GoutPhase 3FEFACRIGOUNCT05109936
Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration
A Phase 3 study testing Adenuric in people with Gout, run by University Hospital, Rouen at 6 sites in France.
Trial summary
Gout, the most common inflammatory rheumatism in France, is a complication of chronic hyperuricemia (> 360umol / l). The resulting urate crystals are deposited in many tissues, especially the skeletal or kidneys. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout
- What is being tested?
- Adenuric
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 6 sitesFrance
- Study dates
- 2 Aug 2023to 10 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients with an attack of gout, diagnosed immediately or less than 5 days old. Gout is defined according to American-European criteria (Appendix 3).
- Attack of gout affecting one (or more) peripheral joint (s) whatever (s) it (s):
- Either a first crisis,
- Either a new attack of a gout not treated with a hypo-uricemic or for which the hypo-uricemic treatment has not been taken for at least 6 months.
- Uricemia ≥ 420 µmol / l, including under a diuretic (dosage carried out within 10 days before inclusion),
- Age ≥ 18 years old,
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- Patient with a creatinine clearance ≥ 30 ml / min (dosage carried out within 10 days before inclusion),
- Patient having read and understood the information letter and signed the consent form,
- Affiliation to a social security scheme,
- Woman of childbearing potential with effective contraception according to WHO definition (estrogen-progestins or intrauterine device or tubal ligation for more than 1 month and to be continued for at least 5 weeks after the last dose of the drug. ) and a negative urine pregnancy test on inclusion and throughout the duration of the study Where Postmenopausal woman: amenorrhea not medically induced for at least 12 months before the inclusion visit.
Who cannot join
- Patients under the age of 18,
- Stop taking a hypouricemic agent for less than 6 months,
- Known contraindication to ADENURIC 80 mg film-coated tablet: hypersensitivity to the active substance (febuxostat) or to one of the excipients,
- Renal failure defined by creatinine clearance <30 ml / min,
- Hepatic disease defined by an increase to more than 2 times the normal of transaminases, alkaline phosphatases, to more than 3 times the normal of gamma-GT,
- Non-weaned alcoholism,
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- Crisis more than 5 days old,
- Patient who has received an organ or marrow transplant,
- Person on Naproxen, mercaptopurine, azathioprine, Glycuronidation inhibitors and inducers, theophylline, macrolides, HMG Co-A reductase inhibitors and / or diuretic in combination with an ACE inhibitor or ARAII,
- Person with rare hereditary disorders of galactose intolerance, lactase deficiency or glucose / galactose malabsorption
- Poor understanding of the project due to neurological disease or lack of French practice,
- Pregnant woman or likely to be in the absence of effective contraception (Women of childbearing age should have a negative urine pregnancy test),
- Breastfeeding woman
- Any history of pre-existing major cardiovascular disease (myocardial infarction, stroke, unstable angina, etc.), metabolic, endocrine, psychiatric or cancerous in uncontrolled development,
- Person deprived of liberty by an administrative or judicial decision,
- Person placed under judicial protection, guardianship or curatorship,
- Participating patient who participated in the month preceding inclusion in another interventional drug trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Caen
Caen
Centre Hospitalier Public du Cotentin
Cherbourg
CHG Dieppe
Dieppe
CHI Elbeuf, Louvier, Val de Reuil
Elbeuf
GH Le Havre
Le Havre
CHU de Rouen
Rouen
About this study
Official title: Non-inferiority Study of a New Therapeutic Strategy for Gout: Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration - FEFACRIGOU Trial
Gout, the most common inflammatory rheumatism in France, is a complication of chronic hyperuricemia (> 360umol / l). The resulting urate crystals are deposited in many tissues, especially the skeletal or kidneys. It appears in the form of spontaneously regressive inflammatory joint attacks in 5 to 7 days but recurrent. Gout turns into a chronic disease if uric acidemia is not reduced, and is responsible for joint destruction. It becomes a vector of renal failure and is associated with cardiovascular morbidity and a reduction in life expectancy. It is cured if a long-term treatment such as febuxostat leading to the normalization of the uric acidemia is administered.
However, the frequency of this disease is increasing in industrialized or emerging countries. The causes are numerous, particularly food, but also related to flaws in therapeutic care. Studies show that this treatment is not taken in particular because, after the acute attack, the patient who has become asymptomatic again no longer consults. Currently, in a traditional way and according to European recommendations, it is not prescribed until several weeks after the acute attack in order to avoid early relapses, which would then be more numerous. Nevertheless, even if the hypouricemic agent is prescribed late , the attacks can be repeated and become rare for several months after obtaining a uricemia below 360umol / l; they eventually disappear. Lack of knowledge of this disease largely affects the hazards of disease-modifying treatment, which alone can prevent the progression to chronic inflammatory disease and its cardiovascular and renal impact and on mortality. One of the causes of not taking a hypouricemic agent is its delayed administration.
