Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis (T4MS)

The study aims at identifying the type of B and CD4 T cell subsets with pathogenic properties in the different clinical forms of multiple sclerosis. This research might open new therapeutic approaches for the treatment of multiple sclerosis particularly progressive MS.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Clinically Isolated Syndrome
• Intervention / Treatment: Biological: blood sample; Biological: cerebro-spinal fluid

Detailed Description

Multiple sclerosis (MS) is a chronic autoimmune disease damaging the central nervous system (CNS). MS is categorized into several distinct forms according to clinical symptoms and medical examinations. Relapsing-remitting multiple sclerosis (RRMS) is characterized by attacks of worsening neurologic function, followed by partial or complete recovery periods. Patients can also present a gradual but steady progression of the disease (progressive forms). While several treatment options are currently available, no treatment completely stops the disease progression. Therefore, a deeper understanding regarding the mechanism of the disease development is essential to generate more efficient treatment strategies. CD4 T cells are known to be significantly involved in the formation of the CNS lesions characteristic of MS.The investigators hypothesize that different types of B and CD4 T cells play major roles in different forms of the disease. They will determine the phenotype and functions of the cells from the immune system particularly B and CD4 T cells present in the blood and cerebro-spinal fluid (CSF) of patients diagnosed with multiple sclerosis or presenting a clinically isolated syndrome.

The study will recruit 150 patients followed in Bordeaux University Hospital and diagnosed for clinically isolated syndrome (CIS) or multiple sclerosis (MS). Blood and CSF will be collected during a scheduled visit to study the properties of cells from the immune system in particular CD4 T cells in multiple sclerosis. Clinical and biological disease activity, treatment and outcomes will be studied in correlation with the properties of blood and CSF lymphocytes. No extra visit will be needed and the blood and CSF samples will be collected at the same times as those collected for clinical purposes.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurélie RUET, Prof; Phone Number: +33 05 56 79 55 21; Email: aurelie.ruet@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • CHU de Bordeaux - Service de neurologie
    • Principal Investigator: Aurélie RUET, Prof
    • Sub-Investigator: Jean-Christophe OUALLET, MD
    • Contact: Aurélie RUET, Prof; Email: aurelie.ruet@chu-bordeaux.fr
    • Sub-Investigator: Pauline BUISSONNIERE, MD
    • Sub-Investigator: Louis NADAL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• male or female subjects ;
• Age ≥ 18 years;
• subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome;
• patients for which a blood draw and / or lumbar puncture to collect CSF is performed for diagnostic or therapeutic purpose;
• affiliated to an health insurance system;
• and who agree to participate in the study.

Exclusion Criteria:

• Pregnant or breastfeeding women,
• patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with multiple sclerosis or clinically isolated syndrome; subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome	Biological: blood sample; 28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation; Biological: cerebro-spinal fluid; 1 ml of cerebro-spinal fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients.	At inclusion (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of disease activity scores	Expanded Disability Status Scale (EDSS)	At inclusion (day 0)
Quantification of disease activity scores	ambulation test	At inclusion (day 0)
Number of lesions	evaluated by MRI	At inclusion (day 0)
Size of lesions	evaluated by MRI	At inclusion (day 0)
Localisation of lesions	evaluated by MRI	At inclusion (day 0)
Types of lesions	evaluated by MRI	At inclusion (day 0)
duration of the disease		At inclusion (day 0)
age at onset and progression		At inclusion (day 0)
number of relapses		At inclusion (day 0)
date of relapses		At inclusion (day 0)
Treatment		At inclusion (day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: University of Bordeaux
• Investigators: Study Director: Nathalie SCHMITT, PhD, University of Bordeaux; Principal Investigator: Aurélie RUET, Prof, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Multiple sclerosis; B cells; Autoimmune Diseases of the Nervous System; lymphoid cells; clinically isolated syndrome; CD4 T cells
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Demyelinating Diseases; Multiple Sclerosis; Autoimmune Diseases of the Nervous System; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: CHUBX 2020/71

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No