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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210610
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Merav Lidar, 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

Condition or disease Intervention/treatment
FMF Colchicine Resistance Colchicine Toxicity Diagnostic Test: colchicine level measurement

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Measurement of Colchicine Levels in the Serum of FMF Patients
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020


Group/Cohort Intervention/treatment
FMF patients
fmf patients under a constant colchicine dose
Diagnostic Test: colchicine level measurement
levels of colchicine will be measured in FMF patients taking colchicine




Primary Outcome Measures :
  1. colchicine levels [ Time Frame: a single measurement under a constant dosage at visit 1 (time=0, recruitment) ]
    the trough level of colchicine in the serum



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
FMF patients treated with a constant dose of colchicine
Criteria

Inclusion Criteria:

  • constant colchicine levels

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210610


Contacts
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Contact: merav lidar, prof +972-3-5304413 merav.lidar@sheba.health.gov.il

Locations
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Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: merav lidar, prof    +972-3-5304413    merav.lidar@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: merav lidar, prof Sheba Medical Center
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Responsible Party: Prof. Merav Lidar, Director, Head of rheumatology clinic, Principal Investigator, Clinical Professor, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03210610    
Other Study ID Numbers: 3997-17-SMC
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents