Clinical trial NCT05507723: Tight Control of Gouty Arthritis Compared to Usual Care
Official title: Effect of Tight Urate Control in Gouty Arthritis Compared to Usual Care (TICOGA), a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gout
Keywords: treat-to-target
gout
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: A total of approximately 120 participants will be recruited. We anticipate that most participants will be identified following referral to rheumatology outpatient or on-call services in National Health Service (NHS) Lothian, or through NHS Lothian's gout liaison service. Additional patients may indicate their willingness to participate directly in response to study advertisements.

Based on baseline renal function and flare frequency, an individual treatment plan will be drawn up for all participants which will set a ceiling on the maximum dose of allopurinol to be used within the trial and determine the need for flare prophylaxis with colchicine. Participants will be randomized to the intervention group in a 1:1 ratio, with stratification by the need for use of flare prophylaxis.

All participants will have a smart phone application (GoutSMART) uploaded to their smart phones. Usual care participants will have a limited version of the GoutSMART application installed which includes background information about gout and provides a means for participants to maintain diaries of gout flares. Subjects in the usual care arm of the study will have treatment escalation decisions made by their GPs. Subjects in the treat-to-target arm will be taught to self-test serum urate using a BeneCheck Plus hand held device and provided with test strips. A full version of the GoutSMART application will be installed with the features mentioned above but also the facility to record a urate diary. Participants will be prompted to check their serum urate and enter the results into the GoutSMART application. Participants reporting a urate level \&gt;0.3mmol/l will be advised to increase the dose of allopurinol incrementally as specified in their treatment plan. No change will be advised in those whose urate levels are already at target. If the patient needs to increase allopurinol there will be an automatic reminder after two weeks prompting the patients to submit updated self-test results which will be handled in the same way as described above. Conversely for participants achieving target levels this will be acknowledged and a request to resubmit readings will be sent on a monthly basis.

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 \&gt;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.

Primary outcomes:
measure: Proportion of participants flare free in 2nd year of trial
timeFrame: 2nd year of trial
Secondary outcomes:
measure: Number of flares of gout
timeFrame: 2 years
measure: Urate targets of ≤0.3mmol/L or ≤0.36mmol/L
timeFrame: 2 years
measure: Presence of tophi
timeFrame: 2 years
measure: Societal cost
timeFrame: 2 years
measure: Time to remission
timeFrame: 2 years
measure: User engagement
timeFrame: 2 years
measure: Medication prescriptions
timeFrame: 2 years
measure: Quality of life using SF-36 questionnaire
timeFrame: 2 years
measure: Activity limitation
timeFrame: 2 years
measure: Medication compliance
timeFrame: 2 years
measure: Cost-effectiveness
timeFrame: 2 years
measure: Cost-Utility
timeFrame: 2 years
measure: Patient attitudes and understanding
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: NHS Lothian
name: Philip L Riches, FRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Riches PL, Alexander D, Hauser B, Kuske B, Krause A. Evaluation of supported self-management in gout (GoutSMART): a randomised controlled feasibility trial. Lancet Rheumatol. 2022 May;4(5):e320-e328. doi: 10.1016/S2665-9913(22)00062-5. Epub 2022 Mar 24.