Treat to target in Gout
What is the clinical and cost-effectiveness of using a goal-directed allopurinol-based treat-to-target protocol in people with recurrent gout flares? Protocol for a randomised controlled trial and internal pilot study.
Summary
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 to such treatment.
| Chief Investigator: |
Professor Abhishek Abhishek (University of Nottingham) |
| Associate Investigator: | Professor Edward Roddy |
| Trial Manager: |
Steff Garvin |
| Sponsor / reference number: | Keele University |
| Funder / reference number: | NIHR HTA / 17/82/02 |
| Registration reference number: | ISRCTN12059648 |
| Start date: | 1 Jan 2019 |
| End date: | 1 Aug 2025 |
Study design
Parallel-arm multicentre randomised controlled trial with one-year internal pilot and a two-year long-term extension phase.
Aim and objectives
Primary objectives:
To evaluate the long-term effect of continued allopurinol-based treat-to-target ULT versus usual GP care on number of gout flares in years 3-4.
Secondary objectives:
To evaluate the long-term effect of continued allopurinol-based treat-to-target ULT versus usual GP care on healthcare utilisation for gout in years 3-4, incidence of comorbidities, and mortality.