This study is proposed to assess the relevance of early initiation versus delayed administration of such treatment.
Read the detailed description
This is a non-inferiority study comparing immediate administration with 6 weeks delayed administration of febuxostat at a dose of 80 mg / day. The methodology of non-inferiority is what we want to show. Indeed, the immediate initiation of a hypo-uricemic agent is currently considered as an aggravating factor with respect to the duration or the risks of early relapse of the crisis, without this being supported by precise studies. The basic treatment is beneficial in the long term: by normalizing uricemia, it controls gouty disease. We want to show that the early introduction is as well tolerated as its abstention which is the current recommendation.
The diagnosis of gout attack is based on recently established American-European criteria.
The choice of the hyporuricemic molecule is febuxostat, on the one hand because of a greater potency of action than allopurinol at the available dosages, which should make it possible to obtain a clear reduction in uraemia (of approximately 40%) and on the other hand easy to use - without dose adjustment - in patients with renal insufficiency with a creatinine clearance greater than 30 ml / min.
The number of patients participating in the study is set at 128, which is higher than the published prospective studies. Patients will be randomized (in order of succession when entering the study) into 2 groups, the first receiving febuxostat immediately for 6 weeks, the second receiving no immediate febuxostat treatment - which corresponds to current practice.
This study covers several periods:
- the first, lasting 6 weeks, will allow a direct comparison of febuxostat with no DMARD: this is the primary objective.
- the second is an extension phase and runs from the 7th to the 12th week where each patient in the context of routine care is treated with febuxostat: it makes it possible to compare the immediate use of the febuxostat (phase S0-S1 of the group 1) to its delayed administration (phase S6-S12 of group 2 with delayed administration) in terms of recurrence of gouty attacks.
- the 3 ° of 3 months allows a later evaluation at 6 months of therapeutic maintenance.
The evaluations will take place at the end of the 2nd and 6th week (plus or minus 3 days) and at the end of the 3rd and 6th month (plus or minus one week).
They are carried out by an assessor who does not know the treatment of the patient.
They are based on the following parameters:
1- The number of days with gouty joint crisis, its location, reported by the patient in a booklet filled out daily: the occurrence of a new attack according to the criteria evaluated will also be collected.
2 - Assessment by the patient of his condition (pain, asthenia, walking, overall condition) by daily use of the VAS scale. Two functional indexes will be used and have been evaluated in gout -: the SF 36 Physical Dimension is filled during the 6 ° and 12 ° week visits: this index was chosen because it was not specific for a joint disease. and evaluate a period of 4 weeks; HAQ, developed for rheumatoid arthritis, evaluates a period of 2 weeks and provides a correct estimate of overall physical function (locomotor status) in tophaceae gout, less in the absence of tophus.
3 - Assessment by the doctor of the patient's clinical condition: joint and somatic examination: arthritis (yes or no), presence of tophi, arterial pressure, cardiovascular and skin examination.
4 - Collection of drug intolerances. 5 - At W6 and W12, biological examinations will be carried out, according to the recommendations: determination of uricemia, serum creatinine, transaminases, CRP and determination of the CBC-platelets which makes it possible to control the intake and the biological tolerance of the hypouricemic treatment, the level of biological inflammation.
The treatment of the crisis will respond to European recommendations and will be left to the doctor's free initiative. This treatment will be immediately followed by a preventive treatment for relapse at the recommended doses.
Febuxostat:
Its indication will not refer to European recommendations but to French recommendations: hypo-uricemic treatment is indicated as soon as the diagnosis of gout is retained. It will be delivered at the same time as the treatment of the crisis, within 5 days maximum following its diagnosis.
- Conditions
- Gout
- Being tested
- Adenuric
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenuricDrug
Immediate prescription (at randomization) of ADENURIC 80 mg / day (febuxostat), hypo-uricemic treatment, for a period of 2 x 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Immediate prescription (at randomization) of ADENURIC 80 mg / day (febuxostat), urate-lowering treatment, for a period of 2 x 6 weeks. Receives: Drug: Adenuric |
| Standard care arm | No intervention | Prescription deferred to 6 weeks (42 days +/- 3 days) of ADENURIC 80 mg / day (febuxostat): hypouricemic treatment, for a period of 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the number of days with gout at 42 days +/- 3 days (W6) in patients with an early administration of febuxostat from the acute attack compared to patients with a delayed administration of febuxostat by 6 weeks after the acute attack.
