Multiple SclerosisABCD-SEPNCT03744351
B Cell Differentiation in MS
A study testing Biological Samples in people with Multiple Sclerosis, run by Rennes University Hospital at 1 site in France.
Trial summary
Interventional study with minimal risks and constraints, prospective, monocentric. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Biological Samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2019to 30 May 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Regarding MS patients (remitting or progressive untreated):
- Adult (age greater than or equal to 18 years) of both sexes;
- MS fulfilling the criteria of McDonald 2017;
- Remittent or progressive form;
- No immunomodulatory or immunosuppressive therapy for at least 3 months;
- Free, informed and written consent signed by the patient.
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- Regarding Clinically Isolated Syndrome:
- Adult (age greater than or equal to 18 years) of both sexes;
- Clinically isolated syndrome suggestive of MS (at least two typical lesions in two different locations);
- Patient receiving a Lumbar Puncture (PL) for diagnostic purposes;
- No immunomodulatory or immunosuppressive therapy for at least 3 months;
- Free, informed and written consent signed by the patient.
- Regarding non-MS patients with neurological inflammatory disease:
- Adult (age greater than or equal to 18 years) of both sexes;
- Patient with non-MS neurological inflammatory disease (examples: meningitis, neurolupus, neurosarcoidosis...);
- Patients with PL for diagnostic or surveillance purposes;
- No immunomodulatory or immunosuppressive therapy for at least 3 months;
- Free, informed and written consent signed by the patient.
- Regarding healthy volunteers:
- Adult (age greater than or equal to 18 years) of both sexes;
- Free, informed and written consent signed by the volunteer.
Who cannot join
- Regarding all patients:
- Pregnancy;
- Breastfeeding;
- Treatment with corticotherapy in the last month;
- Patient not affiliated to social security;
- Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.
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- Regarding healthy volunteers:
- Pregnancy;
- Breastfeeding;
- Not affiliated to social security;
- Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of B Cell Differentiation in Multiple Sclerosis
Interventional study with minimal risks and constraints, prospective, monocentric.
Read the detailed description
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the Central Nervous System (CNS) affecting primarily young adults. This disease is the leading cause of non-traumatic disability in this population.
MS has long been considered as a T-cell mediated disease. However, the remarkable efficacy of anti-CD20 monoclonal antibodies in this disease has highlighted the major role of B-lymphocytes in the pathophysiology of this disease.
Despite many advances made recently in understanding the role of B-lymphocytes in the pathophysiology of MS, the precise involvement of plasma cells and their function at different stages of the disease remains unclear. In this project, the investigators plan to analyze the differentiation abilities of circulating B-lymphocytes in patients with MS.
Follicular helper T cells (TFH) play a crucial role in B lymphocyte differentiation. These cells are located within germinal centers in secondary lymphoid organs, and their memory compartment also circulates in the blood. Several circulating TFH subpopulations have recently been defined, with different helping capacities. There is currently very little data on these cells in MS patients. The investigators therefore plan, in a second step, to characterize the phenotype of the different subpopulations of TFH at the periphery, but also in the CSF of MS patients.
- Conditions
- Multiple Sclerosis
- Being tested
- Biological Samples
- Keywords
- Follicular helper T cells, B cells, Differentiation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological SamplesOther
Venous sampling that is performed solely for the purpose of research. The total blood volume taken is 80 ml maximum (8 tubes of 10 ml).
Biological SamplesOther
Eight additional 10 ml tubes of blood and an additional 5 ml CSF tube will be taken from the patient during a sample taken for the patient's usual check-up /follow-up.
Inpatients will also be offered stool removal.
Biological SamplesOther
The patient will be taken 8 additional tubes of 10 ml of blood (during a blood test performed for the usual assessment of the patient) and an additional 5 ml of CSF in a sample taken for the assessment of the patient.
Biological SamplesOther
Eight additional 10 ml tubes of blood will be taken from the patient during a sample taken for the patient's usual check-up / follow-up.
