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

Who is this study for? Patients with gout
What treatments are being studied? Adenuric
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 Where Postmenopausal woman: amenorrhea not medically induced for at least 12 months before the inclusion visit.

Locations
Other Locations
France
CHU de Caen
RECRUITING
Caen
Centre Hospitalier Public du Cotentin
RECRUITING
Cherbourg
CHG Dieppe
RECRUITING
Dieppe
CHI Elbeuf, Louvier, Val de Reuil
RECRUITING
Elbeuf
GH Le Havre
RECRUITING
Le Havre
CHU de Rouen
RECRUITING
Rouen
Contact Information
Primary
David MALLET
secretariat.DRC@chu-rouen.fr
0033232888265
Time Frame
Start Date: 2023-08-02
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 128
Treatments
Experimental: Experimental arm
Immediate prescription (at randomization) of ADENURIC 80 mg / day (febuxostat), urate-lowering treatment, for a period of 2 x 6 weeks.
No_intervention: Standard care arm
Prescription deferred to 6 weeks (42 days +/- 3 days) of ADENURIC 80 mg / day (febuxostat): hypouricemic treatment, for a period of 6 weeks.
Sponsors
Leads: University Hospital, Rouen

This content was sourced from clinicaltrials.gov

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