GOut TrEatment STrategy (GO TEST) FINALE study, a multicentre, pragmatic, randomized superiority trial of continuation versus cessation of urate lowering therapies in gout in remission.

Recruiting

Conditions: Inflammatoire artritis
10023213
Gout
arthritis urica

Registration Number: NL-OMON52436

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 310

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 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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the difference in proportion of patients fulfilling an<br /><br>adapted version of the preliminary remission criteria for gout (no tophi, no<br /><br>flares, NRS pain due to gout < 2, NRS gout disease activity <2) over the last<br /><br>six months of 24 months follow up between the T2T and T2S strategy group. The<br /><br>adaptation consist of omitting the SU target < 0.36 prerequisite, as this<br /><br>surrogate outcome measure is of course not a realistic goal when<br /><br>comparing T2T and T2S. </p><br>

Secondary Outcome Measures