Active — Not RecruitingNot Applicable

Treat-to-target by Email During Urate-lowering Therapy in Gout

France204 participantsStarted 2021-12-15

Plain-language summary

Gout is secondary to urate crystal deposition after chronic elevation of serum urate level (SUL). Long-term lowering SUL below 360 µmol/L allows dissolution of deposited crystals and disease cure. There is currently a paradoxical observation: while urate-lowering therapy (ULT) is available and efficient there is an increase of gout prevalence and severity. The apparent failure of ULT in gout management is due to several causes including unadjusted dosage, no SUL verification, irregular follow-up and low treatment compliance. In contrast, a nurse-led treat-to-target (T2T) strategy with regular adaptations of ULT until reaching SUL target allows gout cure in more than 90% of patients. We hypothesize that an electronic messaging-led T2T strategy will allow obtaining similar results. The aim of this study is to demonstrate that email-led T2T strategy during ULT is superior to usual care.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged over 18 years old * Gout confirmed by identification of urate crystals by joint fluid or tophus analysis or by ultrasound of the affected joint or * Gout according to Nijmegen criteria (presence of a score ≥ 8/13) depending on the following items: Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1) (2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease (1.5 pts) SUL \> 360 μmol/l during the crisis (3.5 pts) * Patients without ULT or with an ineffective ULT defined by an SUL \> 360 μmol/l in intercritical pahse * Patients who routinely use e-mail Exclusion Criteria: * Participating in another trial including the administration of a drug * Patients treated with azathioprine * Patients intolerant to hypouricemic treatments * Unable to use the internet * Difficulty understanding French * Illiteracy * Pregnant womenor breastfeeding mothers (see PHC article L.1121-5) * Persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Sections L. 3212-1 and L. 3213-1 and persons admitted to a health or social institution for purposes other than research (see CSP Article L.1121-6) * Major persons subject to a measure of legal protection or unseeding to express consent (see PHC Article L.1121-8) * Persons not affiliated to a social security plan or beneficiaries of such a plan (see PHC Article L.1121-8-1)

What they're measuring

Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout)

Timeframe: Month 12

Trial details

NCT IDNCT04733079

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30