Informations générales (source: ClinicalTrials.gov)
Treat-to-target by Email During Urate-lowering Therapy in Gout (GOUTEmail)
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
décembre 2021
août 2025
05 avril 2025
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.
Etablissements
Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
---|---|---|---|---|---|
AP-HP - Hôpital Bichat | EA Hang Korng | 02/12/2024 12:46:30 | Contacter | ||
AP-HP - Hôpital Lariboisiere-Fernand Widal | EA Hang Korng | 02/12/2024 12:46:30 | Contacter | ||
AP-HP - Hôpital Tenon | EA Hang Korng | 02/12/2024 12:46:30 | Contacter | ||
CHI DE CRETEIL | Etienne GAZAIX FONTAINE | 01/04/2025 09:49:19 | Contacter | ||
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
Rhumathology department - 75010 - Paris - Ile-De-France - France | Contact (sur clinicalTrials) |
Critères
Tous
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
- 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
- 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)