NCT05507723 Tight Control of Gouty Arthritis Compared to Usual Care
| NCT ID | NCT05507723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Gout |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2028-05-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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.