Allopurinol contre Febuxostat dans le traitement de la goutte : une approche de type traiter-pour-cible
This study aims to compare the effectiveness of Allopurinol and Febuxostat in treating gout by measuring the percentage of participants who experience at least one gout flare during the treatment phase, based on self-reported symptoms and medication usage.
allopurinol capsule, 100-800 mg by mouth once daily
+ Placebo, vehicle control (febuxostat-shaped)
+ febuxostat tablet 40-120 mg by mouth once daily
Arthropathies à cristaux+21
+ Maladies génito-urinaires
+ Arthrite
Étude thérapeutique
Résumé
Date de début de l'étude : 6 mars 2017
Date à laquelle le premier participant a commencé l'étude.Gout, a common form of arthritis, is a condition that causes inflammation in the joints and is particularly prevalent in older men and those with chronic kidney disease (CKD). Despite the availability of effective treatments, gout remains poorly managed, especially in patients with CKD. This study focuses on comparing the effectiveness of two widely used treatments for gout, allopurinol and febuxostat, which have never been compared at appropriate doses. The goal is to determine if allopurinol is as effective as febuxostat in managing gout, which could potentially improve treatment strategies and patient outcomes, particularly for those with CKD. In this study, 950 participants with gout, including those with stage 3 CKD, will be enrolled from various Veteran Affairs and Rheumatology and Arthritis Investigational Network sites. Over a period of 72 weeks, participants will receive either allopurinol or febuxostat, with doses adjusted to achieve specific targets. The study is divided into three phases: a 24-week dose titration phase, a 24-week maintenance and optimization phase, and a 24-week steady state flare observation phase. The primary outcome measured will be the proportion of participants who experience at least one gout flare during the third phase. A gout flare is defined by certain self-reported criteria such as joint warmth, swelling, pain, and self-identified flare, or by the use of medications to treat a flare.
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.950 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
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 18 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.Conditions
Pathologie
Critères
Inclusion Criteria: * Age 18 years * History of gout - crystal proven or historical as defined by ACR criteria listed above * Serum urate level \> 6.8 mg/dl Exclusion Criteria: * Stage 4 or 5 Chronic Kidney Disease (CKD) - defined as eGFR \< 30 ml/min/1.73 m2 * Women less than 50 years of age * Patients with a history of prior solid organ / hematopoietic transplantation * Previous allergy or intolerance to allopurinol or febuxostat * Patients who are not candidates for any of the recommended prophylactic medications (colchicine, naprosyn or glucocorticoids) * Patients who in the opinion of the investigator have a high genetic risk for allopurinol hypersensitivity syndrome (AHS\*) unless they have been found to be negative for HLA B5801. * Previous history of failure to reach target uric acid levels despite therapy with allopurinol at dose \> 300 mg/day * Prior febuxostat use * Patients with malignancies that are currently active with exception of non-melanoma skin cancer * Patients with serum uric acid levels \>15 mg/dl * Patients with myelodysplasia and hemoglobin of \< 8.5 mg/dL * Patients with chronic liver disease with more than one of the following: * INR \> 1.7, not on Warfarin therapy * Bilirubin 2 mg/dL * Serum albumin \< 3.5 mg/dL * Ascites * Encephalopathy * Current use of azathioprine, mercaptopurine, didanosine, cyclophosphamide, probenecid, lesinurad or pegloticase * Enrollment in another randomized interventional clinical trial * Any severe medical condition that, in the enrolleer's opinion, is likely to compromise the participant's ability to complete the trial
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Comparateur actifGroupe II
Comparateur actifObjectifs de l'étude
Objectifs principaux
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 23 sites
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, United StatesOuvrir VA Loma Linda Healthcare System, Loma Linda, CA dans Google MapsVA San Diego Healthcare System, San Diego, CA
San Diego, United StatesSan Francisco VA Medical Center, San Francisco, CA
San Francisco, United StatesMiami VA Healthcare System, Miami, FL
Miami, United States