Colchicine Levels in the Serum of FMF (Familial Mediterranean Fever) Patients

• Conditions: FMF; Colchicine Resistance; Colchicine Toxicity
• Interventions: Diagnostic Test: colchicine level measurement

• Registration Number: NCT03210610
• Lead Sponsor: Sheba Medical Center

Brief Summary

in this study the investigators will measure the colchicine trough levels in 80 FMF patients taking stable doses of colchicine

Detailed Description

80 FMF patients will enroll: 20 taking 1 mg colchicine a day 20 taking 1.5 mg colchicine a day 20 taking 2 mg colchicine a day 20 taking 2.5 mg colchicine a day one blood sample for trough colchicine levels will be taken. response to treatment, colchicine side effects and anthropometric data will be collected.

Study Timeline

• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-07
• Study Start: 2017-10-19
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• constant colchicine levels

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FMF patients	colchicine level measurement	fmf patients under a constant colchicine dose

Primary Outcome Measures

Name	Time	Method
colchicine levels	a single measurement under a constant dosage at visit 1 (time=0, recruitment)	the trough level of colchicine in the serum

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel