Status:
COMPLETED
Study of Colchicine Resistance in Familial Mediterranean Fever
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Mediterranean Fever
Colchicine Resistance
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
Five to 10% of familial mediterranean patients are considered colchicine-resistant (i.e. patients with a persistent inflammatory syndrome, despite taking the maximum tolerated dose of colchicine daily...
Detailed Description
Patients meeting the criteria for colchicine resistance will be included in a follow-up visit. * Adherence to colchicine therapy will be assessed by the Girerd questionnaire completed by the patient ...
Eligibility Criteria
Inclusion
- Inclusion Criteria Age ≥ 12 years with no upper age limit -Patients with familial Mediterranean fever (FMF) meeting international criteria for the disease (Livneh criteria) and carrying 2 pathogenic mutations in the MEFV gene.
- Patients considered colchicine-resistant according to EULAR criteria reviewed by an expert consensus:
- Persistence of signs of activity (at least one attack per month for at least 3 months) despite taking the maximum tolerated dosage of colchicine.
- Persistence of a biological inflammatory syndrome after exclusion of other causes and despite taking a maximum tolerated dosage of colchicine.
- Signature of an informed consent by the patient (or his parents if under 18 years of age)
- Patients affiliated to a social security system
Exclusion
- \- Patients participating in another interventional trial
Key Trial Info
Start Date :
December 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05418686
Start Date
December 9 2022
End Date
October 27 2023
Last Update
April 8 2024
Active Locations (1)
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1
Service de Médecine Interne. Hôpital Tenon, 4 Rue de la Chine
Paris, France, 75020