Understanding colchicine resistance in Familial Mediterranean Fever; exploring pathophysiological mechanisms and therapeutic options

Understanding colchicine resistance in Familial Mediterranean Fever; exploring pathophysiological mechanisms and therapeutic options - CRAFT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56532

Enrollment

100

Registered

2023-08-03

Start date

2024-09-02

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Mediterranian Fever

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria:  Patients: Diagnosis of FMF (genetically confirmed). Insufficient control of  symptoms despite use of colchicine Controls: Diagnosis of FMF (genetically confirmed). In remission on colchicine 

Exclusion criteria

Exclusion criteria:  pregnancy 

Design outcomes

Primary

Measure	Time frame
Within cases and controls we will determine intracellular levels of colchicine, assuming that cases will have lower intracellular colchicine levels as compared to controls. Additionally, we will perform genomics analysis on peripheral blood cells as well as transcriptomic analysis by single cell RNA-seq in order to identify potential differences in genetic profile and gene expression between cases and controls.	—

Measure

Time frame

Within cases and controls we will determine intracellular levels of colchicine, assuming that cases will have lower intracellular colchicine levels as compared to controls. Additionally, we will perform genomics analysis on peripheral blood cells as well as transcriptomic analysis by single cell RNA-seq in order to identify potential differences in genetic profile and gene expression between cases and controls.

—

Secondary

Measure	Time frame
Are demographic factors like age, gender and body composition associated with colchicine response?	—

Countries

Netherlands

Contacts

Public ContactP.L.A. Daele

Erasmus MC, Universitair Medisch Centrum Rotterdam

p.l.a.vandaele@erasmusmc.nl0636178953

Outcome results