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Tight Control of Gouty Arthritis Compared to Flare Based Treatment Escalation (TICOGA)

Primary Purpose

Gout

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treat-to-target
Treat-to-flare
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gout

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 or established liver disease
  • Current prescription of medication known to interact with xanthine oxidase inhibitors such as azathioprine or mercapto-purine.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treat-to-target

    Treat-to-flare

    Arm Description

    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.

    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. Participants in the treat-to-flare arm of the study will be reviewed every 4 months and allopurinol dose escalated incrementally if they have sustained a gout flare in the preceding 4 months, up to the maximum pre-specified allopurinol dose.

    Outcomes

    Primary Outcome Measures

    Proportion of participants flare free in 2nd year of trial
    Proportion of participants flare free in 2nd year of trial

    Secondary Outcome Measures

    Number of flares of gout
    Number of flares of gout in year 1, year 2 and over whole course of trial
    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
    Medication compliance
    Medication compliance assessed by patient self-report
    Presence of tophi
    Proportion of participants with tophi at week 52 and 104
    Quality of life using Eq-5D-5L (Euroqol-5 dimension-5 level instrument)
    Self-reported quality of life at week 52 and week 104 using global health score (0 to 100 score with 100 representing best possible health)
    Societal cost
    Number of days lost at work and number of medical appointments or hospital admissions due to gout
    Time to remission
    Time to last flare of gout and time to resolution of tophi
    User engagement
    User engagement with smartphone app (number of reminders needed for each submission)
    Lifestyle changes
    Proportion of patients adopting lifestyle changes
    Medication prescriptions
    Medication compliance assessed by community prescriptions issued
    Medication metabolite level
    Assessed by urinary oxypurinol measure

    Full Information

    First Posted
    July 22, 2022
    Last Updated
    May 12, 2023
    Sponsor
    University of Edinburgh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05507723
    Brief Title
    Tight Control of Gouty Arthritis Compared to Flare Based Treatment Escalation
    Acronym
    TICOGA
    Official Title
    Effect of Tight Urate Control in Gouty Arthritis Compared to Flare Based Treatment Escalation (TICOGA), a Randomised Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    December 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Edinburgh

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 treatment guided by symptoms only.
    Detailed Description
    A total of approximately 240 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. Treat-to-flare 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 and quality of life. Subjects in the treat-to-flare arm of the study will be reviewed remotely every 4 months and if they have suffered a flare in that time will be advised to increase their dose of allopurinol incrementally as specified in their treatment plan. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gout

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized clinical trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treat-to-target
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Treat-to-flare
    Arm Type
    Active Comparator
    Arm Description
    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. Participants in the treat-to-flare arm of the study will be reviewed every 4 months and allopurinol dose escalated incrementally if they have sustained a gout flare in the preceding 4 months, up to the maximum pre-specified allopurinol dose.
    Intervention Type
    Other
    Intervention Name(s)
    Treat-to-target
    Intervention Description
    Treatment to achieve urate target using supported self-management approach
    Intervention Type
    Other
    Intervention Name(s)
    Treat-to-flare
    Intervention Description
    Treatment escalation based on reported flares of gout
    Primary Outcome Measure Information:
    Title
    Proportion of participants flare free in 2nd year of trial
    Description
    Proportion of participants flare free in 2nd year of trial
    Time Frame
    2nd year of trial
    Secondary Outcome Measure Information:
    Title
    Number of flares of gout
    Description
    Number of flares of gout in year 1, year 2 and over whole course of trial
    Time Frame
    2 years
    Title
    Urate targets of ≤0.3mmol/L or ≤0.36mmol/L
    Description
    Proportion of participants achieving urate levels of ≤0.3mmol/L or ≤0.36mmol/L at 52 and 104wks
    Time Frame
    2 years
    Title
    Medication compliance
    Description
    Medication compliance assessed by patient self-report
    Time Frame
    2 years
    Title
    Presence of tophi
    Description
    Proportion of participants with tophi at week 52 and 104
    Time Frame
    2 years
    Title
    Quality of life using Eq-5D-5L (Euroqol-5 dimension-5 level instrument)
    Description
    Self-reported quality of life at week 52 and week 104 using global health score (0 to 100 score with 100 representing best possible health)
    Time Frame
    2 years
    Title
    Societal cost
    Description
    Number of days lost at work and number of medical appointments or hospital admissions due to gout
    Time Frame
    2 years
    Title
    Time to remission
    Description
    Time to last flare of gout and time to resolution of tophi
    Time Frame
    2 years
    Title
    User engagement
    Description
    User engagement with smartphone app (number of reminders needed for each submission)
    Time Frame
    2 years
    Title
    Lifestyle changes
    Description
    Proportion of patients adopting lifestyle changes
    Time Frame
    2 years
    Title
    Medication prescriptions
    Description
    Medication compliance assessed by community prescriptions issued
    Time Frame
    2 years
    Title
    Medication metabolite level
    Description
    Assessed by urinary oxypurinol measure
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 or established liver disease Current prescription of medication known to interact with xanthine oxidase inhibitors such as azathioprine or mercapto-purine.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Philip L Riches, FRCP, PhD
    Phone
    07944625313
    Email
    philip.riches@nhslothian.scot.nhs.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jo-Anne Robertson
    Phone
    0131 242 3326
    Email
    resgov@accord.scot
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Philip L Riches, FRCP, PhD
    Organizational Affiliation
    NHS Lothian
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.

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