number of days with gout at 42 days (S6) assessed by the daily booklet given to the patient, allowing him to inform daily whether he has suffered from gout or not
Measured: 6 weeks
Secondary outcomes (3)
To compare, in patients with early administration of febuxostat compared to patients with delayed administration the function of the patient during the study (until 26 weeks)
Physicians Global Assessment to measure quality of life
Measured: During the study (from the randomisation to 26 weeks)
To compare, in patients with early administration of febuxostat compared to patients with delayed administration the intensity of pain during the study (until 26 weeks)
Visual Analog Score for pain
Measured: During the study (from the randomisation to 26 weeks)
To compare, in patients with early administration of febuxostat compared to patients with delayed administration the tolerance of treatment during the study (until 26 weeks)
Number of adverse events
Measured: During the study (from the randomisation to 26 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start2 Aug 2023
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
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 University Hospital, RouenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109936
- Sponsor's protocol ID
- 2017/386/HP
- Acronym
- FEFACRIGOU
- Status last verified
- Nov 2026
- First submitted
- 27 Sep 2021
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study of a New Therapeutic Strategy for Gout: Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration - FEFACRIGOU Trial
- ClinicalTrials.gov ID
- NCT05109936
- Acronym / sponsor ID
- FEFACRIGOU / 2017/386/HP
- Conditions
- Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 5 Nov 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, the most common inflammatory rheumatism in France, is a complication of chronic hyperuricemia (> 360umol / l). The resulting urate crystals are deposited in many tissues, especially the skeletal or kidneys. It appears in the form of spontaneously regressive inflammatory joint attacks in 5 to 7 days but recurrent. Gout turns into a chronic disease if uric acidemia is not reduced, and is responsible for joint destruction. It becomes a vector of renal failure and is associated with cardiovascular morbidity and a reduction in life expectancy. It is cured if a long-term treatment such as febuxostat leading to the normalization of the uric acidemia is administered.
However, the frequency of this disease is increasing in industrialized or emerging countries. The causes are numerous, particularly food, but also related to flaws in therapeutic care. Studies show that this treatment is not taken in particular because, after the acute attack, the patient who has become asymptomatic again no longer consults. Currently, in a traditional way and according to European recommendations, it is not prescribed until several weeks after the acute attack in order to avoid early relapses, which would then be more numerous. Nevertheless, even if the hypouricemic agent is prescribed late , the attacks can be repeated and become rare for several months after obtaining a uricemia below 360umol / l; they eventually disappear. Lack of knowledge of this disease largely affects the hazards of disease-modifying treatment, which alone can prevent the progression to chronic inflammatory disease and its cardiovascular and renal impact and on mortality. One of the causes of not taking a hypouricemic agent is its delayed administration.
This study is proposed to assess the relevance of early initiation versus delayed administration of such treatment.
Detailed description
This is a non-inferiority study comparing immediate administration with 6 weeks delayed administration of febuxostat at a dose of 80 mg / day. The methodology of non-inferiority is what we want to show. Indeed, the immediate initiation of a hypo-uricemic agent is currently considered as an aggravating factor with respect to the duration or the risks of early relapse of the crisis, without this being supported by precise studies. The basic treatment is beneficial in the long term: by normalizing uricemia, it controls gouty disease. We want to show that the early introduction is as well tolerated as its abstention which is the current recommendation.
The diagnosis of gout attack is based on recently established American-European criteria.
The choice of the hyporuricemic molecule is febuxostat, on the one hand because of a greater potency of action than allopurinol at the available dosages, which should make it possible to obtain a clear reduction in uraemia (of approximately 40%) and on the other hand easy to use - without dose adjustment - in patients with renal insufficiency with a creatinine clearance greater than 30 ml / min.
The number of patients participating in the study is set at 128, which is higher than the published prospective studies. Patients will be randomized (in order of succession when entering the study) into 2 groups, the first receiving febuxostat immediately for 6 weeks, the second receiving no immediate febuxostat treatment - which corresponds to current practice.
This study covers several periods:
- the first, lasting 6 weeks, will allow a direct comparison of febuxostat with no DMARD: this is the primary objective.
- the second is an extension phase and runs from the 7th to the 12th week where each patient in the context of routine care is treated with febuxostat: it makes it possible to compare the immediate use of the febuxostat (phase S0-S1 of the group 1) to its delayed administration (phase S6-S12 of group 2 with delayed administration) in terms of recurrence of gouty attacks.
- the 3 ° of 3 months allows a later evaluation at 6 months of therapeutic maintenance.
