GO TEST FINALE

Phase 1

Conditions: Gout
MedDRA version: 20.0Level: LLTClassification code: 10003257Term: Arthritis gouty Class: 10028395
MedDRA version: 21.0Level: LLTClassification code: 10003435Term: Articular gout Class: 10027433
MedDRA version: 20.0Level: PTClassification code: 10018627Term: Gout Class: 100000004861
MedDRA version: 21.1Level: LLTClassification code: 10064900Term: Gout flare Class: 10027433
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: CTIS2024-511111-13-01

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 310

Inclusion 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

- 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