Actively Recruiting
Non-inferiority Study of Immediate versus Delayed Febuxostat Treatment for Gout - FEFACRIGOU Trial
Led by University Hospital, Rouen · Updated on 2026-06-08
128
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Gout is a common inflammatory condition caused by high levels of uric acid leading to painful joint attacks and potentially chronic joint damage, kidney failure, and cardiovascular problems. This trial investigates whether starting febuxostat, a urate-lowering medication, immediately after an acute gout attack is as safe and effective as the current practice of delaying treatment by six weeks. The study aims to better understand if early treatment can prevent worsening of gout and its complications without increasing early relapses. Participants are randomly assigned to one of two groups one begins febuxostat treatment immediately at 80 mg daily for 12 weeks, and the other starts febuxostat only after a six-week delay. The study includes an initial 6-week comparison period, followed by an extension phase where all participants receive febuxostat, and a final evaluation at six months to assess ongoing treatment effects. Febuxostat is chosen for its potency and suitability for patients with moderate kidney issues. Throughout the study, participants will report daily gout symptoms and pain levels using a diary and visual scales. Physical and joint examinations, blood tests to monitor uric acid and inflammation, and assessments of physical function will occur at 2, 6, 12, and 26 weeks. Researchers will track the number of days with gout attacks, treatment tolerance, and overall patient well-being to compare early versus delayed febuxostat use. The study is conducted with blinded evaluators to ensure unbiased results.
CONDITIONS
Brief Title
Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a gout attack diagnosed immediately or less than 5 days old using American-European criteria
- Gout attack affecting one or more peripheral joints
- Either first gout attack or new attack without hypouricemic treatment for at least 6 months
- Uricemia equal to or above 420 �B5mol/L, including under diuretics
- Age 18 years or older
- Creatinine clearance equal to or above 30 ml/min
- Signed informed consent after understanding the study
- Affiliated with a social security scheme
- Women of childbearing potential must use effective contraception and have negative pregnancy tests; postmenopausal women must have 12 months amenorrhea
You will not qualify if you...
- Under 18 years of age
- Taken hypouricemic treatment within the past 6 months
- Known allergy or hypersensitivity to febuxostat or excipients
- Renal failure with creatinine clearance below 30 ml/min
- Liver disease with elevated liver enzymes beyond specified limits
- Active alcoholism not stopped
- Gout attack older than 5 days
- History of organ or marrow transplant
- Taking certain medications including naproxen, mercaptopurine, azathioprine, theophylline, macrolides, statins, or specific drug combinations
- Rare hereditary disorders affecting sugar metabolism
- Poor understanding due to neurological disease or language barrier
- Pregnant or breastfeeding women or women without effective contraception
- History of major uncontrolled cardiovascular, metabolic, endocrine, psychiatric disorders, or active cancer
- Legal restrictions such as imprisonment or guardianship
- Participated in another interventional drug trial within the past month
Research Team
D
David MALLET
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