No registrations found.
ID
Source
Brief title
Health condition
Gout
Sponsors and support
Intervention
Outcome measures
Primary outcome
The GO TEST OVERTURE study aims to demonstrate the superiority of the T2T management strategy
over a T2S approach in terms of clinical remission of gout symptoms.
Secondary outcome
• In case superiority of T2T cannot be established, non-inferiority of T2S vs T2T will be tested
• To assess the cost effectiveness of a T2T gout management strategy compared with T2S
• To assess the effect of both treatment strategies on secondary clinical endpoints
• To assess the effect of both treatment strategies on patient reported outcomes
• To assess the safety of both treatment strategies
Background summary
Urate Lowering Therapy (ULT) plays an important role in the management of gout, however it can be implemented through different strategies. In the absence of high-quality evidence, international guidelines disagree which management strategy is optimal. The Gout TrEatment STrategy project (GO TEST) aims to compare clinical outcomes and cost-effectiveness of the Treat to Target (T2T) versus the Treat to avoid Symptoms (T2S) management strategies at two different points of the gout patients 'journey. The research protocol describes the GO TEST OVERTURE study in which gout patients not currently receiving ULT will be randomized to T2T or T2S and followed up for two years.
Study objective
The T2T strategy is superior in obtaining gout remission compared to the T2S strategy, and cost-effective.
Study design
Baseline, T1 (1 year follow-up visit), T2 ( 2 year follow-up visit)
Intervention
T2T strategy, starting ULT with the goal of obtaining clinical remission and a SUA target
<0.36mmol/ or <0.30 mmol/l, intensifying ULT until targets are reached.
Inclusion criteria
To be eligible to participate in this study, a subject must meet all the following criteria:
• Patients with a clinical diagnosis of gout and/or fulfilling the 2015 ACR-EULAR criteria
• Indication for ULT
• No current use of ULT
Exclusion criteria
A potential participant will be excluded from the study if one or more of the following criteria have been
met:
• A strong Contraindication for allopurinol, benzbromarone AND febuxostat
• eGFR < 30ml/minute
• Insufficient mastery of Dutch language to fill out questionnaires
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9575 |
| CCMO | NL74873.091.20 |
| OMON | NL-OMON55282 |