About the Trial
The T2T study is a multi-centre pragmatic RCT with an internal pilot and long term follow up.
Key Trial Information
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 an absence of direct randomised controlled trial data that such goal driven urate lowering treatment (ULT), with target serum urate <360μmol/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.
Recruitment target: 466 patients with recurrent gout attacks.
Approximate number of sites required: 60 GP Practices.
Study population: Patients aged 18 years or over, who are registered at a participating GP practice.
Planned recruitment period: Internal pilot will be 4 months and the main trial will be 7 months.
Planned start date: Closed to recruitment.
Follow up: 4 years