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B Cell Differentiation in MS (ABCD-SEP)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological Samples
Biological Samples
Biological Samples
Biological Samples
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Follicular helper T cells, B cells, Differentiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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.

Sites / Locations

  • Rennes University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Healthy volunteer

Clinically Isolated Syndrome

Non-MS patients with neurological inflammatory disease

MS patients (remitting or progressive untreated)

Arm Description

45 subjects A single visit

• 35 subjects

• 30 subjects

30 untreated remittent patients 30 progressive untreated patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 14, 2018
Last Updated
December 8, 2022
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03744351
Brief Title
B Cell Differentiation in MS
Acronym
ABCD-SEP
Official Title
Analysis of B Cell Differentiation in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Follicular helper T cells, B cells, Differentiation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteer
Arm Type
Other
Arm Description
45 subjects A single visit
Arm Title
Clinically Isolated Syndrome
Arm Type
Other
Arm Description
• 35 subjects
Arm Title
Non-MS patients with neurological inflammatory disease
Arm Type
Other
Arm Description
• 30 subjects
Arm Title
MS patients (remitting or progressive untreated)
Arm Type
Other
Arm Description
30 untreated remittent patients 30 progressive untreated patients
Intervention Type
Other
Intervention Name(s)
Biological Samples
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Biological Samples
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Biological Samples
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Biological Samples
Intervention Description
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
Primary Outcome Measure Information:
Title
Plasmablasts frequency
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laure Michel
Phone
2 99 28 37 09
Ext
+33
Email
laure.michel@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuelle Le Page
Phone
2 99 28 37 09
Ext
+33
Email
emmanuelle.le.page@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laure Michel
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure Michel
Phone
2 99 28 37 09
Ext
+33
Email
laure.michel@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Emmanuelle Le Page
Phone
2 99 28 37 09
Ext
+33
Email
emmanuelle.le.page@chu-rennes.fr

12. IPD Sharing Statement

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B Cell Differentiation in MS

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