Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis (T4MS)
Primary Purpose
Multiple Sclerosis, Clinically Isolated Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
cerebro-spinal fluid
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis focused on measuring Autoimmune Diseases of the Nervous System, Multiple sclerosis, clinically isolated syndrome, lymphoid cells, CD4 T cells, B cells
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)
Sites / Locations
- CHU de Bordeaux - service de neurologieRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients with multiple sclerosis or clinically isolated syndrome
Arm Description
subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome
Outcomes
Primary Outcome Measures
Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients.
Secondary Outcome Measures
Quantification of disease activity scores
Expanded Disability Status Scale (EDSS)
Quantification of disease activity scores
ambulation test
Number of lesions
evaluated by MRI
Size of lesions
evaluated by MRI
Localisation of lesions
evaluated by MRI
Types of lesions
evaluated by MRI
duration of the disease
age at onset and progression
number of relapses
date of relapses
Treatment
Full Information
NCT ID
NCT04798651
First Posted
March 11, 2021
Last Updated
February 2, 2022
Sponsor
University Hospital, Bordeaux
Collaborators
University of Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04798651
Brief Title
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
Acronym
T4MS
Official Title
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
University of Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Clinically Isolated Syndrome
Keywords
Autoimmune Diseases of the Nervous System, Multiple sclerosis, clinically isolated syndrome, lymphoid cells, CD4 T cells, B cells
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with multiple sclerosis or clinically isolated syndrome
Arm Type
Experimental
Arm Description
subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
Intervention Type
Biological
Intervention Name(s)
cerebro-spinal fluid
Intervention Description
1 ml of cerebro-spinal fluid
Primary Outcome Measure Information:
Title
Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients.
Time Frame
At inclusion (day 0)
Secondary Outcome Measure Information:
Title
Quantification of disease activity scores
Description
Expanded Disability Status Scale (EDSS)
Time Frame
At inclusion (day 0)
Title
Quantification of disease activity scores
Description
ambulation test
Time Frame
At inclusion (day 0)
Title
Number of lesions
Description
evaluated by MRI
Time Frame
At inclusion (day 0)
Title
Size of lesions
Description
evaluated by MRI
Time Frame
At inclusion (day 0)
Title
Localisation of lesions
Description
evaluated by MRI
Time Frame
At inclusion (day 0)
Title
Types of lesions
Description
evaluated by MRI
Time Frame
At inclusion (day 0)
Title
duration of the disease
Time Frame
At inclusion (day 0)
Title
age at onset and progression
Time Frame
At inclusion (day 0)
Title
number of relapses
Time Frame
At inclusion (day 0)
Title
date of relapses
Time Frame
At inclusion (day 0)
Title
Treatment
Time Frame
At inclusion (day 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie RUET, Prof
Phone
05 56 79 55 21
Ext
+33
Email
aurelie.ruet@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilde DELOIRE, PhD
Email
mathilde.deloire@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie RUET, Prof
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nathalie SCHMITT, PhD
Organizational Affiliation
University of Bordeaux
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Bordeaux - service de neurologie
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie RUET, Prof
Email
aurelie.ruet@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Mathilde DELOIRE, PhD
Email
mathilde.deloire@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Aurélie RUET, Prof
First Name & Middle Initial & Last Name & Degree
Jean-Christophe OUALLET, MD
First Name & Middle Initial & Last Name & Degree
Cécile DULAU, MD
First Name & Middle Initial & Last Name & Degree
Pauline BUISSONNIERE, MD
First Name & Middle Initial & Last Name & Degree
Louis NADAL, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
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