GoutGOUTEmailNCT04733079
Treat-to-target by Email During Urate-lowering Therapy in Gout
A study testing Cleanweb electronic messaging ePro and Usual follow-up in people with Gout and Inflammatory Rheumatism, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout, Inflammatory Rheumatism, Hyperuricemia
- What is being tested?
- Cleanweb electronic messaging ePro and Usual follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Dec 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital LARIBOISIERE - Rhumatologie
Paris, 75010
Rhumathology department
Paris, Île-de-France Region, 75010
About this study
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.
- Conditions
- Gout, Inflammatory Rheumatism, Hyperuricemia, Posology Adjustment
- Being tested
- Cleanweb electronic messaging ePro, Usual follow-up
- Keywords
- Treat-to-target, Gout, Tophus, Urate crystals, Urate-lowering therapy, Febuxostat, Allopurinol, Therapeutic strategy, Electronic messaging, Therapeutic compliance
- Medical subject headings
- Gout, Rheumatic Fever, Hyperuricemia, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleanweb electronic messaging eProOther
Patient and their medecin will communicate regulary via Cleanweb electronic messaging ePro to adapt the posology of THU untill the target urecemia is reached
Usual follow-upOther
Adaptation and follow-up of ULT according to referring physician's habits
| Study group | Role | What they receive |
|---|---|---|
| E-mail follow-up group | Experimental | Email-led treat-to-target strategy with regular adaptation of ULT via electronic messaging Receives: Other: Cleanweb electronic messaging ePro |
| Usual follow-up group | Active comparator | Adaptation and follow-up of ULT according to referring physician's habits Receives: Other: Usual follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout)
Measured: Month 12
Secondary outcomes (1)
Average dose of ULT (allopurinol and febuxostat)
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start15 Dec 2021
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733079
- Sponsor's protocol ID
- APHP180167
- Acronym
- GOUTEmail
- Status last verified
- Apr 2025
- First submitted
- 24 Jan 2021
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treat-to-target by Email During Urate-lowering Therapy in Gout
- ClinicalTrials.gov ID
- NCT04733079
- Acronym / sponsor ID
- GOUTEmail / APHP180167
- Conditions
- Gout, Inflammatory Rheumatism, Hyperuricemia, Posology Adjustment
- Keywords
- Treat-to-target, Gout, Tophus, Urate crystals, Urate-lowering therapy, Febuxostat, Allopurinol, Therapeutic strategy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-mail follow-up group | Experimental | Other: Cleanweb electronic messaging eProEmail-led treat-to-target strategy with regular adaptation of ULT via electronic messaging |
| Usual follow-up group | Active comparator | Other: Usual follow-upAdaptation and follow-up of ULT according to referring physician's habits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cleanweb electronic messaging eProPatient and their medecin will communicate regulary via Cleanweb electronic messaging ePro to adapt the posology of THU untill the target urecemia is reached | Other | E-mail follow-up group |
| Usual follow-upAdaptation and follow-up of ULT according to referring physician's habits | Other | Usual follow-up group |
Primary outcome
Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout)
Time frame: Month 12
1 secondary outcome
Average dose of ULT (allopurinol and febuxostat)
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleanweb electronic messaging ePro and Usual follow-up in people with Gout and Inflammatory Rheumatism, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout) (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.