The Gout TrEatment STrategy Project (GO TEST) Overture trial

Recruiting

Conditions: Gout
Gouty arthritis
10023213

Registration Number: NL-OMON55282

Lead Sponsor: Viecuri Medisch Centrum voor Noord-Limburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 310

Inclusion Criteria

• Patients with a Clinical diagnosis of gout and/or fulfilling the 2015
ACR-EULAR criteria
• Hyperuricemia
• No current use of ULT

Exclusion Criteria

• A strong Contraindication for all allopurinol, benzbromarone AND febuxostat
ULT
• Kidney failuree defined as GFR < 30ml/minute
• Insufficient mastery of Dutch language to fill out questionnaires

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is superiority of T2T vs T2S in terms of the difference in<br /><br>proportion of patients fulfilling an adapted version of the preliminary<br /><br>remission criteria for gout (no tophi, no flares, NRS pain due to gout < 2, NRS<br /><br>disease activity <2 over the last six months of 24 months follow up </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Incremental net monetary benefit of T2T over T2S at cost-effectiveness ceilings<br /><br>ranging from ¤0 to ¤120.000 per Quality Adjusted Life year (QALY)<br /><br><br /><br>Proportion of patients achieving serum urate level at, or below, 0.3 mmol/l at<br /><br>12 and 24 months<br /><br><br /><br>Proportion of patients achieving serum urate level at, or below, 0.36 mmol/l at<br /><br>12 and 24 months<br /><br><br /><br>Proportion of patients developing clinically apparent tophi<br /><br><br /><br>Number of gout flares according to the Gaffo criteria from baseline to last<br /><br>follow up<br /><br><br /><br>Patient reported functional status by The Rapid-3 version of the Health<br /><br>Assessment Questionnaire-II from baseline over 24 months (3-monthly)<br /><br><br /><br>Pain by Numerical Rating Scale from baseline over 24 months (3-monthly)<br /><br><br /><br>Patient Global assessment of Disease Activity by Numerical rating scale from<br /><br>baseline over 24 months (3-monthly) </p><br>