DIGICODSuivi sur 6 ans de patients atteints d'arthrose de la main : facteurs cliniques, biologiques, génétiques et d'imagerie
Cette étude vise à identifier les facteurs cliniques, biologiques, génétiques et d'imagerie de base qui peuvent contribuer à l'aggravation de l'arthrose de la main après 6 ans de suivi, en utilisant divers outils d'évaluation tels que l'indice australien/canadien d'arthrose de la main (AUSCAN VA3.0) et d'autres.
GENETIC and radiographs
Autre étude
Résumé
Date de début de l'étude : 1 avril 2013
Date à laquelle le premier participant a commencé l'étude.Primary objective To investigate in hand OA patients predictive clinical, biological, genetic and imaging factors of clinical aggravation after 6 years of follow-up. Secondary objectives To investigate in hand OA patients predictive clinical, biological, genetic and imaging factors of clinical aggravation after 3 years of follow-up. To investigate in hand OA patients predictive clinical, biological, genetic and imaging factors of clinical aggravation between inclusion and 3 years of follow-up and between inclusion and the end of follow-up at 6 years. To determine the clinical, biological and radiographic factors predictive of the radiographic progression of OA between inclusion and 3 years but also between inclusion and 6 years To investigate whether clinical changes and radiographic structural changes are associated or correlated between inclusion and 3 years of follow-up or between inclusion and 6 years of follow-up To investigate whether clinical status and radiographic alterations are correlated at inclusion To determine whether hand OA is associated with other OA at other sites or with other hand diseases (carpal tunnel syndrome, tendinitis) To evaluate frequency of erosive hand OA among the whole hand OA cohort at inclusion, at 3 and 6 years of follow-up To identify clinical, biological, genetic and imaging factors associated with erosive hand OA (versus non erosive hand OA) at inclusion or during the follow up (3 and 6 years) To investigate predictive clinical, biological, genetic and imaging factors of clinical or radiographic aggravation after 3 or 6 years of follow-up in the erosive hand OA subgroup To perform a cross-sectional analysis of the correlation between clinical tools and erosive radiographic involvement at inclusion (in the population with erosive hand OA at inclusion) ; To evaluate the frequency of fibromyalgia at 3 years of follow-up and at the end of the follow-up at 6 years ; To evaluate the frequency of neuropathic pain at 3 years of follow-up and at the end of the follow-up at 6 years ; To evaluate the pressure pain threshold at 3 years of follow-up and at the end of the follow-up at 6 years. Methods : Prospective observational study The study will be proposed to all patients viewed at the out-patient clinic for hand OA which took place in Saint-Antoine Hospital in Rheumatology Department since 2004 (usually 12/week). The investigators plan to include 500 patients in the cohort (5/week). 7 visits (one per year) are planned: M0, M12, M24, M36, M48, M60 and M72. A clinical evaluation of hand OA will be performed at each visit. At visit M0, M36 and M72, hand radiographs and radiographs of other OA localisation (if symptomatic) will be performed. A blood sample will be taken at inclusion for biomarker studies and genetic investigations. A blood sample will be taken at M36 and M72 to build a prospective serum collection. Duration of the study: 8.5 years with 2.5 years of inclusion period Duration of the study for one patient: 6 years Recruitment at the Rheumatology Department of Saint-Antoine Hospital with a multicentric international steering committee
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.500 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 35 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Service de Rhumatologie - Hôpital Saint-Antoine
Paris, FranceOuvrir Service de Rhumatologie - Hôpital Saint-Antoine dans Google Maps