Multiple SclerosisB-MSNCT02789670
Analysis of the Distribution of Regulatory B Cells in Blood of Multiple Sclerosis Patients
An observational study of Multiple Sclerosis and Systemic Sclerosis, run by University Hospital, Lille at 1 site in France.
Trial summary
New therapeutic approaches of MS are emerging, targeting different actors of the immune system. Some of them target a specific population of white blood cells: B lymphocytes composed of different subpopulations. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Systemic Sclerosis
- What is being tested?
- Blood sample collection
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Apr 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Patients with MS criteria (McDonald et al. 2001) or with Clinically isolated syndrome (CIS) or radiologically isolated syndrome(RIS) or
- Patients patients with other neurological inflammatory disease (OIND) or with autoimmune disease without neurological disease Leroy Metsger' criteria of systemic sclerosis) (OID)
Who cannot join
- Women without reliable contraception
- Nursing women
- Patients having immunosuppressive treatment in the last month ( beta interféron, glatiramer acetate, natalizumab, fingolimod, glucocorticoid)
Trial locations and contacts
1 site in 1 country.
About this study
New therapeutic approaches of MS are emerging, targeting different actors of the immune system. Some of them target a specific population of white blood cells: B lymphocytes composed of different subpopulations. The subsets of B cells express different functional properties that control the immune response, but these regulation mechanisms have yet to be clearly described. Some subpopulations could amplify inflammation through IL-6 production for example, whereas some ones contribute to its regulation through the production of IL-10. Using samples collected in a large cohort of individuals with risk of MS and treatment-naive patients in the early onset of the disease, the investigators aim to develop a 2 year follow-up study of the different blood B cells subset distribution and their functional properties in terms of pro- and anti-inflammatory cytokine production in MS. This approach can identify new biomarkers for monitoring of MS patients and lead to better define the indication use of depletive B cell drugs and not to counteract the regulatory action of these cells.
Read the detailed description
Multiple sclerosis (MS) is a progressive immuno-inflammatory and degenerative disease of the central nervous system (CNS) and represents the second most common cause of disability in young people. The pathophysiologic mechanisms involved are complex and effective therapeutic strategies have yet to be defined. Moreover it's today evident that treatment approaches have to be performed in a personalized point of view. In this context, biomarkers evaluating the course of the disease but also predicting efficacy of therapy are particularly needed in MS.
Recent data underlines the direct role of B-cells in MS. Such comprehensive data have led to new therapeutic strategies using biotherapies in order to deplete, or modulate, the functions of peripheral B cells. Such approaches have led to contradictory results of efficacy. Today, it remains unclear whether B-cells exert diminished regulatory effects or instead potentiate the pathogenic response of T-cells. Such dual properties may depend on the release of inhibitory (e.g. interleukin-10) or pro-inflammatory cytokines (e.g. interleukin-6) and/or direct interactions with other cells, especially T cells.
The investigators aim to longitudinally evaluate quantitative and functional changes in peripheral blood B-cell subsets (1) at the initiation phases of MS, i.e. radiological isolated syndrome (RIS) and clinically isolated syndrome (CIS) (2) during progression of MS and (3) between the two clinical forms of MS in naïve treatment patient: Relapsing-Remittent MS (RRMS) and Primary Progressive MS (PPMS). B-cell subsets are defined by a combination of membrane markers and enumerated at different time points (inclusion (before treatment) and at 3, 6, 12, 24 months of treatment initiation) in a whole blood flow cytometric (FCM) analysis. The absolute counts and relative proportions of transitional, naïve, memory, and marginal zone-like B-cell subsets are being followed up prospectively in patients with a radiologically isolated syndrome (RIS, n= 20), with clinically isolated syndrome (CIS, n= 20), in MS patients with relapsing remitting form (RRMS, n = 20) and in MS patients with primary progressive evolution of the disease (PPMS, n = 20). Control samples are being collected from patients affected by other inflammatory diseases with neurological symptoms (Devic syndrome, Neurobehcet, neurosarcoidosis n = 20) or without neurological symptoms (systemic sclerosis, SSc, n= 20) and from blood donors (n = 40). In order to evaluate functional properties of B cells, peripheral blood mononuclear cells (PBMC) from each group of patients are activated with CD40 ligand and CpG Oligodeoxynucleotides (CpG ODNs), and IL-10-producing B-cells are enumerated by FCM after a brief incubation with phorbol myristate acetate, ionomycin, and brefeldin A as a protein transport inhibitor agent. In selected CIS and MS patients whose changes in B-cell subpopulations associated with onset or progression of the disease are representative, the B-cell subpopulations will be purified and activated with CD40 ligand and CpG ODNs to be co cultured with anti-CD3-activated autologous T-cells to evaluate inhibitory or potentiating effects on T-cell production of pro-inflammatory cytokines (e.g. IFN-gamma, IL-17).
All phenotypic analyses and cell cultures are performed using previously validated protocols. Our ultimate goal is to correlate quantitative and functional changes of subsets composing the systemic B-cell population with the grading and evolution of MS. Such a strategy could lead to identify which MS patients should receive treatment targeting B cells and when. Further, it may offer a rationale for alternative forms of cell therapy that could introduce for example autologous purified B regulator cells after depletive strategies.
- Conditions
- Multiple Sclerosis, Systemic Sclerosis
- Being tested
- Blood sample collection
- Medical subject headings
- Multiple Sclerosis, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
Peripheral blood will be collected in patients at the different time of the study to analyze phenotypic and functional properties of B cells in MS patients and control group
| Study group | Role | What they receive |
|---|---|---|
| MS patients | MS patient group is composed by 20 Individuals with inflammatory brain lesions seen in MRI (Radiologically Isolated syndrome) 20 patients with only one clinically isolated syndrome (CIS) 20 patients with relapsed remittent Multiple sclerosis (RRMS) 20 patients with primary progressive Multiple Sclerosis (PPMS) Receives: Other: Blood sample collection | |
| Control group patients | Control patient cohort is composed by 20 patients suffering from inflammatory neurological disease other than MS Devic syndrome, Neurosarcoidosis, Neurobehcet... (autoimmune disease control group with neurological disease) 20 patients with systemic sclerosis (autoimmune disease control group) without neurological disease)
40 healthy subjects Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the production of IL-10 and IL-6 by B cells in MS patients and the control group at inclusion time point
Percentage of B cells expressing intracellular IL-6 and/or IL-10 will be analyzed in MS patients versus controls at inclusion
Measured: inclusion
Secondary outcomes (7)
Comparison of the production of IL-10 and IL-6 by B cells in MS patients and the control group at the different time points of the study
Percentage of B cells expressing intracellular IL-6 and/or IL-10 will be analyzed in MS patients versus controls at the different time points
Measured: 3, 6, 12, 24 months
Comparison of the production of IL-10 and IL-6 by B cells in the MS patient subgroups at the inclusion time point
Percentage of B cells expressing intracellular IL-6 and/or IL-10 will be analyzed in the different MS patient subgroups at the inclusion time point
Measured: inclusion
Comparison of the production of IL-10 and IL-6 by B cells in the MS patient subgroups at the different time points of the study
Percentage of B cells expressing intracellular IL-6 and/or IL-10 will be analyzed in the different MS patient subgroups at the different time points
Measured: 3, 6, 12, 24 months
Comparison B cell subset distribution in MS patients and the control group
Distribution of B cell subsets (expressed in percentages) analyzed by flow cytometry in MS and the control group at inclusion time point
Measured: at inclusion
Comparison B cell subset distribution
Distribution of B cell subsets (expressed in absolute values) analyzed by flow cytometry in MS and the control group at inclusion time point
Measured: at inclusion
Comparison B cell subset distribution in MS patients versus the control group at the different time points of the study
Distribution of B cell subsets (expressed in percentages) analyzed by flow cytometry in MS and the control group at the different time points of the study
Measured: 3, 6, 12, 24 months
Comparison B cell subset distribution in MS patients versus the control group at the different time points of the study
Distribution of B cell subsets (absolute values) analyzed by flow cytometry in MS and the control group at the different time points of the study
Measured: 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startJul 2014
- Primary completionApr 2021
- Study completionApr 2021
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain DUBUCQUOI, MD PhD, Principal investigator, CHRU de LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789670
- Sponsor's protocol ID
- 2013_35
- Other IDs
- 2014-A00248-39
- Acronym
- B-MS
- Status last verified
- Sep 2020
- First submitted
- 12 May 2016
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Distribution of Regulatory B Cells in Blood of Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT02789670
- Acronym / sponsor ID
- B-MS / 2013_35
- Conditions
- Multiple Sclerosis, Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 3 Jun 2016 (estimated)
- 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.
