The Gout TrEatment STrategy Project (GO TEST) Overture trial

The Gout TrEatment STrategy Project (GO TEST) Overture trial - GO TEST OVERTURE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55282

Enrollment

310

Registered

2021-01-20

Start date

2021-03-04

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Interventions

Treat to Target Patients in this group will be treated in accordance with the guidelines issued by the Dutch association for rheumatology (NVR) and the *European League against rheumatism* (EULAR)

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)