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Tight Control of Gouty Arthritis Compared to Usual Care

Study acronym: TICOGA
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Eligibility criteria expanded, about 10 words · Secondary endpoints: details revised at 2 of 13 entries · Study description revised · 2 more Show 5 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 13 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Enrollment target: 120 to 125 Study description revisedv9 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jun 1, 2025 to Jun 12, 2025v8 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2025 to Jun 12, 2025
  4. Start date: Mar 3, 2025 to Jun 1, 2025 Primary completion date: Dec 31, 2027 to May 31, 2028 · Completion date: Jul 31, 2028 to Dec 31, 2028v7 Show 2 more changesShow less
    • Primary completion date: Dec 31, 2027 to May 31, 2028
    • Completion date: Jul 31, 2028 to Dec 31, 2028
  5. Start date: Jan 3, 2025 to Mar 3, 2025v6
Show 4 earlier versionsHide 4 earlier versions
  1. Enrollment target: 240 to 120 Primary completion date: Dec 2026 to Dec 31, 2027 · Start date: Oct 2024 to Jan 3, 2025 · Completion date: Dec 2027 to Jul 31, 2028 · 4 morev5 Show 7 more changesShow less
    • Primary completion date: Dec 2026 to Dec 31, 2027
    • Start date: Oct 2024 to Jan 3, 2025
    • Completion date: Dec 2027 to Jul 31, 2028
    • Interventions: Treat-to-flare (Other), Treat-to-target (Other) to Treat-to-target (Other), Usual Care (Other)
    • Secondary endpoints: 11 to 13
    • Eligibility criteria shortened, about 4 words
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Jan 2024 to Oct 2024v4
  3. Study description shortened, about 24 words Study title shortened, about 2 wordsv3 Show 1 more changeShow less
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Dec 2025 to Dec 2026 Start date: Jan 2023 to Jan 2024 · Completion date: Dec 2026 to Dec 2027v2 Show 2 more changesShow less
    • Start date: Jan 2023 to Jan 2024
    • Completion date: Dec 2026 to Dec 2027
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05507723
Lead Sponsor University of Edinburgh
Conditions Gout
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov