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NCT Number: NCT05507723

Tight Control of Gouty Arthritis Compared to Usual Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Lothian

Edinburgh, United Kingdom

Location status: Recruiting

Location contact

Philip Riches

CONTACT

About this study

A total of approximately 125 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 >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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treat-to-target

Other

Treatment to achieve urate target using supported self-management approach

Usual Care

Other

Treatment escalation by GP based on usual clinical practice

Primary outcomes

  1. Proportion of participants flare free in 2nd year of trial

    Time frame: 2nd year of trial

    Proportion of participants flare free in 2nd year of trial

Secondary outcomes

  1. Number of flares of gout

    Time frame: 2 years

    Number of flares of gout in year 1, year 2 and over whole course of trial

  2. Urate targets of ≤0.3mmol/L or ≤0.36mmol/L

    Time frame: 2 years

    Proportion of participants achieving urate levels of ≤0.3mmol/L or ≤0.36mmol/L at 52 and 104wks

  3. Presence of tophi

    Time frame: 2 years

    Proportion of participants with tophi at week 52 and 104

  4. Societal cost

    Time frame: 2 years

    Number of days lost at work and number of medical appointments or hospital admissions due to gout

  5. Time to remission

    Time frame: 2 years

    Time to last flare of gout and time to resolution of tophi

  6. User engagement

    Time frame: 2 years

    User engagement with smartphone app (number of reminders needed for each submission)

  7. Medication prescriptions

    Time frame: 2 years

    Medication compliance assessed by community prescriptions issued

  8. Quality of life using SF-36 questionnaire

    Time frame: 2 years

    Self-reported quality of life at week 52 and week 104 using SF 36 questionnaire. Global health score (0 to 100 score with 100 representing best possible health)

  9. Activity limitation

    Time frame: 2 years

    Functional impact assessed with HAQ-DI questionnaire at week 52 and 104

  10. Medication compliance

    Time frame: 2 years

    Medication compliance assessed by patient self-report at week 52 and 104

  11. Cost-effectiveness

    Time frame: 2 years

    Cost per flare avoided

  12. Cost-Utility

    Time frame: 2 years

    Cost per quality adjusted life year gained

  13. Patient attitudes and understanding

    Time frame: 2 years

    Exploration of patient attitudes and understanding through qualitative interview

Study contacts

Contact information is provided by the study sponsor or research team.

Jo-Anne Robertson

CONTACT

[email protected]

0131 242 3326

Philip L Riches, FRCP, PhD

CONTACT

[email protected]

+44 7944625313

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

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

Acronym: TICOGA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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