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

NCT ID: NCT03210610

Last Updated: 2018-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-19

Study Completion Date

2020-07-15

Brief Summary

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

Detailed Description

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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.

Conditions

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FMF Colchicine Resistance Colchicine Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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FMF patients

fmf patients under a constant colchicine dose

colchicine level measurement

Intervention Type DIAGNOSTIC_TEST

levels of colchicine will be measured in FMF patients taking colchicine

Interventions

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colchicine level measurement

levels of colchicine will be measured in FMF patients taking colchicine

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* constant colchicine levels
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Merav Lidar

Director, Head of rheumatology clinic, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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merav lidar, prof

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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merav lidar, prof

Role: CONTACT

+972-3-5304413

Facility Contacts

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merav lidar, prof

Role: primary

+972-3-5304413

Other Identifiers

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3997-17-SMC

Identifier Type: -

Identifier Source: org_study_id

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