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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04733079
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact	Korng EA, PH-PU
Phone	1 49 95 88 25
Email	hang-korng.ea@aphp.fr
Status	Recruiting
Phase	N/A
Start date	December 15, 2021
Completion date	October 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms