Multiple SclerosisMUST-BENCT04231253
MUltiple Sclerosis : T Cell / B Cell Exploration
An observational study of Multiple Sclerosis, run by Rennes University Hospital at 1 site in France.
Trial summary
This study, an ancillary to ABCD-SEP (NCT03744351), will be interested in more precisely characterizing circulating and infiltrating TH cells in Multiple Sclerosis whether at the transcriptomic level or at the functional level. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2019to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population concerned is the same as the one participating in the ABCD-SEP study. These patients gave their consent for the remaining biological samples to be used for ulterior research
Who may be able to join
- Regarding MS patients (remitting or progressive untreated):
- Adult (age greater than or equal to 18 years) of both sexes;
- MS fulfilling the criteria of McDonald 2017;
- Remittent or progressive form;
- No immunomodulatory or immunosuppressive therapy for at least 3 months;
- Free, informed and written consent signed by the patient.
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- Regarding Clinically Isolated Syndrome:
- Adult (age greater than or equal to 18 years) of both sexes;
- Clinically isolated syndrome suggestive of MS (at least two typical lesions in two different locations);
- Patient receiving a Lumbar Puncture (PL) for diagnostic purposes;
- No immunomodulatory or immunosuppressive therapy for at least 3 months;
- Free, informed and written consent signed by the patient.
- Regarding non-MS patients with neurological inflammatory disease:
- Adult (age greater than or equal to 18 years) of both sexes;
- Patient with non-MS neurological inflammatory disease (examples: meningitis, neurolupus, neurosarcoidosis...);
- Patients with PL for diagnostic or surveillance purposes;
- No immunomodulatory or immunosuppressive therapy for at least 3 months;
- Free, informed and written consent signed by the patient.
- Regarding healthy volunteers:
- Adult (age greater than or equal to 18 years) of both sexes;
- Free, informed and written consent signed by the volunteer.
Who cannot join
- Regarding all patients:
- Pregnancy;
- Breastfeeding;
- Treatment with corticotherapy in the last month;
- Patient not affiliated to health insurance;
- Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.
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- Regarding healthy volunteers:
- Pregnancy;
- Breastfeeding;
- Not affiliated to social security;
- Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: T Cell/B Cell Collaboration in Multiple Sclerosis: Exploring an Intimate Relationship
This study, an ancillary to ABCD-SEP (NCT03744351), will be interested in more precisely characterizing circulating and infiltrating TH cells in Multiple Sclerosis whether at the transcriptomic level or at the functional level.
Read the detailed description
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the Central Nervous System (CNS) affecting mostly young adults between 20 and 40 years of age. This disease is the leading cause of non-traumatic disability in young adults.
MS has long been considered a predominantly T-cell mediated disease. However, the remarkable efficacy of anti-CD20 monoclonal antibodies in this disease has demonstrated the major role of B-cell in the pathophysiology of this disease.
The B-cell have many functions: these cells are indeed able to secrete cytokines (pro and anti inflammatory), to present antigens to T lymphocytes, but also to differentiate into plasmocytic cells and thus to secrete immunoglobulins. Several studies have shown that B-cell in patients with MS secrete significantly more pro-inflammatory cytokines (GM-CSF, IL-6, TNFα). In addition, infiltrates and tertiary lymphoid structures have been found in the meninges of patients with MS, particularly in progressive forms of the disease. It seems clear to this day that these cells are strongly involved in the development of MS. Despite the many advances made recently in understanding the role of B-cell in the pathophysiology of MS, the precise involvement of plasma cells and their functions at different stages of the disease remains unclear.
Folluclar helper T cells (TFH) play a crucial role in lymphocyte B differentiation. These cells are located within the germinal centers in the secondary lymphoid organs, and their memory compartment also circulates in the blood. Several circulating TFH subpopulations have recently been defined, with different "helping" capacities.
This study, an ancillary to ABCD-SEP (NCT03744351), will be interested in more precisely characterizing circulating and infiltrating TH cells in Multiple Sclerosis whether at the transcriptomic level or at the functional level.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the transcriptome profile of infiltrating TFH cells from CIS patients to non-MS patients with neurological inflammatory diseases
Comparison of each gene expression of infiltrating TFH cells from CIS patients to those of non-MS patients with neurological inflammatory diseases by RNAsequencing
Measured: At inclusion
Secondary outcomes (3)
To compare the transcriptome profile of infiltrating TFH cells from CIS patients to healthy volunteers.
