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.

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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:

Emily Hughes
Stephanie Butler-Walley

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.