Study of Colchicine Resistance in Familial Mediterranean Fever
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 10, 2022
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
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 at the inclusion visit.
* A blood test is performed including a haemogram, CRP and SAA, creatinine and proteinuria.
* a standard stool analysis on site to look for C. difficile toxin.
For research purposes, samples of:
* Stool.
* A strand of hair with the diameter of a pencil and a minimum length of 2 cm, in the region of the posterior vertex, where the growth and integration are relatively c...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • - Patients participating in another interventional trial
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Patients applied
Trial Officials
Léa SAVEY, MD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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