The Gout TrEatment STrategy Project (GO TEST) Overture trial

Phase 1

• Conditions: gout; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-005721-82-NL
• Lead Sponsor: VieCuri

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-20
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

•Patients with a Cclinical diagnosis of gout and/or fulfilling the 2015 ACR-EULAR criteria
•Hyperuricemia
•No current use of ULT
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 310
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 310

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Theo bjective of the trial is to compare two gout management strategies. Patients in both arms will initiate urate lowering therapy. The type of drugs and dosages are at the discretion of the rheumatologists. In the Treat to target arm, routine monitoring of serum urate will take place and treatment will be intensified in case predefined SUA target levels are not achieved. In the Treat to avoid symptoms arm, treatment will only be intensified in case of persisting or recurring symptoms. ;Secondary Objective: To compare cost-effectiveness, Patient reported outcomes and safety between treatment groups. ;Primary end point(s): 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 < 2, NRS disease activity <2 over the last six months of 24 months follow up;Timepoint(s) of evaluation of this end point: 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Incremental net monetary benefit of T2T over T2S at cost-effectiveness ceilings ranging from €0 to €120.000 per Quality Adjusted Life year (QALY)<br>•Proportion of patients achieving serum urate level at, or below, 0.30 mmol/l at 12 and 24 months<br>•Proportion of patients achieving serum urate level at, or below, 0.36 mmol/l at 12 and 24 months<br>•Proportion of patients developing clinically apparent tophi<br>•Number of gout flares according to the Gaffo criteria from baseline to last follow up<br>•Mean change in Ppatient reported functional status by The Rapid-3 version of the Health Assessment Questionnaire-II from baseline over 24 months (3-monthly)<br>•Mean change in Ppain by Numerical Rating Scale from baseline over 24 months (3-monthly)<br>•Mean change in Ppatient Global assessment of Disease Activity by Numerical rating scale from baseline over 24 months (3-monthly)<br>;Timepoint(s) of evaluation of this end point: 3 monthly starting from baseline