New therapeutic approaches of MS are emerging, targeting different actors of the immune system. Some of them target a specific population of white blood cells: B lymphocytes composed of different subpopulations. The subsets of B cells express different functional properties that control the immune response, but these regulation mechanisms have yet to be clearly described. Some subpopulations could amplify inflammation through IL-6 production for example, whereas some ones contribute to its regulation through the production of IL-10. Using samples collected in a large cohort of individuals with risk of MS and treatment-naive patients in the early onset of the disease, the investigators aim to develop a 2 year follow-up study of the different blood B cells subset distribution and their functional properties in terms of pro- and anti-inflammatory cytokine production in MS. This approach can identify new biomarkers for monitoring of MS patients and lead to better define the indication use of depletive B cell drugs and not to counteract the regulatory action of these cells.
Detailed description
Multiple sclerosis (MS) is a progressive immuno-inflammatory and degenerative disease of the central nervous system (CNS) and represents the second most common cause of disability in young people. The pathophysiologic mechanisms involved are complex and effective therapeutic strategies have yet to be defined. Moreover it's today evident that treatment approaches have to be performed in a personalized point of view. In this context, biomarkers evaluating the course of the disease but also predicting efficacy of therapy are particularly needed in MS.
Recent data underlines the direct role of B-cells in MS. Such comprehensive data have led to new therapeutic strategies using biotherapies in order to deplete, or modulate, the functions of peripheral B cells. Such approaches have led to contradictory results of efficacy. Today, it remains unclear whether B-cells exert diminished regulatory effects or instead potentiate the pathogenic response of T-cells. Such dual properties may depend on the release of inhibitory (e.g. interleukin-10) or pro-inflammatory cytokines (e.g. interleukin-6) and/or direct interactions with other cells, especially T cells.
The investigators aim to longitudinally evaluate quantitative and functional changes in peripheral blood B-cell subsets (1) at the initiation phases of MS, i.e. radiological isolated syndrome (RIS) and clinically isolated syndrome (CIS) (2) during progression of MS and (3) between the two clinical forms of MS in naïve treatment patient: Relapsing-Remittent MS (RRMS) and Primary Progressive MS (PPMS). B-cell subsets are defined by a combination of membrane markers and enumerated at different time points (inclusion (before treatment) and at 3, 6, 12, 24 months of treatment initiation) in a whole blood flow cytometric (FCM) analysis. The absolute counts and relative proportions of transitional, naïve, memory, and marginal zone-like B-cell subsets are being followed up prospectively in patients with a radiologically isolated syndrome (RIS, n= 20), with clinically isolated syndrome (CIS, n= 20), in MS patients with relapsing remitting form (RRMS, n = 20) and in MS patients with primary progressive evolution of the disease (PPMS, n = 20). Control samples are being collected from patients affected by other inflammatory diseases with neurological symptoms (Devic syndrome, Neurobehcet, neurosarcoidosis n = 20) or without neurological symptoms (systemic sclerosis, SSc, n= 20) and from blood donors (n = 40). In order to evaluate functional properties of B cells, peripheral blood mononuclear cells (PBMC) from each group of patients are activated with CD40 ligand and CpG Oligodeoxynucleotides (CpG ODNs), and IL-10-producing B-cells are enumerated by FCM after a brief incubation with phorbol myristate acetate, ionomycin, and brefeldin A as a protein transport inhibitor agent. In selected CIS and MS patients whose changes in B-cell subpopulations associated with onset or progression of the disease are representative, the B-cell subpopulations will be purified and activated with CD40 ligand and CpG ODNs to be co cultured with anti-CD3-activated autologous T-cells to evaluate inhibitory or potentiating effects on T-cell production of pro-inflammatory cytokines (e.g. IFN-gamma, IL-17).
