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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tight Urate Control in Gouty Arthritis Compared to Usual Care (TICOGA), a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05507723
- Acronym / sponsor ID
- TICOGA / AC22077
- Conditions
- Gout
- Keywords
- treat-to-target, gout
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Treat-to-target | Experimental | Other: Treat-to-targetAll 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. |
| Usual care | Active comparator | Other: Usual CareAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treat-to-targetTreatment to achieve urate target using supported self-management approach | Other | Treat-to-target |
| Usual CareTreatment escalation by GP based on usual clinical practice | Other | Usual care |
Primary outcome
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
13 secondary outcomes
Number of flares of gout
Time frame: 2 years
Urate targets of ≤0.3mmol/L or ≤0.36mmol/L
Time frame: 2 years
Presence of tophi
Time frame: 2 years
Societal cost
Time frame: 2 years
Time to remission
Time frame: 2 years
User engagement
Time frame: 2 years
Medication prescriptions
Time frame: 2 years
Quality of life using SF-36 questionnaire
Time frame: 2 years
Activity limitation
Time frame: 2 years
Medication compliance
Time frame: 2 years
Cost-effectiveness
Time frame: 2 years
Cost-Utility
Time frame: 2 years
Patient attitudes and understanding
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 38294032Riches 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.
- University of Edinburgh trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results of specified outcomes will be shared after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip L Riches, FRCP, PhD principal investigator
NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treat-to-target in people with Gout, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants flare free in 2nd year of trial (time frame: 2nd year of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05507723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.