Treat-to-target by Email During Urate-lowering Therapy in Gout (NCT04733079) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout)