Multiple SclerosisT4MSNCT04798651
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
A study testing blood sample and cerebro-spinal fluid in people with Multiple Sclerosis and Clinically Isolated Syndrome, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Clinically Isolated Syndrome
- What is being tested?
- blood sample and cerebro-spinal fluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2021to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux - service de neurologie
Bordeaux
Aurélie RUET, Prof, aurelie.ruet@chu-bordeaux.fr
Aurélie RUET, Prof
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome
- Being tested
- blood sample, cerebro-spinal fluid
- Keywords
- Autoimmune Diseases of the Nervous System, Multiple sclerosis, clinically isolated syndrome, lymphoid cells, CD4 T cells, B cells
- Medical subject headings
- Multiple Sclerosis, Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
cerebro-spinal fluidBiological
1 ml of cerebro-spinal fluid
| Study group | Role | What they receive |
|---|---|---|
| patients with multiple sclerosis or clinically isolated syndrome | Experimental | subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome Receives: Biological: blood sample; Biological: cerebro-spinal fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients.
Measured: At inclusion (day 0)
Secondary outcomes (11)
Quantification of disease activity scores
Expanded Disability Status Scale (EDSS)
Measured: At inclusion (day 0)
Quantification of disease activity scores
ambulation test
Measured: At inclusion (day 0)
Number of lesions
evaluated by MRI
Measured: At inclusion (day 0)
Size of lesions
evaluated by MRI
Measured: At inclusion (day 0)
Localisation of lesions
evaluated by MRI
Measured: At inclusion (day 0)
Types of lesions
evaluated by MRI
Measured: At inclusion (day 0)
duration of the disease
Measured: At inclusion (day 0)
age at onset and progression
Measured: At inclusion (day 0)
number of relapses
Measured: At inclusion (day 0)
date of relapses
Measured: At inclusion (day 0)
Treatment
Measured: At inclusion (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start30 Sep 2021
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bordeaux
- Responsible party
- Sponsor
- Investigators
- Aurélie RUET, Prof, Principal investigator, University Hospital, BordeauxNathalie SCHMITT, PhD, Study director, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798651
- Sponsor's protocol ID
- CHUBX 2020/71
- Acronym
- T4MS
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04798651
- Acronym / sponsor ID
- T4MS / CHUBX 2020/71
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- University of Bordeaux
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with multiple sclerosis or clinically isolated syndrome | Experimental | Biological: blood sample, Biological: cerebro-spinal fluidsubjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation | Biological | patients with multiple sclerosis or clinically isolated syndrome |
| cerebro-spinal fluid1 ml of cerebro-spinal fluid | Biological | patients with multiple sclerosis or clinically isolated syndrome |
Primary outcome
Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients.
Time frame: At inclusion (day 0)
11 secondary outcomes
Quantification of disease activity scores
Time frame: At inclusion (day 0)
Quantification of disease activity scores
Time frame: At inclusion (day 0)
Number of lesions
Time frame: At inclusion (day 0)
Size of lesions
Time frame: At inclusion (day 0)
Localisation of lesions
Time frame: At inclusion (day 0)
Types of lesions
Time frame: At inclusion (day 0)
duration of the disease
Time frame: At inclusion (day 0)
age at onset and progression
Time frame: At inclusion (day 0)
number of relapses
Time frame: At inclusion (day 0)
date of relapses
Time frame: At inclusion (day 0)
Treatment
Time frame: At inclusion (day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aurélie RUET, Prof principal investigator
University Hospital, Bordeaux
Nathalie SCHMITT, PhD study director
University of Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample and cerebro-spinal fluid in people with Multiple Sclerosis and Clinically Isolated Syndrome, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélie RUET, Prof (05 56 79 55 21 ext. +33, aurelie.ruet@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients. (time frame: At inclusion (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.