The evaluations will take place at the end of the 2nd and 6th week (plus or minus 3 days) and at the end of the 3rd and 6th month (plus or minus one week).
They are carried out by an assessor who does not know the treatment of the patient.
They are based on the following parameters:
1- The number of days with gouty joint crisis, its location, reported by the patient in a booklet filled out daily: the occurrence of a new attack according to the criteria evaluated will also be collected.
2 - Assessment by the patient of his condition (pain, asthenia, walking, overall condition) by daily use of the VAS scale. Two functional indexes will be used and have been evaluated in gout -: the SF 36 Physical Dimension is filled during the 6 ° and 12 ° week visits: this index was chosen because it was not specific for a joint disease. and evaluate a period of 4 weeks; HAQ, developed for rheumatoid arthritis, evaluates a period of 2 weeks and provides a correct estimate of overall physical function (locomotor status) in tophaceae gout, less in the absence of tophus.
3 - Assessment by the doctor of the patient's clinical condition: joint and somatic examination: arthritis (yes or no), presence of tophi, arterial pressure, cardiovascular and skin examination.
4 - Collection of drug intolerances. 5 - At W6 and W12, biological examinations will be carried out, according to the recommendations: determination of uricemia, serum creatinine, transaminases, CRP and determination of the CBC-platelets which makes it possible to control the intake and the biological tolerance of the hypouricemic treatment, the level of biological inflammation.
The treatment of the crisis will respond to European recommendations and will be left to the doctor's free initiative. This treatment will be immediately followed by a preventive treatment for relapse at the recommended doses.
Febuxostat:
Its indication will not refer to European recommendations but to French recommendations: hypo-uricemic treatment is indicated as soon as the diagnosis of gout is retained. It will be delivered at the same time as the treatment of the crisis, within 5 days maximum following its diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: AdenuricImmediate prescription (at randomization) of ADENURIC 80 mg / day (febuxostat), urate-lowering treatment, for a period of 2 x 6 weeks. |
| Standard care arm | No intervention | –Prescription deferred to 6 weeks (42 days +/- 3 days) of ADENURIC 80 mg / day (febuxostat): hypouricemic treatment, for a period of 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with an attack of gout, diagnosed immediately or less than 5 days old. Gout is defined according to American-European criteria (Appendix 3).
- Attack of gout affecting one (or more) peripheral joint (s) whatever (s) it (s):
- Uricemia ≥ 420 µmol / l, including under a diuretic (dosage carried out within 10 days before inclusion),
- Age ≥ 18 years old,
- Patient with a creatinine clearance ≥ 30 ml / min (dosage carried out within 10 days before inclusion),
Key exclusion criteria (17 listed)
- Patients under the age of 18,
- Stop taking a hypouricemic agent for less than 6 months,
- Known contraindication to ADENURIC 80 mg film-coated tablet: hypersensitivity to the active substance (febuxostat) or to one of the excipients,
- Renal failure defined by creatinine clearance <30 ml / min,
- Hepatic disease defined by an increase to more than 2 times the normal of transaminases, alkaline phosphatases, to more than 3 times the normal of gamma-GT,
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 |
|---|---|---|
| AdenuricImmediate prescription (at randomization) of ADENURIC 80 mg / day (febuxostat), hypo-uricemic treatment, for a period of 2 x 6 weeks | Drug | Experimental arm |
Primary outcome
To compare the number of days with gout at 42 days +/- 3 days (W6) in patients with an early administration of febuxostat from the acute attack compared to patients with a delayed administration of febuxostat by 6 weeks after the acute attack.
Time frame: 6 weeks
number of days with gout at 42 days (S6) assessed by the daily booklet given to the patient, allowing him to inform daily whether he has suffered from gout or not
3 secondary outcomes
To compare, in patients with early administration of febuxostat compared to patients with delayed administration the function of the patient during the study (until 26 weeks)
Time frame: During the study (from the randomisation to 26 weeks)
To compare, in patients with early administration of febuxostat compared to patients with delayed administration the intensity of pain during the study (until 26 weeks)
Time frame: During the study (from the randomisation to 26 weeks)
To compare, in patients with early administration of febuxostat compared to patients with delayed administration the tolerance of treatment during the study (until 26 weeks)
Time frame: During the study (from the randomisation to 26 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adenuric in people with Gout, run by University Hospital, Rouen at 6 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 10 inclusion and 17 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: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the number of days with gout at 42 days +/- 3 days (W6) in patients with an early administration of febuxostat from the acute attack compared to patients with a delayed administration of febuxostat by 6 weeks after the acute attack. (time frame: 6 weeks). 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 6 Nov 2026.