Clinical trial NCT04798651: Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
Official title: Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Clinically Isolated Syndrome
Keywords: Autoimmune Diseases of the Nervous System
Multiple sclerosis
clinically isolated syndrome
lymphoid cells
CD4 T cells
B cells
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: University of Bordeaux
First posted: 2021-03-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients.
timeFrame: At inclusion (day 0)
Secondary outcomes:
measure: Quantification of disease activity scores
timeFrame: At inclusion (day 0)
measure: Quantification of disease activity scores
timeFrame: At inclusion (day 0)
measure: Number of lesions
timeFrame: At inclusion (day 0)
measure: Size of lesions
timeFrame: At inclusion (day 0)
measure: Localisation of lesions
timeFrame: At inclusion (day 0)
measure: Types of lesions
timeFrame: At inclusion (day 0)
measure: duration of the disease
timeFrame: At inclusion (day 0)
measure: age at onset and progression
timeFrame: At inclusion (day 0)
measure: number of relapses
timeFrame: At inclusion (day 0)
measure: date of relapses
timeFrame: At inclusion (day 0)
measure: Treatment
timeFrame: At inclusion (day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - service de neurologie
Study officials:
affiliation: University Hospital, Bordeaux
name: Aurélie RUET, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bordeaux
name: Nathalie SCHMITT, PhD
role: STUDY_DIRECTOR
References: