Ensaio clínico em Esclerose múltipla - Registro de Ensaios Clínicos

Visão geral do estudo

Status

Concluído

Condições

Esclerose múltipla

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

90

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

França
- - Rennes, França, 35033
    - Rennes University Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
To compare the transcriptome profile of infiltrating TFH cells from CIS patients to non-MS patients with neurological inflammatory diseases Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
To compare the transcriptome profile of infiltrating TFH cells from CIS patients to healthy volunteers. Prazo: 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 Prazo: 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 Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Rennes University Hospital

Investigadores

Investigador principal: Laure Michel, Rennes University Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

25 de fevereiro de 2019

Conclusão Primária (Real)

31 de outubro de 2021

Conclusão do estudo (Real)

31 de outubro de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

13 de janeiro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