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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04733079

Collaborator

(none)

204

Enrollment

Locations

Arms

33.5

Anticipated Duration (Months)

102

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Gout Inflammatory Rheumatism Hyperuricemia Posology Adjustment	Other: Cleanweb electronic messaging ePro Other: Usual follow-up	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 15, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: E-mail follow-up group Email-led treat-to-target strategy with regular adaptation of ULT via electronic messaging	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
Active Comparator: Usual follow-up group Adaptation and follow-up of ULT according to referring physician's habits	Other: Usual follow-up Adaptation and follow-up of ULT according to referring physician's habits

Arm

Intervention/Treatment

Experimental: E-mail follow-up group

Email-led treat-to-target strategy with regular adaptation of ULT via electronic messaging

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

Active Comparator: Usual follow-up group

Adaptation and follow-up of ULT according to referring physician's habits

Other: Usual follow-up

Adaptation and follow-up of ULT according to referring physician's habits

Outcome Measures

Primary Outcome Measures

Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout) [Month 12]

Secondary Outcome Measures

Average dose of ULT (allopurinol and febuxostat) [Month 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)