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CompletedNCT03744351ABCD-SEPUpdated Apr 10, 2024

B Cell Differentiation in MS

An interventional study of Biological Samples and Biological Samples in Multiple Sclerosis, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.

Sponsored by Rennes University Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Sclerosis

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Keywords

  • Follicular helper T cells
  • B cells
  • Differentiation
03

In context

Multiple Sclerosis

3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.

This study's enrollment of 136 is above the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

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

Exclusion Criteria:

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.

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
136 participants (actual)

Study arms

  • Other
    Healthy volunteer

    * 45 subjects * A single visit

    Other: Biological Samples

  • Other
    Clinically Isolated Syndrome

    • 35 subjects

    Other: Biological Samples

  • Other
    Non-MS patients with neurological inflammatory disease

    • 30 subjects

    Other: Biological Samples

  • Other
    MS patients (remitting or progressive untreated)

    * 30 untreated remittent patients * 30 progressive untreated patients

    Other: Biological Samples

Interventions

  • OtherBiological 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).

  • OtherBiological 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.

  • OtherBiological 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.

  • OtherBiological 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

06

What researchers measure

Primary outcomes

  1. Plasmablasts frequency

    Frequency of plasmablasts CD38hiCD27hi obtained after 6 days of differentiation of B cells in vitro, analyzed by flow cytometry

    Time frame: At Day 6 after differentiation of B cells

07

Study locations

1 site
  • Rennes University Hospital
    Rennes, 35033, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03744351
Responsible party
Sponsor
First posted
Nov 16, 2018
Start date
Feb 25, 2019
Primary completion
May 30, 2023
Completion
May 30, 2023
Last update
Apr 10, 2024

Study contacts

Laure Michel
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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