- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03974997
TWEAK, a New Biomarker for Predicting Inflammatory Relapses in Multiple Sclerosis (TWEAK)
Indutor fraco de apoptose relacionado ao TNF (TWEAK), um novo biomarcador que prevê o impulso inflamatório na esclerose múltipla
A significant variation in the serum concentration of the circulating cytokine TWEAK is associated with the onset of an inflammatory attack of MS. Study the concentration variations of the serum soluble form of cytokine TWEAK during the first year of MS and to analyze their correlation with the occurrence of an inflammatory disease outbreak.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Multiple sclerosis (MS) is the most common chronic autoimmune demyelinating and neurodegenerative disease of the central nervous system (CNS) of disabling neurological diseases in young adults in France. Patients with MS can present a wide range of symptoms spread over time and space such as motor, sensory, visual or vesico-sphincter deficits. One of the current challenges in treating patients with symptoms suggestive of MS is to assess the risk of an inflammatory flare in order to avoid or limit the installation of an irreversible neurological handicap. At present, the inflammatory activity of the disease is evaluable only by cerebral imaging (MRI). However, these examinations can not be carried out as often as necessary because of their accessibility, cost, duration and the potential deleterious effects of gadolinium accumulation. This is why a blood biomarker able to report early on the inflammatory activity of the disease would be of great help during the monitoring and treatment of patients. TWEAK (TNF-related weak inducer of apoptosis or TNFSF12) is a pro-inflammatory cytokine member of the TNF family. This cytokine is overexpressed in tissues with chronic inflammatory diseases such as MS. It is produced by monocytes / macrophages and microglial cells and can exist in soluble or membrane form the investigators of the clinical department were the first to describe the pro-inflammatory role of TWEAK in MS. Indeed, the investigators have demonstrated in an animal model of MS that the inhibition of TWEAK makes it possible to reduce the severity of the disease. Their recent work (manuscript submitted for publication) has also shown results from a series of 28 patients with MS suggesting that the serum TWEAK assay may be an early marker of thrust occurrence. The investigators propose to study the concentration variations of the serum soluble form of cytokine TWEAK during the first year of MS and to analyze their correlation with the occurrence of an inflammatory disease outbreak. The investigators will perform a prospective study in which 50 patients with MS in the isolated clinical syndrome stage will be included over a 12-month period. Mental Cerebral MRIs will be performed for each patient at baseline (T0), month 6, and month 12. Serum dosages of TWEAK will be performed each month for each patient for one year. Patients will also be treated with soluble TNF, the leader in the TNF family of ligands, anti-TWEAK antibodies (which may interfere with the activity and dosage of TWEAK) as well as C-reactive Protein C ( search for intercurrent infectious episode). These dosages will be correlated with the clinical evolution (appearance or not of an inflammatory flare) as well as the data of the imagery (number of lesions raised or not by the gadolinium).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Sophie DESPLAT-JEGO
- Número de telefone: + 33 4 91 38 39 07
- E-mail: sophie.jego-desplat@ap-hm.fr
Locais de estudo
-
-
-
Marseille, França, 13354
- Recrutamento
- Assistance Publique Hopitaux de Marseille
-
Contato:
- Sophie DESPLAT-JEGO, IP
- Número de telefone: +33 04 91 38 39 07
- E-mail: promotion.interne@ap-hm.fr
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- a first episode of inflammation and demyelination of the central nervous system affecting the optic nerve, the spinal cord, one cerebral hemisphere, or the brainstem; or confirmed multiple sclerosis
- no differential diagnosis at enrollment based on clinical examination and laboratory tests
- compliance with the revised 2017 Mac Donald diagnostic criteria
Exclusion Criteria:
- age <18 years old
- person in an emergency situation
- adult who is subject to a legal protection measure (an adult under guardianship, conservatorship, or judicial protection), or who is unable to give consent
- not Enrolled in a Social Security Program
- pregnant or breastfeeding woman
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: serum concentration changes in cytokine TWEAK
We will perform a prospective study in which 50 patients with multiple sclerosis in the isolated clinical syndrome stage will be included over a 12-month period. Mental Cerebral MRIs will be performed for each patient at baseline (T0), month 6, and month 12. Serum dosages of TWEAK will be performed each month for each patient for one year. Patients will also be treated with soluble TNF, the leader in the TNF family of ligands, anti-TWEAK antibodies (which may interfere with the activity and dosage of TWEAK) as well as C-reactive Protein C ( search for intercurrent infectious episode). These dosages will be correlated with the clinical evolution (appearance or not of an inflammatory flare) as well as the data of the imagery (number of lesions raised or not by the gadolinium). |
Blood samples (20 ml of blood on dry tube) by venipuncture at the bend of the elbow will be made at T0, then monthly for a period of 1 year . The sera will be isolated by centrifugation and then frozen at -80 degrees Assays of the soluble form of TWEAK and TNF will be performed by ELISA blot technique developed by the team. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The serum concentration of soluble TWEAK
Prazo: 1 year
|
We will then compare the soluble TWEAK concentrations observed in patients with anti-TWEAK antibodies and in patients without anti-TWEAK antibodies. We will study the correlation between the concentrations of soluble TWEAK and those of soluble TNF. |
1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The titers of anti-TWEAK antibodies
Prazo: 1 year
|
Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample |
1 year
|
|
Functional properties of anti-TWEAK antibodies
Prazo: 1 year
|
Positive or negative test Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample |
1 year
|
|
Soluble TWEAK concentrations
Prazo: 1 year
|
Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample |
1 year
|
|
Serum concentrations of soluble TNF
Prazo: 1 year
|
Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample |
1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Jean-Olivier ARNAUD, Assistance Publique des Hôpitaux de Marseille
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RCAPHM19_0158
- 2020-A00770-39 (Outro identificador: IDRCB)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .