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NCT Number: NCT04798651

Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux - service de neurologie

Bordeaux, France

Location status: Recruiting

Location contact

Aurélie RUET, Prof

CONTACT

[email protected]

Aurélie RUET, Prof

PRINCIPAL_INVESTIGATOR

Jean-Christophe OUALLET, MD

SUB_INVESTIGATOR

Louis NADAL, MD

SUB_INVESTIGATOR

Pauline BUISSONNIERE, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood sample

Biological

28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

cerebro-spinal fluid

Biological

1 ml of cerebro-spinal fluid

Primary outcomes

  1. Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients.

    Time frame: At inclusion (day 0)

Secondary outcomes

  1. Quantification of disease activity scores

    Time frame: At inclusion (day 0)

    Expanded Disability Status Scale (EDSS)

  2. Quantification of disease activity scores

    Time frame: At inclusion (day 0)

    ambulation test

  3. Number of lesions

    Time frame: At inclusion (day 0)

    evaluated by MRI

  4. Size of lesions

    Time frame: At inclusion (day 0)

    evaluated by MRI

  5. Localisation of lesions

    Time frame: At inclusion (day 0)

    evaluated by MRI

  6. Types of lesions

    Time frame: At inclusion (day 0)

    evaluated by MRI

  7. duration of the disease

    Time frame: At inclusion (day 0)

  8. age at onset and progression

    Time frame: At inclusion (day 0)

  9. number of relapses

    Time frame: At inclusion (day 0)

  10. date of relapses

    Time frame: At inclusion (day 0)

  11. Treatment

    Time frame: At inclusion (day 0)

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie RUET, Prof

CONTACT

[email protected]

05 56 79 55 21 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • University of Bordeaux

Registry information

Acronym: T4MS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2021
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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