in systemic inflammation in 80 years old people explaining the poor efficiency of vaccination in that sub population. Those 4BL cells can also induce anti-tumoral T cell response.
The hypothesize is that 4BL may induce a pathogenic inflammatory response in MS.
Detailed description
the aim to compare the proportion of peripheral (blood) 4 BL cells but also 4-BL cells in cerebro spinal fluid (CSF) in MS compared to healthy controls and to other inflammatory neurological disease but also non inflammatory neurological disease.
For all groups of patients and controls it will collect blood and CSF only once (at diagnosis time for patients).
Blood collect from healthy controls will come from transfusion volunteers and we won't have CSF from them.
For patients from the MS group, the blood collect will be sequential at diagnosis, 3, 6, 12 and 24 months after during the follow up.
In the blood and CSF we will evaluate:
- percentage of 4 BL cells. 4 BL cells are found using cytometric parameters
- capacity of 4 BL cells to induce inflammatory response in vitro: percentage of induced activated TCD8 proliferation after cell culture using extracellular and intracellular cytometric parameters
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| multiple sclerosis patient | – | –MS is defined according to McDonald criteria 2017. MS patients included have a disease duration of less than 1 year |
| other neurological inflammatory disease | – | –autoimmune encephalitis, myasthenia gravis, chronic inflammatory demyelinating polyradiculitis |
| neurological non inflammatory disease | – | –benign intracranial hypertension, degenerative disorder |
| healthy controls | – | –transfusion volunteers from transfusion center |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- MS patients and controls: healthy controls and patients having non-MS neurological inflammatory disease and patients having other non inflammatory neurological disease.
Key inclusion criteria (11 listed)
- MS defined by McDonald 2017 criteria with a disease duration of less than 1 year
- between 18 and 60 years old patients
- naïve of any immune therapy or steroid intake
- patients who signed consent to the study
- Inclusion Criteria for controls with inflammatory of non inflammatory neurological disease:
Key exclusion criteria (2 listed)
- pregnancy or breast-feeding
- patients or controls unable to sign the consent or to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the percentage of 4 BL cells in blood between MS patients and healthy controls
Time frame: Baseline: one session
4 BL are defined using cytometric parameters
3 secondary outcomes
the percentage of 4 BL cells in blood between MS patients and patients with inflammatory and non inflammatory neurological disease
Time frame: Baseline: one session
the percentage of 4 BL cells in CSF between MS patients and patients with inflammatory and non inflammatory neurological disease
Time frame: Baseline: one session
to analyse over time the evolution of 4BL percentages in blood in MS patients
Time frame: 5 blood collection at baseline, 3, 6, 12, and 24 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 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. This study is not recruiting at the moment.
Hélène ZEPHIR, MD, PhD principal investigator
University Hospital, Lille
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 11 inclusion and 2 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: finished, as of the sponsor's last update on 5 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of 4 BL cells in blood between MS patients and healthy controls (time frame: Baseline: one session). 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 5 May 2026.