Comparison of each gene expression of infiltrating TFH cells from CIS patients to those of healthy volunteers (HV) by RNAsequencing
Measured: At inclusion
To compare the B cell differentiation helping abilities of TFH cells from MS patients to those of HV
Analysis of B cell phenotype after 7 days of in vitro coculture assays and comparison of the frequencies between MS patients and HV
Measured: At inclusion
To compare the migration abilities of TFH cells from MS patients to those of HV
Analysis of the rate, number and phenotype of migrating TFH cells after 12 to 24 hours using an in vitro model of Blood Brain Barrier in MS patients compared to HV
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start25 Feb 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure Michel, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231253
- Sponsor's protocol ID
- 35RC19_8871_MUST-BE
- Acronym
- MUST-BE
- Status last verified
- Dec 2021
- First submitted
- 13 Jan 2020
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T Cell/B Cell Collaboration in Multiple Sclerosis: Exploring an Intimate Relationship
- ClinicalTrials.gov ID
- NCT04231253
- Acronym / sponsor ID
- MUST-BE / 35RC19_8871_MUST-BE
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 18 Jan 2020 (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.
This study, an ancillary to ABCD-SEP (NCT03744351), will be interested in more precisely characterizing circulating and infiltrating TH cells in Multiple Sclerosis whether at the transcriptomic level or at the functional level.
Detailed description
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the Central Nervous System (CNS) affecting mostly young adults between 20 and 40 years of age. This disease is the leading cause of non-traumatic disability in young adults.
MS has long been considered a predominantly T-cell mediated disease. However, the remarkable efficacy of anti-CD20 monoclonal antibodies in this disease has demonstrated the major role of B-cell in the pathophysiology of this disease.
The B-cell have many functions: these cells are indeed able to secrete cytokines (pro and anti inflammatory), to present antigens to T lymphocytes, but also to differentiate into plasmocytic cells and thus to secrete immunoglobulins. Several studies have shown that B-cell in patients with MS secrete significantly more pro-inflammatory cytokines (GM-CSF, IL-6, TNFα). In addition, infiltrates and tertiary lymphoid structures have been found in the meninges of patients with MS, particularly in progressive forms of the disease. It seems clear to this day that these cells are strongly involved in the development of MS. Despite the many advances made recently in understanding the role of B-cell in the pathophysiology of MS, the precise involvement of plasma cells and their functions at different stages of the disease remains unclear.
Folluclar helper T cells (TFH) play a crucial role in lymphocyte B differentiation. These cells are located within the germinal centers in the secondary lymphoid organs, and their memory compartment also circulates in the blood. Several circulating TFH subpopulations have recently been defined, with different "helping" capacities.
This study, an ancillary to ABCD-SEP (NCT03744351), will be interested in more precisely characterizing circulating and infiltrating TH cells in Multiple Sclerosis whether at the transcriptomic level or at the functional level.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population concerned is the same as the one participating in the ABCD-SEP study. These patients gave their consent for the remaining biological samples to be used for ulterior research
Key inclusion criteria (21 listed)
- Adult (age greater than or equal to 18 years) of both sexes;
- MS fulfilling the criteria of McDonald 2017;
- Remittent or progressive form;
- No immunomodulatory or immunosuppressive therapy for at least 3 months;
- Free, informed and written consent signed by the patient.
Key exclusion criteria (11 listed)
- Pregnancy;
- Breastfeeding;
- Treatment with corticotherapy in the last month;
- Patient not affiliated to health insurance;
- Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare the transcriptome profile of infiltrating TFH cells from CIS patients to non-MS patients with neurological inflammatory diseases
Time frame: At inclusion
Comparison of each gene expression of infiltrating TFH cells from CIS patients to those of non-MS patients with neurological inflammatory diseases by RNAsequencing
3 secondary outcomes
To compare the transcriptome profile of infiltrating TFH cells from CIS patients to healthy volunteers.
Time frame: At inclusion
To compare the B cell differentiation helping abilities of TFH cells from MS patients to those of HV
Time frame: At inclusion
To compare the migration abilities of TFH cells from MS patients to those of HV
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
Related trials for Multiple Sclerosis
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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. This study is not recruiting at the moment.
Laure Michel principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Rennes University Hospital 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 21 inclusion and 11 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: finished, as of the sponsor's last update on 2 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the transcriptome profile of infiltrating TFH cells from CIS patients to non-MS patients with neurological inflammatory diseases (time frame: At inclusion). 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 2 Dec 2021.