Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2019-02-25
2023-05-30
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Healthy volunteer
* 45 subjects
* A single visit
Biological Samples
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).
Clinically Isolated Syndrome
• 35 subjects
Biological Samples
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.
Non-MS patients with neurological inflammatory disease
• 30 subjects
Biological Samples
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.
MS patients (remitting or progressive untreated)
* 30 untreated remittent patients
* 30 progressive untreated patients
Biological Samples
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
Interventions
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Biological Samples
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 Samples
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 Samples
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 Samples
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
Eligibility Criteria
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Inclusion Criteria
* 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.
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.
Exclusion Criteria
* 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.
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.
18 Years
ALL
Yes
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Laure Michel
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
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Rennes University Hospital
Rennes, , France
Countries
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Other Identifiers
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35RC18_8909_ABCD-SEP
Identifier Type: -
Identifier Source: org_study_id
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