B Cell Differentiation in MS | NCT03744351

Studies
B Cell Differentiation in MS

NCT03744351

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Apr 10, 2024Actual

Enrollment

136Actual

Phase

Not Applicable

Conditions

Multiple Sclerosis

Interventions

Biological Samples
Biological Samples
Biological Samples
Biological Samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2019Actual

Primary Completion Date

May 30, 2023Actual

Completion Date

May 30, 2023Actual

First Submitted Date

Nov 14, 2018

First Submission Date that Met QC Criteria

Nov 15, 2018

First Posted Date

Nov 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2024

Last Update Posted Date

Apr 10, 2024Actual

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy volunteer	Other	45 subjects A single visit	Other: Biological Samples
Clinically Isolated Syndrome	Other	• 35 subjects	Other: Biological Samples
Non-MS patients with neurological inflammatory disease	Other	• 30 subjects	Other: Biological Samples
MS patients (remitting or progressive untreated)	Other	30 untreated remittent patients 30 progressive untreated patients	Other: Biological Samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological Samples	Other	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).	Healthy volunteer

Measure	Description	Time Frame
Plasmablasts frequency	Frequency of plasmablasts CD38hiCD27hi obtained after 6 days of differentiation of B cells in vitro, analyzed by flow cytometry	At Day 6 after differentiation of B cells

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases