An interventional study of Capillary colchicine dosage in colchicine-resistant Familial Mediterranean Fever patients. in Mediterranean Fever and Colchicine Resistance, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-04-08.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
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). The recommended treatment in this case is a subcutaneous anti-interleukin 1 biotherapy (anakinra or canakinumab). These treatments are expensive (1,000 to 12,000 euros/month).
However, for a patient to be considered colchicine-resistant, compliance with the treatment must be verified. Furthermore specific activation of the pyrin inflammasome by Clostrioides difficile toxin and the overrepresentation of these bacteria in the stools of our patients led us to systematically search for them in our resistant patients. The demonstration of the involvement of C. difficile in the imbalance of the disease has not yet been published.
The colchiresist study aim to better characterize colchicine-resistance by confirming good compliance to treatment with colchicine hair measurement and by looking for clostrioides infection or intestinal dysbiosis.
Patients meeting the criteria for colchicine resistance will be included in a follow-up visit.
For research purposes, samples of:
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:
Exclusion Criteria:
Biological: Capillary colchicine dosage in colchicine-resistant Familial Mediterranean Fever patients.
* Adherence to colchicine therapy will be assessed by the Girerd questionnaire (6 questions ) completed by the patient at the inclusion visit. * A blood sample (8ml) is taken, including a haemogram, CRP and creatinine and proteinuria. * Standard on-site stool analysis for C. difficile toxin. For research purposes, samples of: * Stool. If the patient is unable to produce stools on the day of the visit, a collection kit with 2 tubes containing a preservative will be given to him/her as well as a stamped envelope to take the sample at home and send it by post within 10 days according to a validated procedure. * A strand of hair with the diameter of a pencil and a minimum length of 2 cm, in the region of the posterior vertex. * In patients with baldness or bleached hair only: pubic and/or axillary hair, a pencil-sized strand. * Additional blood (5ml) and urine (2ml) samples for colchicine determination.
Amount of colchicine measured in the first 2 cm of hair from the scalp of an FMF patient considered colchicine resistant or from pubic hair in patients with bald or colored hair, which corresponds to the average compliance of the last 2 months of intake
To assess 2-month compliance with colchicine in patients with FMF considered resistant via capillary drug dosage
Time frame: Through study completion, an average of 18 months
Correlation between the amount of colchicine measured in the hair and the blood and urine levels of colchicine attesting to the last days' intake.
To study blood and urine colchicine dosage in FMF patients considered resistant to colchicine
Time frame: Through study completion, an average of 18 months
Correlation between capillary colchicine dosage and colchicine compliance assessed with the 6-item GIRERD
Compare hair dosing to self-reported compliance
Time frame: Through study completion, an average of 18 months
Composition of the fecal microbiota (search for an overrepresentation of clostridiae) in colchicine-resistant patients patients with colchicine resistance
Studying the composition of the fecal microbiota in colchicine-resistant FMF patients
Time frame: Through study completion, an average of 18 months
Testing for clostridioides difficile toxin B in colchicin-resistant patients
Testing colchicine-resistant FMF patients for clostridioides difficile toxin to rule out chronic asymptomatic carriage
Time frame: Through study completion, an average of 18 months
Dosage of proinflammatory cytokines IL1, IL6, IL18, TNFa and il1Ra.
Study blood levels of proinflammatory cytokines in colchicine-resistant patients, in particular IL1 and il1RA
Time frame: Through study completion, an average of 18 months
Percentage of patients for whom a prescription of anti-IL-1 biotherapy could have been avoided (i.e. poor compliance with Colchicine and/or Clostrioides Difficile infection)
Determine the percentage of patients labeled colchicine resistant who were actually noncompliant or chronically infected with pyrin-activating bacteria like clostridioides difficile
Time frame: Through study completion, an average of 18 months
Plan to share: No
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Assistance Publique - Hôpitaux de Paris