Inflammatoire artritis arthritis urica Gout
Conditions
Interventions
The intervention group employs the T2T strategy, in which ULT are continued and
a SU target of 1 flare or a flare duration of >1 week
under adequate flare treatment during follow-up time, ULT are re
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a participant must meet all of the following criteria: - 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 o Pain due to gout =18 years and mentally competent - Signed written informed consent
Exclusion criteria
Exclusion criteria: A potential participant will be excluded from participation in this study if one of the following criteria has been met: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the difference in proportion of patients fulfilling an adapted version of the preliminary remission criteria for gout (no tophi, no flares, NRS pain due to gout | — |
Secondary
| Measure | Time frame |
|---|---|
| - Non-inferiority of T2S compared to T2T with a predefined NI-margin of 0.08, in case superiority of T2T over T2S is not shown in the primary analysis. * The incremental cost-effectiveness of T2T over T2S treatment strategy in euro per QALY gained, by using the results of EQ-5D-5L, iMCQ, iPCQ and medication costs - The between group difference in the incidence (cumulative incidence and incidence density rate) of gout flares during the follow-up period of 24 months - The proportion of participants that require reintroduction of ULT in the T2S group during the 24 month follow-up period - The between group difference in SU change during the total follow-up time and particularly at baseline and at the end of follow-up at 24 months - The between group difference in PROMs at baseline and after 24 months by using the EQ-5D5L, HAQ-II, NRS pain, and NRS global health - The between group difference in types and frequency of adverse events, with special focus on change in renal function (CKD-EPI), incidence of cardiovascular events during the followup period of 24 months - The between group difference in use of ULT and flare medication (colchicine, NSAIDs and/or prednisone) - The (between group) difference in prescribed medication compared with refill rates during the follow-up period of 24 months - An overview of predictors for successful ULT cessation in the T2S strategy group including clinical, radiological and immunological variables. - The creation of a biobank consisting of serum, plasma and PAXgene samples of gout patients in remission (dis)continuing ULT | — |
Countries
Netherlands
Outcome results
None listed