Tight Control of Gouty Arthritis Compared to Usual Care (TICOGA)

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.

Study Overview

• Status: Recruiting
• Conditions: Gout
• Intervention / Treatment: Other: Treat-to-target; Other: 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 Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jo-Anne Robertson; Phone Number: 0131 242 3326; Email: resgov@accord.scot
• Study Contact Backup: Name: Philip L Riches, FRCP, PhD; Phone Number: +44 7944625313; Email: philip.riches@nhs.scot

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • Recruiting
    • NHS Lothian
    • Contact: Philip Riches

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treat-to-target; 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.	Other: Treat-to-target; Treatment to achieve urate target using supported self-management approach
Active Comparator: Usual care; 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.	Other: Usual Care; Treatment escalation by GP based on usual clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants flare free in 2nd year of trial	Proportion of participants flare free in 2nd year of trial	2nd year of trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of flares of gout	Number of flares of gout in year 1, year 2 and over whole course of trial	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	2 years
Presence of tophi	Proportion of participants with tophi at week 52 and 104	2 years
Societal cost	Number of days lost at work and number of medical appointments or hospital admissions due to gout	2 years
Time to remission	Time to last flare of gout and time to resolution of tophi	2 years
User engagement	User engagement with smartphone app (number of reminders needed for each submission)	2 years
Medication prescriptions	Medication compliance assessed by community prescriptions issued	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)	2 years
Activity limitation	Functional impact assessed with HAQ-DI questionnaire at week 52 and 104	2 years
Medication compliance	Medication compliance assessed by patient self-report at week 52 and 104	2 years
Cost-effectiveness	Cost per flare avoided	2 years
Cost-Utility	Cost per quality adjusted life year gained	2 years
Patient attitudes and understanding	Exploration of patient attitudes and understanding through qualitative interview	2 years

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Investigators: Principal Investigator: Philip L Riches, FRCP, PhD, NHS Lothian

Publications and helpful links

General 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.

Helpful Links

• University of Edinburgh trial website

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: gout; treat-to-target
• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Gout
• Other Study ID Numbers: AC22077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie results of specified outcomes will be shared after deidentification.
• IPD Sharing Time Frame: Deidentified information will be made available immediately following publication of trial results and be kept available for 5 years.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No