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Search / Trial NCT05418686

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

Familial Mediterranean Fever Colchicin Resistant Drug Compliance Microbiota Drug Resistance Clostrioides Difficile Interleukin 1 Second Line Therapy.

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.

Locations

Paris, , France

Patients applied

0 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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