Tight Control of Gouty Arthritis Compared to Usual Care

NCT05507723 | Recruiting

• 1 other identifier: AC22077
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout

Keywords

treat-to-target; gout

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Number of flares of gout

  2 years

• Urate targets of ≤0.3mmol/L or ≤0.36mmol/L

  2 years

• Presence of tophi

  2 years

• Societal cost

  2 years

• Time to remission

  2 years

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

Treat-to-target OTHER

Treatment to achieve urate target using supported self-management approach

Treat-to-target

Usual Care OTHER

Treatment escalation by GP based on usual clinical practice

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 38294032 BACKGROUND

Related Links

• University of Edinburgh trial website

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Philip L Riches, FRCP, PhD

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip L Riches, FRCP, PhD

CONTACT

+44 7944625313; philip.riches@nhs.scot

Jo-Anne Robertson

CONTACT

0131 242 3326; resgov@accord.scot

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 19, 2022
• Study Start: June 12, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deidentified information will be made available immediately following publication of trial results and be kept available for 5 years.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

GB (1)