NCT03210610

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 19, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

2.7 years

First QC Date

June 29, 2017

Last Update Submit

April 18, 2018

Conditions

FMFColchicine ResistanceColchicine Toxicity

Outcome Measures

Primary Outcomes (1)

  • colchicine levels

    the trough level of colchicine in the serum

    a single measurement under a constant dosage at visit 1 (time=0, recruitment)

Study Arms (1)

FMF patients

fmf patients under a constant colchicine dose

Diagnostic Test: colchicine level measurement

Interventions

colchicine level measurementDIAGNOSTIC_TEST

levels of colchicine will be measured in FMF patients taking colchicine

FMF patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

FMF patients treated with a constant dose of colchicine

You may qualify if:

  • constant colchicine levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Study Officials

  • merav lidar, prof

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

merav lidar, prof

CONTACT

+972-3-5304413merav.lidar@sheba.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of rheumatology clinic, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 7, 2017

Study Start

October 19, 2017

Primary Completion

July 15, 2020

Study Completion

July 15, 2020

Last Updated

April 20, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)