Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration

NCT05109936 | Recruiting Phase 3

• 1 other identifier: 2017/0386/HP
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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)

  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)

  During the study (from the randomisation to 26 weeks)

Study Arms (2)

Experimental arm

EXPERIMENTAL

Immediate prescription (at randomization) of ADENURIC 80 mg / day (febuxostat), urate-lowering treatment, for a period of 2 x 6 weeks.

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.

Interventions

Adenuric DRUG

Immediate prescription (at randomization) of ADENURIC 80 mg / day (febuxostat), hypo-uricemic treatment, for a period of 2 x 6 weeks

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• Age ≥ 18 years old,
• Patient having read and understood the information letter and signed the consent form,
• Affiliation to a social security scheme,

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (6)

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

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

David MALLET

CONTACT

0033232888265; secretariat.DRC@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: November 5, 2021
• Study Start: August 2, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)