Study of Colchicine Resistance in Familial Mediterranean Fever

Related Clinical Trial
Study of Colchicine Resistance in Familial Mediterranean Fever Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever Central Sensitization in Familial Mediterranean Fever (FMF) Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever Characterization of a Functional Test for Mediterranean Family Fever Screening – 2 Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis Heat Intolerance in the Group of FMF Patients Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMF Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission Tocilizumab for the Treatment of Familial Mediterranean Fever Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever. A Diagnostic Test for Familial Mediterranean Fever Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever Rilonacept for Treatment of Familial Mediterranean Fever (FMF)

Brief Title

Study of Colchicine Resistance in Familial Mediterranean Fever

Official Title

Study Of Colchicine Resistance In Familial Mediterranean Fever

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). 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.

Detailed Description

      Patients meeting the criteria for colchicine resistance will be included in a follow-up

        -  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

        -  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 constant
           to avoid variability.

        -  In patients with baldness or bleached hair only: pubic and/or axillary hair will be
           taken, The samples will then be processed without segmentation.

        -  Additional blood (5ml) and urine (2ml) samples for colchicine dosage. The patient's
           participation ends after this visit

Study Type


Primary Outcome

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

Secondary Outcome

 Correlation between the amount of colchicine measured in the hair and the blood and urine levels of colchicine attesting to the last days' intake.


Mediterranean Fever


Capillary colchicine dosage in colchicine-resistant Familial Mediterranean Fever patients.

Study Arms / Comparison Groups

 Colchicine-resistant Familial Mediterranean Fever patients


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

July 2022

Completion Date

January 2024

Primary Completion Date

January 2024

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

          -  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

          -  Patients affiliated to a social security system

        Exclusion Criteria:

        - Patients participating in another interventional trial




12 Years - N/A

Accepts Healthy Volunteers



Léa SAVEY, MD, 0033156017431, [email protected]

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Assistance Publique - Hôpitaux de Paris

Study Sponsor

Léa SAVEY, MD, Principal Investigator, Assistance Publique - Hôpitaux de Paris

Verification Date

June 2022