Effect of Tight Urate Control in Gouty Arthritis Compared to Usual Care (TICOGA), a Randomised Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Gout is caused by a reaction to urate crystals that results in attacks of severe joint pain. Medicines that lower urate levels can prevent gout flares, however it takes time for this benefit to be felt, and paradoxically starting treatment with large doses of urate lowering treatment risks provoking attacks of gout. Medical guidelines disagree on the best way to overcome these challenges with many recommending medicine dose adjustment based on regular urate testing but a general practice guideline suggesting more simply increasing the medicine dose in those patients that continue to suffer flares. In reality most patients are not treated at all, and many of those that are treated never receive an effective dose of treatment. We have developed a supported self-management approach to gout in which patients monitor their own urate levels using a finger prick test, and then receive advice on adjusting their treatment dose to achieve target urate levels through a smartphone app (Gout SMART). A trial of this approach has shown that it results in much better control of urate levels after 6 months than usual care, and suggests that it also leads to fewer flares. We would now like to confirm that this approach is effective in reducing flares of gout over 2 years by randomising patients to either treatment-to-target urate using our self-monitoring approach, or to usual care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Provision of informed consent.

• Age ≥18 years.

• Patient has sustained at least one flare of gout in the previous 12 months.

• Confirmed clinical diagnosis of gout as per ACR/EULAR criteria

• Serum urate \>0.36mm/L.

• Patient has a smart phone and is able to install GoutSMART application.

Locations
Other Locations
United Kingdom
NHS Lothian
RECRUITING
Edinburgh
Contact Information
Primary
Philip L Riches, FRCP, PhD
philip.riches@nhs.scot
+44 7944625313
Backup
Jo-Anne Robertson
resgov@accord.scot
0131 242 3326
Time Frame
Start Date: 2025-06-12
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Treat-to-target
All participants will have the GoutSMART application installed on their phones, and be offered a management plan including the use of flare prophylaxis and maximum advised dose of allopurinol based on renal function. All Participants in the treat-to-target group will be provided with a BeneCheck hand-held device and taught to perform urate finger prick self-testing. Participants will be prompted to submit urate readings by the GoutSMART app and if urate levels remain above target their allopurinol will be increased incrementally up to the pre-specified maximum dose of allopurinol.
Active_comparator: Usual care
All participants will have the GoutSMART application installed on their phones, and be offered a management plan including the use of flare prophylaxis and maximum advised dose of allopurinol based on renal function to achieve urate target. Participants in the usual care arm of the study will have their treatment reviewed and escalated by their GPs in line with usual practice.
Related Therapeutic Areas
Sponsors
Leads: University of Edinburgh

This content was sourced from clinicaltrials.gov