Status:
ACTIVE_NOT_RECRUITING
Treat-to-target by Email During Urate-lowering Therapy in Gout
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Gout
Inflammatory Rheumatism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. The...
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 fol...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 28 2025
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT04733079
Start Date
December 15 2021
End Date
August 28 2025
Last Update
September 3 2025
Active Locations (2)
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1
Hopital LARIBOISIERE - Rhumatologie
Paris, PARIS, France, 75010
2
Rhumathology department
Paris, Île-de-France Region, France, 75010