- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02857192
Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease (ACG et TREG)
Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease)
Giant cell arteritis (GCA) is the most frequent vascularitis after 50 years of age The investigators recently showed that GCA was accompanied by an elevation in Th1 and Th17 response [1]. Even though a quantitative deficit in regulatory TL (Treg) was shown, there are to date no data concerning their precise phenotypic and functional characteristics and notably their ability to inhibit Th1 and Th17 polarisation. The hypothesis of the investigator is that, in GCA, there is quantitative and above all functional deficit of Treg. Recently, progress has been made in the identification of Treg with new markers (CD39), which will make it possible to better identify and to study their specific functions. In this study the phenotypic and functional characteristics of Treg in GCA will be analysed. Better understanding of the role des Treg in GCA should lead to better-targeted treatments for patients with GCA, notably via the blockage of cytokines that inhibit the differentiation and/or function of Treg.
The study is classified interventional because a lot of blood samples are taken.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Dijon, France, 21079
- Centre Hospitalier Universitaire
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Patients
- Patients who have provided written consent
- Patients with national health insurance cover
- Age > 50 years
- Patients with a diagnosis of Horton's disease, before any treatment
Horton's disease is defined by the American College Rheumatology ACR criteria [2], as the association of 3 of the following 5 criteria:
- age at disease onset 50 years or older
- recent onset localized headache
- indurated temporal artery or diminished/abolition of temporal pulse
- erythrocyte sedimentation rate (ESR) greater than 50 mm during the first hour (or C Reactive protein (CRP)>20 mg/L)
- Positive temporal artery biopsy (TAB) showing vascularitis with infiltration by mononuclear cells or granulomatous inflammation with or without giant cells.
Control subjects
Control subjects will be healthy volunteers recruited among blood donors at Dijon University Hospital, voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and patients without infectious, inflammatory or auto-immune diseases or cancer (CRP<5mg/L) recruited in the investigating departments of Dijon Hospital. They will be matched for age and sex and must meet the following criteria:
- Age > 50 years
- Patients with national health insurance cover
- Signed written informed consent form
- Absence of an inflammatory syndrome (CRP<5 mg /L)
Exclusion Criteria:
- Adult under guardianship
- Persons without national health insurance cover
- Pregnant or breast-feeding women
- Patients treated with corticoids or immunosuppressants in the month preceding inclusion
- Patients treated with chemotherapy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: contrôle
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Expérimental: Horton
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Measurement by flow cytometry of the percentage of CD39+ Treg (CD4+CD25highFoxP3+CD39+) among total CD4 TL
Délai: through study completion an average of 30 months
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through study completion an average of 30 months
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Maladies vasculaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies de la peau
- Maladies du système immunitaire
- Maladies auto-immunes du système nerveux
- Maladies auto-immunes
- Maladies musculo-squelettiques
- Maladies rhumatismales
- Maladies du tissu conjonctif
- Maladies musculaires
- Vascularite
- Maladies de la peau, vasculaire
- Vascularite, système nerveux central
- Artérite
- Pseudopolyarthrite rhizomélique
- Artérite à cellules géantes
Autres numéros d'identification d'étude
- SAMSON APJ 2014
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Échantillons de sang
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Hillel Yaffe Medical CenterInconnue