Immediate versus delayed febuxostat treatment for gout

Non-inferiority Study of a New Therapeutic Strategy for Gout: Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration - FEFACRIGOU Trial

This trial will test whether starting febuxostat right away instead of waiting 6 weeks is as safe and effective for adults having a gout attack.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Locations: 6 sites (Caen and 5 other locations)
• Trial ID: NCT05109936 on ClinicalTrials.gov

What this trial studies

This is a randomized, phase 3 non-inferiority trial comparing immediate initiation of febuxostat 80 mg/day to delayed initiation after 6 weeks in adults presenting with an acute gout attack. A total of 128 participants with confirmed gout and uricemia ≥ 420 µmol/L will be randomized to receive either immediate febuxostat for 6 weeks or no immediate febuxostat according to current recommendations. Key inclusion requirements include age ≥ 18, gout attack onset within 5 days, and creatinine clearance ≥ 30 mL/min; randomization is by order of entry. The primary focus is to show that early introduction of febuxostat is as well tolerated as delayed introduction without increasing early relapse risk while producing rapid urate reduction.

Who should consider this trial

Good fit: Adults (≥18 years) with a recent gout attack (onset ≤5 days), serum uric acid ≥420 µmol/L, creatinine clearance ≥30 mL/min, not currently on urate-lowering therapy or off it for ≥6 months, and willing to provide informed consent are ideal candidates.

Not a fit: Patients with creatinine clearance <30 mL/min, serum uric acid below 420 µmol/L, those already on continuous urate-lowering therapy, or unable to attend participating French sites are unlikely to benefit from joining this trial.

Why it matters

Potential benefit: If successful, patients could safely begin febuxostat during an acute gout attack, achieving earlier uric acid control and potentially reducing future flares and joint damage.

How similar studies have performed: Febuxostat is already established as an effective urate-lowering drug, but randomized data specifically testing immediate initiation during an acute gout attack are limited, making this approach relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients with an attack of gout, diagnosed immediately or less than 5 days old. Gout is defined according to American-European criteria (Appendix 3).
2. 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.
3. Uricemia ≥ 420 µmol / l, including under a diuretic (dosage carried out within 10 days before inclusion),
4. Age ≥ 18 years old,
5. Patient with a creatinine clearance ≥ 30 ml / min (dosage carried out within 10 days before inclusion),
6. Patient having read and understood the information letter and signed the consent form,
7. Affiliation to a social security scheme,
8. 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.

Exclusion Criteria:

1. Patients under the age of 18,
2. Stop taking a hypouricemic agent for less than 6 months,
3. Known contraindication to ADENURIC 80 mg film-coated tablet: hypersensitivity to the active substance (febuxostat) or to one of the excipients,
4. Renal failure defined by creatinine clearance \<30 ml / min,
5. 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,
6. Non-weaned alcoholism,
7. Crisis more than 5 days old,
8. Patient who has received an organ or marrow transplant,
9. 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,
10. Person with rare hereditary disorders of galactose intolerance, lactase deficiency or glucose / galactose malabsorption
11. Poor understanding of the project due to neurological disease or lack of French practice,
12. Pregnant woman or likely to be in the absence of effective contraception (Women of childbearing age should have a negative urine pregnancy test),
13. Breastfeeding woman
14. Any history of pre-existing major cardiovascular disease (myocardial infarction, stroke, unstable angina, etc.), metabolic, endocrine, psychiatric or cancerous in uncontrolled development,
15. Person deprived of liberty by an administrative or judicial decision,
16. Person placed under judicial protection, guardianship or curatorship,
17. Participating patient who participated in the month preceding inclusion in another interventional drug trial.

Where this trial is running

Caen and 5 other locations

• CHU de Caen — Caen, France (Recruiting)
• Centre Hospitalier Public du Cotentin — Cherbourg, France (Recruiting)
• CHG Dieppe — Dieppe, France (Recruiting)
• CHI Elbeuf, Louvier, Val de Reuil — Elbeuf, France (Recruiting)
• GH Le Havre — Le Havre, France (Recruiting)
• CHU de Rouen — Rouen, France (Recruiting)

Study contacts

• Study coordinator: David MALLET

Conditions Gout