NCT04733079

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will include 204 gouty patients without ULT or with ineffective ULT. This is a multicenter and randomized study (e-mail follow-up vs usual follow-up groups). This study will include the following visits: * Selection/inclusion visit (V0): * If available biological data (leucocyte count, hemoglobin level, creatininemia and estimated glomerular filtration rate (eGFR), SUL) were assessed during the last month, , included patient will be randomized at the end of the consultation to follow either an email-led T2T strategy or usual ULT care. * In the absence of biological results, the patient will be reviewed within the month with blood analysis and then randomized. * Follow-up visits: consultations will be carried out according to the usual care of the referring physician. * Visit M12 end of research: clinical evaluation of gout, demographic characteristics, medication, type and dose of ULT, blood analysis (serum creatinine level, eGFR, SUL). The study ends after the M12 consultation. The total duration of participation in the study is 12 months.

Conditions

• Gout
• Inflammatory Rheumatism
• Hyperuricemia
• Posology Adjustment

Interventions

Type	Name	Description
OTHER	Cleanweb electronic messaging ePro	Patient and their medecin will communicate regulary via Cleanweb electronic messaging ePro to adapt the posology of THU untill the target urecemia is reached
OTHER	Usual follow-up	Adaptation and follow-up of ULT according to referring physician's habits

Timeline

• Start date: 2021-12-15
• Primary completion: 2026-04-30
• Completion: 2026-12-31
• First posted: 2021-02-01
• Last updated: 2026-02-04

Locations

2 sites across 1 country: France