GoutTICOGANCT05507723
Tight Control of Gouty Arthritis Compared to Usual Care
A study testing Treat-to-target in people with Gout, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout
- What is being tested?
- Treat-to-target
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2025to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tight Urate Control in Gouty Arthritis Compared to Usual Care (TICOGA), a Randomised Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Gout
- Being tested
- Treat-to-target, Usual Care
- Keywords
- treat-to-target, gout
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treat-to-targetOther
Treatment to achieve urate target using supported self-management approach
Usual CareOther
Treatment escalation by GP based on usual clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Treat-to-target | Experimental | 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. Receives: Other: Treat-to-target |
| Usual care | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants flare free in 2nd year of trial
Proportion of participants flare free in 2nd year of trial
Measured: 2nd year of trial
Secondary outcomes (13)
Number of flares of gout
Number of flares of gout in year 1, year 2 and over whole course of trial
Measured: 2 years
Urate targets of ≤0.3mmol/L or ≤0.36mmol/L
Proportion of participants achieving urate levels of ≤0.3mmol/L or ≤0.36mmol/L at 52 and 104wks
Measured: 2 years
Presence of tophi
Proportion of participants with tophi at week 52 and 104
Measured: 2 years
Societal cost
Number of days lost at work and number of medical appointments or hospital admissions due to gout
Measured: 2 years
Time to remission
Time to last flare of gout and time to resolution of tophi
Measured: 2 years
User engagement
User engagement with smartphone app (number of reminders needed for each submission)
Measured: 2 years
Medication prescriptions
Medication compliance assessed by community prescriptions issued
Measured: 2 years
Quality of life using SF-36 questionnaire
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)
Measured: 2 years
Activity limitation
Functional impact assessed with HAQ-DI questionnaire at week 52 and 104
Measured: 2 years
Medication compliance
Medication compliance assessed by patient self-report at week 52 and 104
Measured: 2 years
Cost-effectiveness
Cost per flare avoided
Measured: 2 years
Cost-Utility
Cost per quality adjusted life year gained
Measured: 2 years
Patient attitudes and understanding
Exploration of patient attitudes and understanding through qualitative interview
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start12 Jun 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip L Riches, FRCP, PhD, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507723
- Sponsor's protocol ID
- AC22077
- Acronym
- TICOGA
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results of specified outcomes will be shared after deidentification.
Publications
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.
PubMed 38294032