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NCT03210610 Clinical Trial

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

FMF Clinical Trial

Official title:
Measurement of Colchicine Levels in the Serum of FMF Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03210610
Other study ID # 3997-17-SMC
Secondary ID
Status Recruiting
Phase
First received June 29, 2017
Last updated April 18, 2018
Start date October 19, 2017
Est. completion date July 15, 2020

Study information
Verified date April 2018
Source Sheba Medical Center
Contact merav lidar, prof
Phone +972-3-5304413
Email merav.lidar@sheba.health.gov.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date July 15, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- constant colchicine levels

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• colchicine level measurement
levels of colchicine will be measured in FMF patients taking colchicine

Locations
Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary colchicine levels the trough level of colchicine in the serum a single measurement under a constant dosage at visit 1 (time=0, recruitment)
See also
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Recruiting NCT05980780 - The Effect of Video Game on Children With Familial Mediterranean Fever N/A
Completed NCT05398536 - Kinesiophobia in Familial Mediterranean Fever
Not yet recruiting NCT06047938 - FMF and Atheroscelerosis
Recruiting NCT05092776 - 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 Phase 2
Enrolling by invitation NCT04403438 - Familial Mediterranean Fever and Behçet: Analysis Before and After Covid19 Pandemic