Tight-control treatment approach for gout compared with usual care
Effect of Tight Urate Control in Gouty Arthritis Compared to Usual Care (TICOGA), a Randomised Clinical Trial
NA · University of Edinburgh · NCT05507723
This trial will test whether teaching adults with gout to self-test their blood urate with a finger-prick and use a smartphone app to guide medication adjustments helps them reach urate targets and reduce flares compared with usual care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh (other) |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT05507723 on ClinicalTrials.gov |
What this trial studies
About 125 adults with gout will be randomized 1:1 to a treat-to-target arm or to usual care, with stratification by the need for flare prophylaxis. All participants get the GoutSMART app, but the treat-to-target group receives a full app plus a BeneCheck Plus finger-prick device and test strips to record home serum urate and follow app-guided dose escalation within predefined safety ceilings; usual care participants get a limited app and rely on GP-led treatment decisions. Individual maximum allopurinol doses and the need for colchicine prophylaxis are set based on baseline renal function and flare history. Participants are recruited through NHS Lothian rheumatology and gout services in Edinburgh.
Who should consider this trial
Good fit: Adults (≥18) with a confirmed ACR/EULAR diagnosis of gout, at least one flare in the past 12 months, serum urate >0.36 mmol/L, not on maximum urate-lowering therapy, and able to install the GoutSMART app on a smartphone are ideal candidates.
Not a fit: Patients with end-stage renal failure or transplant, those already on maximum tolerated urate-lowering therapy or with contraindicating drug interactions (e.g., azathioprine), or those unable to consent or use a smartphone are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could help patients reach target urate levels faster, reduce gout flares, and reduce the need for clinic-based dose adjustments.
How similar studies have performed: Previous treat-to-target and nurse-led urate-titration programs have improved urate control, but home finger-prick urate monitoring combined with smartphone app–guided self-titration is relatively novel and less extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Subject unable to provide consent * Patient on maximum urate lowering therapy or where therapy cannot be escalated further due to intolerance/adverse reaction to either allopurinol or febuxostat. * End stage renal failure/transplant * Current prescription of medication known to interact with xanthine oxidase inhibitors such as azathioprine or mercapto-purine.
Where this trial is running
Edinburgh
- NHS Lothian — Edinburgh, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Philip L Riches, FRCP, PhD — NHS Lothian
- Study coordinator: Philip L Riches, FRCP, PhD
- Email: philip.riches@nhs.scot
- Phone: +44 7944625313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gout, treat-to-target, gout