Tophaceous Gout Clinical Trial
Official title:
Evolution of Tophus and Erosions of Hands and Feet With Urate-lowering Therapy: Prospective Study Using Dual-Energy Computed Tomography
The main objective is to evaluate the decrease in crystalline volume of the target tophus using Dual-Energy Computed Tomography (DECT), after 6 months +/- 1 month of urate-lowering therapy with target uricemia. Study hypothesis - The dynamics of tophus resolution with urate-lowering therapy is poorly understood. - It is variable according to the location of the tophus, peri articular / intratendinous, but also probably at the feet / hands, the initial overall volume of the tophus, the initial crystal charge of the tophus. Knowledge of prognostic factors for tophus resolution will help determine the best target for treatment follow-up for each patient. - Erosions are the consequence of tophus. Tophus resolution could be associated with repair of erosions and stabilization of joint destruction.
Study design The research is a non-randomized prospective bi-centric study in adult patients with tophaceous gout. It aims at studying tophus resolution (main objective), and prognostic factors for tophus resolution (secondary objective), and bone erosions, with Dual-Energy Computed Tomography (DECT) (secondary objective). Study population - Adult patients with a tophaceous gout but no urate-lowering treatment or treatment but target not reached (target = uricemia < 360µmol/L). - Recruitment of patients during a visit or hospitalization in rheumatology at Lariboisière Hospital. Calculated size of study population: 50 patients No control group Inclusion criteria - Age greater than or equal to 18 years - Patient with a tophaceous gout - Without urate-lowering treatment or with treatment but uricemia not at target - Having given its free and informed consent to participate in this study - Affiliated with a social security system Non-Inclusion criteria - Pregnant or breastfeeding woman - Participation in another intervention research or period of exclusion due to a previous research. - Impossibility to position oneself in ventral position (position for hands/wrists DECT acquisition). Acts or product added for the research study Dual-Energy Computed Tomography examination at 6 and 12 months +/- 1 month of medical treatment with uricemia < 360µmol/L (baseline DECT is in the domain of usual care). For each patient, 3 visits (usual care): - M0: Inclusion visit - M6 + /- 1 month: visit, usual care, + DECT for research purpose - M12 + /- 1 month: visit, usual care, + DECT for research purpose Research duration: - Inclusion period: 24 months - Duration of participation (treatment + follow-up): 12 months + /- 1 month - Total duration: 37 months ;
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