Non-inferiority study of a new therapeutic strategy for gout: immediate prescription of a hypouricemia treatment, febuxostat, compared to its deferred administration. FEFACRIGOU

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Rouen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

12 Aug 2025 → ongoing

Decision date (initial)

2024-07-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-515547-34-00

EudraCT number

2020-004766-19

ClinicalTrials.gov

NCT05109936

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

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.

Secondary objectives 5

1. Pain intensity at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days,
2. Patient function at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days
3. Treatment tolerance at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days
4. Occurrence of one or more new gout attacks at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days
5. Number of days with gout at 14 (S2), 84 (S12) and 182 (S26) days

Conditions and MedDRA coding

The gout

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

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

Exclusion criteria 17

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. 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.
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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint was the number of days with gout at 42 days (S6), as assessed by the daily logbook (Appendix 7) given to the patient, enabling him to record daily whether or not he had suffered from gout

Secondary endpoints 5

1. Pain measured by the EVA centimetric scale at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days
2. HAQ questionnaire score (Appendix 6) at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, SF36 questionnaire score (Appendix 5) at 42 (S6), 84 (S12) and 182 (S26) days and walking perimeter at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days for patient function
3. Treatment tolerance assessed by the number of adverse events at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days
4. Number of relapses, with crisis defined by assessed criteria (34) (Appendix 4) at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days
5. The number of days with gout, assessed using the daily logbook (Appendix 7) given to the patient, which enables him or her to indicate whether or not he or she has suffered from gout on 14 (S2), 84 (S12) and 182 (S26) days

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Rouen

Sponsor organisation

Centre Hospitalier Universitaire Rouen

Address

1 Rue De Germont, Bp 96031 Bp 96031

City

Rouen Cedex

Postcode

76031

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

MALLET David

Public contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

MALLET David

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 2 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications