GO TEST FINALE
EU CTIS ID: 2024-511111-13-01
What this study is testing
1) To assess the between strategy difference in proportion of participants fulfilling adapted preliminary gout remission criteria (no tophi, no flares, NRS pain due to gout <2 and disease activity <2, but independent of sUA level), during the last six months of the 24 month follow-up period. 2) To assess the incremental cost-effectiveness in euro per QALY gained for T2T compared to T2S.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Patients with clinical diagnosis of gout and/or fulfilling the 2015 ACR-EULAR gout criteria
- - Use of ULT (allopurinol, benzbromarone and/or febuxostat)
- Achieved remission for ≥ 12 months based on adapted preliminary gout remission criteria (29). o Free of flares and/or clinically apparent tophi during the last 12 months o Serum urate ≤0.36 mmol/l at baseline and all values in the last 12 months should not be >0.36 mmol/l o Pain due to gout <2 using a 10-point Likert-type scale at baseline o Patient global assessment of gout disease activity <2 using a 10-point Likert-type scale at baseline
- Age ≥18 years and mentally competent
- Signed written informed consent
You likely can't join if
- - Not being able to speak, read or write Dutch well enough
- No ability to measure the outcome of the study in the participant (e.g. life expectancy <2 years, planned relocation out of reach of study center)
- A strong contra-indication for glucocorticoids, NSAIDs AND colchicine, as this hampers flare treatment
- Use of ULT (also) for any other indication than gout (for example nephrolithiasis)
- Currently taking regular glucocorticoids, and/or colchicine, and/or interleukine-1 inhibitors for any diagnosis and/or the use of regular NSAID intake for gout activity
- A history of myocardial infarction or stroke in the past six months and/or congestive heart failure NYHA class III or IV
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.