Project overview
Gout affects 1 in 40 adults in the UK. It is caused by high urate level which deposits as urate crystals inside the joints. When shed into the joint cavity, they cause gout attacks which manifests as severe joint pain, swelling, inability to use the joint and lasts for 1-2 weeks. Over time, the attacks become frequent and joint damage may occur. Medicines that lower urate level and dissolve these crystals are cheap, safe, and have been available for decades. However, whether their use at doses high enough to dissolve urate crystals prevents gout attacks is unknown. There is absence of direct randomised controlled trial data that such goal driven urate lowering treatment (ULT), with target serum urate <360 μmol/L prevents gout attacks in a cost-effective manner compared to treating when symptoms worsen. This lack of evidence results in poor gout management and culminated in discordant recommendations from gout treatment guidelines.
The objectives of this study are to evaluate the effects of allopurinol-based treat-to-target ULT on the number of gout attacks (primary outcome), gout flare severity, serum urate, quality of life, renal function and adverse events. We will also examine the cost-effectiveness, acceptability and adherence with such treatment.
Additionally, we will assess the consent rate, attrition, quality of outcome data, delivery of treat-to-target ULT, and preliminary estimate of efficacy of the intervention in a 1-year internal pilot.
Methods:
Study design: Multi-centre pragmatic RCT with internal pilot and long term follow-up.
Setting: Primary care
Study duration: 80 months
Participants: People with recurrent gout attacks(at least 1 attack in previous 12 months), older than 18 years.
Study groups:
Group A - allopurinol-based treat-to-target ULT
Group B - usual GP care
Intervention delivery: general practice nurses
Randomisation: 1:1 individual randomisation stratified by region and prior intolerance to Colchicine.
Study participation: Each participant in the study for 4 years, 2 years each in the RCT and long-term extension respectively.
Contact: sch-tr.t2tgout@nhs.net