Inpatients will also be offered stool removal
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Other | * 45 subjects
* A single visit Receives: Other: Biological Samples |
| Clinically Isolated Syndrome | Other | • 35 subjects Receives: Other: Biological Samples |
| Non-MS patients with neurological inflammatory disease | Other | • 30 subjects Receives: Other: Biological Samples |
| MS patients (remitting or progressive untreated) | Other | * 30 untreated remittent patients
* 30 progressive untreated patients Receives: Other: Biological Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmablasts frequency
Frequency of plasmablasts CD38hiCD27hi obtained after 6 days of differentiation of B cells in vitro, analyzed by flow cytometry
Measured: At Day 6 after differentiation of B cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start25 Feb 2019
- Primary completion30 May 2023
- Study completion30 May 2023
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure Michel, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744351
- Sponsor's protocol ID
- 35RC18_8909_ABCD-SEP
- Acronym
- ABCD-SEP
- Status last verified
- Apr 2024
- First submitted
- 14 Nov 2018
- Last updated
- 10 Apr 2024
- 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of B Cell Differentiation in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03744351
- Acronym / sponsor ID
- ABCD-SEP / 35RC18_8909_ABCD-SEP
- Conditions
- Multiple Sclerosis
- Keywords
- Follicular helper T cells, B cells, Differentiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 16 Nov 2018 (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.
Interventional study with minimal risks and constraints, prospective, monocentric.
Detailed description
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the Central Nervous System (CNS) affecting primarily young adults. This disease is the leading cause of non-traumatic disability in this population.
MS has long been considered as a T-cell mediated disease. However, the remarkable efficacy of anti-CD20 monoclonal antibodies in this disease has highlighted the major role of B-lymphocytes in the pathophysiology of this disease.
Despite many advances made recently in understanding the role of B-lymphocytes in the pathophysiology of MS, the precise involvement of plasma cells and their function at different stages of the disease remains unclear. In this project, the investigators plan to analyze the differentiation abilities of circulating B-lymphocytes in patients with MS.
Follicular helper T cells (TFH) play a crucial role in B lymphocyte differentiation. These cells are located within germinal centers in secondary lymphoid organs, and their memory compartment also circulates in the blood. Several circulating TFH subpopulations have recently been defined, with different helping capacities. There is currently very little data on these cells in MS patients. The investigators therefore plan, in a second step, to characterize the phenotype of the different subpopulations of TFH at the periphery, but also in the CSF of MS patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Other | Other: Biological Samples* 45 subjects * A single visit |
| Clinically Isolated Syndrome | Other | Other: Biological Samples• 35 subjects |
| Non-MS patients with neurological inflammatory disease | Other | Other: Biological Samples• 30 subjects |
| MS patients (remitting or progressive untreated) | Other | Other: Biological Samples* 30 untreated remittent patients * 30 progressive untreated patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Adult (age greater than or equal to 18 years) of both sexes;
- MS fulfilling the criteria of McDonald 2017;
- Remittent or progressive form;
- No immunomodulatory or immunosuppressive therapy for at least 3 months;
- Free, informed and written consent signed by the patient.
Key exclusion criteria (11 listed)
- Pregnancy;
- Breastfeeding;
- Treatment with corticotherapy in the last month;
- Patient not affiliated to social security;
- Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.
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 |
|---|---|---|
| Biological SamplesVenous sampling that is performed solely for the purpose of research. The total blood volume taken is 80 ml maximum (8 tubes of 10 ml). | Other | Healthy volunteer |
| Biological SamplesEight additional 10 ml tubes of blood and an additional 5 ml CSF tube will be taken from the patient during a sample taken for the patient's usual check-up /follow-up. Inpatients will also be offered stool removal. | Other | Clinically Isolated Syndrome |
| Biological SamplesThe patient will be taken 8 additional tubes of 10 ml of blood (during a blood test performed for the usual assessment of the patient) and an additional 5 ml of CSF in a sample taken for the assessment of the patient. | Other | Non-MS patients with neurological inflammatory disease |
| Biological SamplesEight additional 10 ml tubes of blood will be taken from the patient during a sample taken for the patient's usual check-up / follow-up. Inpatients will also be offered stool removal | Other | MS patients (remitting or progressive untreated) |
Primary outcome
Plasmablasts frequency
Time frame: At Day 6 after differentiation of B cells
Frequency of plasmablasts CD38hiCD27hi obtained after 6 days of differentiation of B cells in vitro, analyzed by flow cytometry
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 10 Apr 2024.
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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.
Laure Michel principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological Samples in people with Multiple Sclerosis, run by Rennes University Hospital 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 21 inclusion and 11 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 10 Apr 2024. 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?
Plasmablasts frequency (time frame: At Day 6 after differentiation of B cells). 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 10 Apr 2024; AzTrials last refreshed its copy on 28 Oct 2026.