We hypothesize that the T2T strategy is superior compared to the T2S in retaining gout remission and is also more cost-effective.
ID
Bron
Verkorte titel
Aandoening
- Gewrichtsaandoeningen
Aandoening
Gout, arthritis urica
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is 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 gout disease activity <2) over the last six months of 24 months follow up between the T2T and T2S strategy group. The adaptation consist of omitting the SU target < 0.36 prerequisite, as this surrogate outcome measure is of course not a realistic goal when comparing T2T and T2S.
Achtergrond van het onderzoek
Urate lowering therapies (ULT) are used in patients with gout to lower serum urate (SU) levels to prevent crystal depositions which can result in inflammation. Rheumatology guidelines recommend the use of ULT by the so-called treat-to-target strategy (T2T); SU levels should be <0.36 mmol/l or <0.30 mmol/l in severe gout, by increasing or combining ULT until the target has been reached. Due to the chronicity of gout, the high safety and low costs of ULT, most experts therefore advise to use ULT lifelong. However, a different, frequently used method (mainly by patients themselves or general practitioners, GPs) is a treat-to-symptom strategy (T2S), which only aims at a patient acceptable symptom state, regardless of SU levels. ULT are often stopped when in remission and are restarted when gout flares reoccur (too often). Although most rheumatologists strongly belief that the T2T approach is superior to T2S, high quality evidence to support either of the strategies is lacking, both in the induction phase but especially in the maintenance phase. We hypothesize that the T2T strategy is superior compared to the T2S in retaining gout remission and is also more cost-effective.
Doel van het onderzoek
We hypothesize that the T2T strategy is superior compared to the T2S in retaining gout remission and is also more cost-effective.
Onderzoeksopzet
Visits: baseline, 2 weeks after ULT cessation, month 12, month 24 Questionnaires: flare monitoring monthly, other PROMs and medical costs three monthly
Onderzoeksproduct en/of interventie
Continuation or tapering to stop of urate lowering therapy
Publiek
Wetenschappelijk
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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 interleukin-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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
p/a Radboudumc, huispost 628,
Postbus 9101
6500 HB Nijmegen
024 361 3154
commissiemensgebondenonderzoek@radboudumc.nl
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In overige registers
Register | ID |
---|---|
NTR-new | NL9245 |
CCMO | NL74350.091.20 |
EudraCT | 2020-005730-15 |
OMON | NL-OMON52436 |