ClinicalTrials.gg
Active, not recruitingNCT04733079GOUTEmailUpdated Feb 4, 2026

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

An interventional study of Cleanweb electronic messaging ePro and Usual follow-up in Gout, Inflammatory Rheumatism and Hyperuricemia, sponsored by Assistance Publique - Hôpitaux de Paris. Active, not recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Gout with a site in France — 5 open to participants now, 8 under way, 1 of them phase 3. Gout · France.

Planned enrollment
4th of 11
204 · median 200
Started
2021
with 1 other
No phase
5 of 18
none open now
Registered
10th of 18
by date
Lead sponsor
8 of 18
Assistance Publique - Hôpitaux de Paris

Among the 18 studies in Gout with a site in France, this one is the 4th largest by planned enrollment of the 11 interventional ones, is one of 2 that started in 2021, is one of 5 with no phase, and was the 10th registered.

By phase

18 studies; the count open now beside each. This study's row is marked.

Observational7 · 4 open
No phasethis study5 · 0 open
Phase 22 · 0 open
Phase 32 · 0 open
Phase 2/31 · 1 open
Phase 41 · 0 open

By the year they started

First in 2008; this study’s year is marked. 2 started in 2021.

Size and results

Median enrollment 200 across the 11 interventional studies, 240 across the 7 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.

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02

Study 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.

Read 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 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.

03

Conditions studied

  • Gout
  • Inflammatory Rheumatism
  • Hyperuricemia
  • Posology Adjustment

Keywords

  • Treat-to-target
  • Gout
  • Tophus
  • Urate crystals
  • Urate-lowering therapy
  • Febuxostat
  • Allopurinol
  • Therapeutic strategy
  • Electronic messaging
  • Therapeutic compliance
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
204 participants (estimated)

Study arms

  • 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

  • Active comparator
    Usual follow-up group

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

    Other: Usual follow-up

Interventions

  • OtherCleanweb 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

  • OtherUsual follow-up

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

06

What researchers measure

Primary outcomes

  1. Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout)

    Time frame: Month 12

Secondary outcomes

  1. Average dose of ULT (allopurinol and febuxostat)

    Time frame: Month 12

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2021 (actual). Primary completion is estimated for Apr 2026, 52 months after the start.

Of 34 non-industry interventional studies with no phase under Gout, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 52 months is above that.

Counting every sponsor, half of 35 studies reached it within 29 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2021
First posted
Feb 1, 2021
StartActual
Dec 15, 2021
Primary completionEst.
Apr 30, 2026
CompletionEst.
Dec 31, 2026
Last update
Feb 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04733079
Responsible party
Sponsor
First posted
Feb 1, 2021
Start date
Dec 15, 2021
Primary completion
Apr 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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