FEBUXOSTAT for Gout

Inclusion criteria

• {"criterion_text":"- •\tAge ≥ 18 years\n- •\tGout, defined according to the 2015 ACR/EULAR classification criteria\n- •\tNo flares for at least 2 years\n- •\tNo tophi\n- •\tCurrently receiving allopurinol or febuxostat taken for at least 2 years and SUA levels ≤ 60 mg/l\n- •\tNo urate deposit on ultrasound (score 0/24) at inclusion visit at both MTPs 1 and knees\n- •\tAbility to provide informed consent\n- •\tHealth Insurance."}

Exclusion criteria

• {"criterion_text":"- •\tUnstable systemic medical condition (e.g., New York Heart Association stage IV heart failure, recent myocardial infarction, advanced cancer)\n- •\tHistory of allergy to allopurinol or febuxostat or one of the excipients •\tAssociation with\n- •\tAssociation with azathioprine, mercaptopurine (cytostatics-antimetabolites)\n- •\tContraindications to experimental medicinal products or auxiliary medicinal products\n- •\tCKD stage 4 (eGFR less than 30 ml/mn/1.73 m2)\n- •\tOngoing treatment with uricosurics (benzbromarone and probenecid) or uricase\n- •\tPatient on SMA (state medical aid-AME)\n- •\tParticipation in other clinical trial on medicinal product for human use\n- •\tWomen of childbearing age."}

Primary endpoints

• {"endpoint_text":"- the proportion of patients experiencing one or more flares at two years (M24) according to the Gaffo’s criteria.","definition_or_measurement_approach":"Proportion of patients with one or more gout flares at 24 months (M24) assessed according to Gaffo's criteria."}

Secondary endpoints

• {"endpoint_text":"- •\tThe proportion of patients experiencing one or more flares at M6, M12, M18, M30 and M36 according to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)\n- •\tMean flare rates at M6, M12, M18, M24, M30, M36 according to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)\n- •\tUS features of gout at both MPT1s (double contour sign, tophi, aggregates) and both knees (double contour sign) at M6, M12, M18, M24, M30, M36 in the withdrawal arm and at M24 in the maintenance arm.\n- •\tUrate levels at M6, M12, M18, M24, M30, M36\n- •\tChange from baseline to M6, M12, M18, M24, M30 and M36 in Outcome Measures in Rheumatology (OMERACT) core outcome domains for long-term gout studies: Pain (VAS 0–100 mm), patient’s global assessment of disease activity (VAS 0–100mm); Health-related quality of life using the EuroQol 5-domain-3L (EQ-5D-3L) questionnaire; Activity limitation using the Health Assessment Questionnaire II\n- •\tIncidence of Major CardioVascular events (nonfatal stroke, nonfatal myocardial infarction, cardiovascular death) at M6, M12, M18, M24, M30, M36\n- •\tRenal function (eGFR) at M6, M12, M18, M24, M30, M36\n- •\tIncidence of comorbidities at M6, M12,M18, M24,M30 and M36\n- •\tOverall Survival at M12, M24 and M36\n- •\tConsumption of colchicine, NSAIDs, steroids using a patient self-reported notebook at M6, M12, M18, M24, M30, M36\n- •\tAdverse events and serious adverse events at M6, M12, M18, M24, M30, M36 according to the CTCAE V5.0 classification\n- •\tAdherence to ULT by the questionnaire MARS at M6, M12, M18, M24, M30 and M36\n- •\tIncremental Cost effectiveness ratios estimating cost per QALY gained\n- •\tIncremental Cost effectiveness ratios estimating cost per flare avoided.\n- Objective of any potential ancillary study: Blood samples for translational researches will be taken only from patients recruited at the Lariboisière centre at D0, M6, M12 and M24. The aim is to study the effects of the increase in urate levels on the innate immune system, the inflammatory pathways, particularly those involving monocytes, the proteome, the metabolome, the lipidome, the transcriptome and the epigenetic.\n- •\tAgreement between the local and central reading of ultrasound features through the study period (M0 to M36): kappa value for the DC sign, tophi and aggregates at MTP1 and knees.","definition_or_measurement_approach":"Endpoints measured at scheduled visits (M0/M6/M12/M18/M24/M30/M36) using specified instruments: Gaffo's criteria and GAIS for flares; ultrasound features at specified joints (DC sign, tophi, aggregates); serum urate (SUA) at scheduled visits; OMERACT core domains (pain VAS, patient global, EQ-5D-3L, HAQ-II) for patient-reported outcomes; CTCAE V5.0 for adverse events; eGFR for renal function; MARS questionnaire for adherence; consumption recorded in patient notebook; cost-effectiveness estimated as incremental cost per QALY and per flare avoided; ancillary translational blood sampling at Lariboisière at D0, M6, M12, M24; agreement between local and central US readings assessed by kappa statistics."}

France

Earliest CTIS Part Ii Submission Date

03-02-2025

Latest Decision Or Authorization Date

08-04-2026

Processing Time Days

429

Number Of Sites

23

Number Of Participants

450

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France