None listed
Conditions
Brief summary
The current management of gout is far from optimal in both primary and also in specialised health care. Treatment with focus on the acute gout attack has too often led to a lack of emphasis on persistent long-term treatment, even though we know that the disease is curable. In this study we examine whether a treat-to-target approach, applying recent advances in disease management is feasible for clinical practice. Our hypothesis is that this will prevent new gout attacks, lower serum urate to target in most patients and thereby and also remove of urate deposits from joints and tendons. Assessments include a broad spectrum of clinical measures, questionnaires, advanced imaging methods and cardiovascular assessment. The study will greatly benefit patients and improve gout care.
Interventions
Patients are treated in the rheumatology outpatient department as clinically required. The treatment objective is to reduce serum urate to a treatment target below 360 micromol/L, and 300 micromol/L in case of tophi. The treatment approach is in line with the EULAR treatment recommendations for gout. The first drug of choice is allopurinol 100 mg tablets once daylig. The dose will be increased monthly by 100 mg until maximum 900 mg daily is reached or the treatment target is met. In case insufficient effect (i.e. not reaching the treatment target) or adverse events, other approved drugs can be used such as probenecid 500 mg tablets (maximum 1000 mg daily) to increase excretion of uric acid or febuxostat tablets (40 mg to maximum 120 mg daily) as an alternative xanthinoxidase inhibitor. If patients already use urate lowering therapy when included into the study, medication will be increased if necessary to reach the treatment target. All patients who start urate lowering therapy during the study period, will be given flare prophylaxis with anti-inflammatory medication (an NSAID or colchicine orally) for 6 months at the discretion of the treating physician. Adherence to treatment and adverse events are monitored during the frequent visits by physician or nurse (initially every month), inquiring if the patient has taken the prescribed drugs and has experienced adverse events. Serum urate, as a measure of adherence is also checked frequently and initially every month. If serum urate at the baseline visit is only slightly increased (360-420µmol/l), diet and life-style advice during the first month can be given alone, to see if these measure are sufficient to reduce serum urate to target until the next study visit. Study visits are initially monthly and monitor adherence to therapy, laboratory tests for serum urate, liver and kidney function as well as adverse events, When the treatment target of 360µmol/l is reached, existing medication is maintained at the present dose and fixed visits are schedules at 3, 6, 12 and 24 months.
Sponsors
Study design
Eligibility
Inclusion criteria
a) Classification of gout with urate crystals demonstrated in joint fluid or tophus b) Acute gout attack during the last month c) Increased serum urate level
Exclusion criteria
a.) Severe co-morbidity, including heart failure (NYHA III-IV) or kidney failure (eGFR<45 ml/min, CKD stage 3B) b.) Inability to comply with the protocol requirements