FMFNCT03210610
Colchicine Levels in the Serum of FMF (Familial Mediterranean Fever) Patients
An observational study of FMF and Colchicine Resistance, run by Sheba Medical Center at 1 site in Israel.
Trial summary
in this study the investigators will measure the colchicine trough levels in 80 FMF patients taking stable doses of colchicine Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- FMF, Colchicine Resistance, Colchicine Toxicity
- What is being tested?
- colchicine level measurement
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Oct 2017to 15 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: FMF patients treated with a constant dose of colchicine
Who may be able to join
- constant colchicine levels
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
merav lidar, prof, +972-3-5304413, merav.lidar@sheba.health.gov.il
About this study
Official title: Measurement of Colchicine Levels in the Serum of FMF Patients
in this study the investigators will measure the colchicine trough levels in 80 FMF patients taking stable doses of colchicine
Read the 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.
- Conditions
- FMF, Colchicine Resistance, Colchicine Toxicity
- Being tested
- colchicine level measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colchicine level measurementDiagnostic test
levels of colchicine will be measured in FMF patients taking colchicine
| Study group | Role | What they receive |
|---|---|---|
| FMF patients | fmf patients under a constant colchicine dose Receives: Diagnostic Test: colchicine level measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
colchicine levels
the trough level of colchicine in the serum
Measured: a single measurement under a constant dosage at visit 1 (time=0, recruitment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start19 Oct 2017
- Primary completion15 Jul 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FMFStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Merav Lidar, Sheba Medical Center
- Investigators
- merav lidar, prof, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210610
- Sponsor's protocol ID
- 3997-17-SMC
- Status last verified
- Apr 2018
- First submitted
- 29 Jun 2017
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Colchicine Levels in the Serum of FMF Patients
- ClinicalTrials.gov ID
- NCT03210610
- Acronym / sponsor ID
- 3997-17-SMC
- Conditions
- FMF, Colchicine Resistance, Colchicine Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMF patients | – | Diagnostic Test: colchicine level measurementfmf patients under a constant colchicine dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- FMF patients treated with a constant dose of colchicine
Key inclusion criteria (1 listed)
- constant colchicine levels
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colchicine level measurementlevels of colchicine will be measured in FMF patients taking colchicine | Diagnostic test | FMF patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for FMF
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
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A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
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Not yet recruitingPhase 3
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
merav lidar, prof principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of FMF and Colchicine Resistance, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact merav lidar, prof (+972-3-5304413, merav.lidar@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
colchicine levels (time frame: a single measurement under a constant dosage at visit 1 (time=0, recruitment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.