Gout, arthritis urica MedDRA version: 20.0 Level: PT Classification code 10018627 Term: Gout System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Allopurinol, Desuric, Adenuric
Pharmaceutical Form: Tablet
INN or Proposed INN: Allopurinol
CAS Number: 315-30-0
INN or Proposed INN: BENZBROMARONE
CAS Number: 3562-84-3
INN or Proposed IN
Sponsors
Sint Maartenskliniek
Eligibility
Sex/Gender
All
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 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 =65 years) yes F.1.3.1 Number of subjects for this age range 200
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 <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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 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 < 2, NRS gout disease activity <2) over the last six months of 24 months follow up between the T2T and T2S strategy group. The adaptation consist of omitting the SU target < 0.36 prerequisite, as this surrogate outcome measure is of course not a realistic goal when comparing T2T and T2S. ;Timepoint(s) of evaluation of this end point: The primary outcome is measured in the last six months of 24 month follow-up (month 18-24).;Main Objective: To test whether the proportion of patients in remission during the last 6 months of follow up is higher for a T2T strategy (in which the urate lowering therapies allopurinol, benzbromarone and/or febuxostat are continued) compared to a T2S stop strategy (in which the urate lowering therapies allopurinol, benzbromarone and/or febuxostat are tapered to stop). ;Secondary Objective: - To assess non-inferiority of T2S compared to T2T in case superiority of T2T over T2S is not shown in the primary analysis - To assess the incremental cost-effectiveness of T2T over T2S treatment strategy in euro per QALY gained - To assess the between group difference in the incidence of gout flares during the follow-up period of 24 months - To assess the proportion of participants that require reintroduction of ULT in the T2S strategy group - To evaluate the between group difference in Patient-Reported Outcome Measures (PROMs) - To assess the between group difference in types and frequency of adverse events during the follow-up period of 24 months - To assess the between group difference in use of ULT and flare medication (colchicine, NSAIDS and/or glucocorticoids) - To assess the between group difference in prescribed medication compared with refill rates and self-reported adherence during the follow-up period of 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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-5D-5L, 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 follow-up period of 24 months - The between group difference in use of ULT and flare medication (colchicine, NSAIDs and/or glucocorticoids) - 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, immunological and genetic variables. - The creation of a biobank consisting of serum, plasma and PAXgene samples of gout patients in remission (dis)continuing ULT ;Timepoint(s) of evaluation of this end point: Measurements take place at baseline, month 12 and 24. Two weeks after ULT discontinuation an extra blood visit is scheduled. Flares are monitored throughout the entire follow-up period; patients are required to call when a flare occurs and flares are monitored monthly by a digital questionnaire. | — |
Countries
Netherlands
Contacts
Public ContactJunior Investigator
Sint Maartenskliniek
Outcome results
None listed