Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis

NCT04798651 | Recruiting

• 1 other identifier: CHUBX 2020/71
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

  At inclusion (day 0)

Secondary Outcomes (11)

• Quantification of disease activity scores

  At inclusion (day 0)

• Quantification of disease activity scores

  At inclusion (day 0)

• Number of lesions

  At inclusion (day 0)

• Size of lesions

  At inclusion (day 0)

• Localisation of lesions

  At inclusion (day 0)

Study Arms (1)

patients with multiple sclerosis or clinically isolated syndrome

EXPERIMENTAL

subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome

Biological: blood sample; Biological: cerebro-spinal fluid

Interventions

blood sample BIOLOGICAL

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

patients with multiple sclerosis or clinically isolated syndrome

cerebro-spinal fluid BIOLOGICAL

1 ml of cerebro-spinal fluid

patients with multiple sclerosis or clinically isolated syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Bordeaux: collaborator
• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux - service de neurologie

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Autoimmune Diseases of the Nervous System

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Aurélie RUET, Prof

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Nathalie SCHMITT, PhD

  University of Bordeaux

  STUDY DIRECTOR

Central Study Contacts

Aurélie RUET, Prof

CONTACT

05 56 79 55 21; aurelie.ruet@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 15, 2021
• Study Start: September 30, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)