Essais cliniques sur Sclérose en plaques - Registre des essais cliniques

Aperçu de l'étude

Statut

Complété

Les conditions

Sclérose en plaques

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

90

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

France
- - Rennes, France, 35033
    - Rennes University Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

Inclusion Criteria:

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.

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.

Exclusion Criteria:

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.

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
To compare the transcriptome profile of infiltrating TFH cells from CIS patients to non-MS patients with neurological inflammatory diseases Délai: 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	At inclusion

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
To compare the transcriptome profile of infiltrating TFH cells from CIS patients to healthy volunteers. Délai: At inclusion	Comparison of each gene expression of infiltrating TFH cells from CIS patients to those of healthy volunteers (HV) by RNAsequencing	At inclusion
To compare the B cell differentiation helping abilities of TFH cells from MS patients to those of HV Délai: At inclusion	Analysis of B cell phenotype after 7 days of in vitro coculture assays and comparison of the frequencies between MS patients and HV	At inclusion
To compare the migration abilities of TFH cells from MS patients to those of HV Délai: At inclusion	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	At inclusion

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Rennes University Hospital

Les enquêteurs

Chercheur principal: Laure Michel, Rennes University Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 février 2019

Achèvement primaire (Réel)

31 octobre 2021

Achèvement de l'étude (Réel)

31 octobre 2021

Dates d'inscription aux études

Première soumission

13 janvier 2020

Première soumission répondant aux critères de contrôle qualité