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

February 2, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hopital LARIBOISIERE - Rhumatologie
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75010
        • Rhumathology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout)
Time Frame: Month 12
Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Average dose of ULT (allopurinol and febuxostat)
Time Frame: Month 12
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 24, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 1, 2021

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP180167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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