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Non-inferiority study of a new therapeutic strategy for gout: immediate prescription of a hypouricemia treatment, febuxostat, compared to its deferred administration. FEFACRIGOU
EU CTIS ID: 2024-515547-34-00
What this study is testing
The primary objective is to compare the number of days with gout at 42 days +/- 3 days (S6) in patients with early administration of febuxostat from the acute attack versus patients with delayed administration of febuxostat by 6 weeks after the acute attack.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- 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
You likely can't join if
- Patients under the age of 18
- 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
- All pre-existing diseases listed below: - Cardiovascular diseases: any manifestation associated with heart failure (exertional dyspnea stage III-IV and BNP correlated with age >=3N and ejection fraction < 40%), unstable angina and/or coronary syndrome or myocardial necrosis less than 1 month old, arteritis of the lower limbs stage 3- 4, uncontrolled hypertension; - Neurological diseases: amyotrophic lateral sclerosis or progressive MS, any dementia syndrome, confusional syndrome, any intellectual disability and recent stroke (less than 4 weeks old); - Endocrine and metabolic diseases: uncontrolled hyperthyroidism, severe untreated hypothyroidism, Cushing's disease, endocrine polyadenomatosis, insulin-dependent or non-decompensated diabetes: ketoacidosis, hyperosmolarity; - Liver diseases: hepatocellular insufficiency (TP < 60, albuminemia < 30 g/l); - Pulmonary diseases: any severe respiratory insufficiency requiring oxygen therapy of any daily duration; any alveolo-interstitial pathology, whether treated or not; - Ongoing cancer or haematological diseases under active treatment, with the exception of hormonal treatments; - Severe psychiatric disorders which have not stabilized and which may interfere with understanding of the protocol, reduce compliance with treatment and have a negative impact on the quality of adverse event data; - Active autoimmune diseases, such as lupus or certain vasculitides, which are prone to multisystemic complications and often require immunosuppressive therapy.
See the full eligibility criteria
Who can 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
- 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.
- Postmenopausal woman: amenorrhea not medically induced for at least 12 months before the inclusion visit.
What rules you out
- Patients under the age of 18
- 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
- All pre-existing diseases listed below: - Cardiovascular diseases: any manifestation associated with heart failure (exertional dyspnea stage III-IV and BNP correlated with age >=3N and ejection fraction < 40%), unstable angina and/or coronary syndrome or myocardial necrosis less than 1 month old, arteritis of the lower limbs stage 3- 4, uncontrolled hypertension; - Neurological diseases: amyotrophic lateral sclerosis or progressive MS, any dementia syndrome, confusional syndrome, any intellectual disability and recent stroke (less than 4 weeks old); - Endocrine and metabolic diseases: uncontrolled hyperthyroidism, severe untreated hypothyroidism, Cushing's disease, endocrine polyadenomatosis, insulin-dependent or non-decompensated diabetes: ketoacidosis, hyperosmolarity; - Liver diseases: hepatocellular insufficiency (TP < 60, albuminemia < 30 g/l); - Pulmonary diseases: any severe respiratory insufficiency requiring oxygen therapy of any daily duration; any alveolo-interstitial pathology, whether treated or not; - Ongoing cancer or haematological diseases under active treatment, with the exception of hormonal treatments; - Severe psychiatric disorders which have not stabilized and which may interfere with understanding of the protocol, reduce compliance with treatment and have a negative impact on the quality of adverse event data; - Active autoimmune diseases, such as lupus or certain vasculitides, which are prone to multisystemic complications and often require immunosuppressive therapy.
- 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
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.