All phenotypic analyses and cell cultures are performed using previously validated protocols. Our ultimate goal is to correlate quantitative and functional changes of subsets composing the systemic B-cell population with the grading and evolution of MS. Such a strategy could lead to identify which MS patients should receive treatment targeting B cells and when. Further, it may offer a rationale for alternative forms of cell therapy that could introduce for example autologous purified B regulator cells after depletive strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS patients | – | Other: Blood sample collectionMS patient group is composed by 20 Individuals with inflammatory brain lesions seen in MRI (Radiologically Isolated syndrome) 20 patients with only one clinically isolated syndrome (CIS) 20 patients with relapsed remittent Multiple sclerosis (RRMS) 20 patients with primary progressive Multiple Sclerosis (PPMS) |
| Control group patients | – | Other: Blood sample collectionControl patient cohort is composed by 20 patients suffering from inflammatory neurological disease other than MS Devic syndrome, Neurosarcoidosis, Neurobehcet... (autoimmune disease control group with neurological disease) 20 patients with systemic sclerosis (autoimmune disease control group) without neurological disease) 40 healthy subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- Patients with MS criteria (McDonald et al. 2001) or with Clinically isolated syndrome (CIS) or radiologically isolated syndrome(RIS) or
- Patients patients with other neurological inflammatory disease (OIND) or with autoimmune disease without neurological disease Leroy Metsger' criteria of systemic sclerosis) (OID)
Key exclusion criteria (3 listed)
- Women without reliable contraception
- Nursing women
- Patients having immunosuppressive treatment in the last month ( beta interféron, glatiramer acetate, natalizumab, fingolimod, glucocorticoid)
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 |
|---|---|---|
| Blood sample collectionPeripheral blood will be collected in patients at the different time of the study to analyze phenotypic and functional properties of B cells in MS patients and control group | Other | Control group patients, MS patients |
Primary outcome
Comparison of the production of IL-10 and IL-6 by B cells in MS patients and the control group at inclusion time point
Time frame: inclusion
Percentage of B cells expressing intracellular IL-6 and/or IL-10 will be analyzed in MS patients versus controls at inclusion
7 secondary outcomes
Comparison of the production of IL-10 and IL-6 by B cells in MS patients and the control group at the different time points of the study
Time frame: 3, 6, 12, 24 months
Comparison of the production of IL-10 and IL-6 by B cells in the MS patient subgroups at the inclusion time point
Time frame: inclusion
Comparison of the production of IL-10 and IL-6 by B cells in the MS patient subgroups at the different time points of the study
Time frame: 3, 6, 12, 24 months
Comparison B cell subset distribution in MS patients and the control group
Time frame: at inclusion
Comparison B cell subset distribution
Time frame: at inclusion
Comparison B cell subset distribution in MS patients versus the control group at the different time points of the study
Time frame: 3, 6, 12, 24 months
Comparison B cell subset distribution in MS patients versus the control group at the different time points of the study
Time frame: 3, 6, 12, 24 months
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 14 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Sylvain DUBUCQUOI, MD PhD principal investigator
CHRU de 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 and Systemic 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 2 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: finished, as of the sponsor's last update on 14 Oct 2022. 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?
Comparison of the production of IL-10 and IL-6 by B cells in MS patients and the control group at inclusion time point (time frame: inclusion). 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 14 Oct 2022.