Familial Mediterranean FeverNCT00658060
Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients
An observational study of Familial Mediterranean Fever, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Familial Mediterranean fever (FMF) is an inherited disorder of unknown etiology, characterized by recurrent episodes of fever, peritonitis and/or pleuritis. Fever is the cardinal manifestation of FMF and is present in most attacks accompanied by abdominal pain. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Familial Mediterranean Fever
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to not given
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with FMF, fulfilling the Tel Hashomer criteria for the diagnosis of FMF, suffering from episodes of exertional leg pain and or exertional ankle edema, 18-45 years old, on a stable (≥ 2 weeks) dose of oral colchicine therapy, Non-smokers
Who may be able to join
- Fulfilling the Tel Hashomer criteria for the diagnosis of FMF [5].
- Suffering from episodes of exertional leg pain and or exertional ankle edema
- 18-45 years old
- On a stable (≥ 2 weeks) dose of oral colchicine therapy
- Non-smokers
Who cannot join
- with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia)
- Suffering from muscular or neurological diseases not related to FMF
- With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels.
- Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
Iris Eshed
About this study
Official title: Exertional Muscle Fatigue In FMF Patients Evaluated By MRI And MR Spectroscopy Of The Thigh
Familial Mediterranean fever (FMF) is an inherited disorder of unknown etiology, characterized by recurrent episodes of fever, peritonitis and/or pleuritis.
Fever is the cardinal manifestation of FMF and is present in most attacks accompanied by abdominal pain.
Read more
Another clinical manifestation in patients with FMF is exertional muscle pain, usually in the thigh, which appears even after minor exercise or physical activity in young patients with generally good health (other than FMF) and in good physical condition. Some patients also complain of ankle edema after relatively minor physical activity, which subsides after a night rest. Although these manifestations are quite common in FMF patients and form part of the minor criteria for the diagnosis, the etiopathogenesis has not been examined.
The purpose of the suggested study is to evaluate and characterize the anatomical and biochemical changes in the muscles of the thigh and in the ankle triggered by physical activity in FMF patients complaining of exertional lower leg myalgias and edema after minor physical exercise.
- Conditions
- Familial Mediterranean Fever
- Keywords
- FMF, Exertional leg pain
- Medical subject headings
- Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | * 1.Fulfilling the Tel Hashomer criteria for the diagnosis of FMF [5]. * 2.Suffering from episodes of exertional leg pain and or exertional ankle edema * 3.18-45 years old * 4.On a stable (≥ 2 weeks) dose of oral colchicine therapy * 5.Non-smokers | |
| 2 | Control group * 1.Healthy subjects * 2.18-45 years old * 3.Non-smokers |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in spectroscopic appearance of muscle after exertion of muscle thigh
Measured: 1 hour
Secondary outcomes (2)
change in muscle intensity signal after exertion
Measured: 1 hour
change in joint effusion status after exertion
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Familial Mediterranean FeverStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Iris Eshed, MD, Principal investigator, Sheba Medical CenterTammi Kushnir, PhD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658060
- Sponsor's protocol ID
- SHEBA-07-4632-IE-CTIL
- Status last verified
- Apr 2008
- First submitted
- 8 Apr 2008
- Last updated
- 14 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Brik R, Shinawi M, Kasinetz L, Gershoni-Baruch R. The musculoskeletal manifestations of familial Mediterranean fever in children genetically diagnosed with the disease. Arthritis Rheum. 2001 Jun;44(6):1416-9. doi: 10.1002/1529-0131(200106)44:63.0.CO;2-6.
PubMed 11407703Bendahan D, Mattei JP, Guis S, Kozak-Ribbens G, Cozzone PJ. [Non-invasive investigation of muscle function using 31P magnetic resonance spectroscopy and 1H MR imaging]. Rev Neurol (Paris). 2006 Apr;162(4):467-84. doi: 10.1016/s0035-3787(06)75038-x. French.
PubMed 16585908
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exertional Muscle Fatigue In FMF Patients Evaluated By MRI And MR Spectroscopy Of The Thigh
- ClinicalTrials.gov ID
- NCT00658060
- Acronym / sponsor ID
- SHEBA-07-4632-IE-CTIL
- Conditions
- Familial Mediterranean Fever
- Keywords
- FMF, Exertional leg pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2007
- First posted
- 14 Apr 2008 (estimated)
- 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.
Familial Mediterranean fever (FMF) is an inherited disorder of unknown etiology, characterized by recurrent episodes of fever, peritonitis and/or pleuritis.
Fever is the cardinal manifestation of FMF and is present in most attacks accompanied by abdominal pain.
Another clinical manifestation in patients with FMF is exertional muscle pain, usually in the thigh, which appears even after minor exercise or physical activity in young patients with generally good health (other than FMF) and in good physical condition. Some patients also complain of ankle edema after relatively minor physical activity, which subsides after a night rest. Although these manifestations are quite common in FMF patients and form part of the minor criteria for the diagnosis, the etiopathogenesis has not been examined.
The purpose of the suggested study is to evaluate and characterize the anatomical and biochemical changes in the muscles of the thigh and in the ankle triggered by physical activity in FMF patients complaining of exertional lower leg myalgias and edema after minor physical exercise.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –* 1.Fulfilling the Tel Hashomer criteria for the diagnosis of FMF [5]. * 2.Suffering from episodes of exertional leg pain and or exertional ankle edema * 3.18-45 years old * 4.On a stable (≥ 2 weeks) dose of oral colchicine therapy * 5.Non-smokers |
| 2 | – | –Control group * 1.Healthy subjects * 2.18-45 years old * 3.Non-smokers |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with FMF, fulfilling the Tel Hashomer criteria for the diagnosis of FMF, suffering from episodes of exertional leg pain and or exertional ankle edema, 18-45 years old, on a stable (≥ 2 weeks) dose of oral colchicine therapy, Non-smokers
Key inclusion criteria (5 listed)
- Fulfilling the Tel Hashomer criteria for the diagnosis of FMF [5].
- Suffering from episodes of exertional leg pain and or exertional ankle edema
- 18-45 years old
- On a stable (≥ 2 weeks) dose of oral colchicine therapy
- Non-smokers
Key exclusion criteria (4 listed)
- with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia)
- Suffering from muscular or neurological diseases not related to FMF
- With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels.
- Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in spectroscopic appearance of muscle after exertion of muscle thigh
Time frame: 1 hour
2 secondary outcomes
change in muscle intensity signal after exertion
Time frame: 1 hour
change in joint effusion status after exertion
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2008.
- Background: PubMed 11407703Brik R, Shinawi M, Kasinetz L, Gershoni-Baruch R. The musculoskeletal manifestations of familial Mediterranean fever in children genetically diagnosed with the disease. Arthritis Rheum. 2001 Jun;44(6):1416-9. doi: 10.1002/1529-0131(200106)44:63.0.CO;2-6.
- Background: PubMed 16585908Bendahan D, Mattei JP, Guis S, Kozak-Ribbens G, Cozzone PJ. [Non-invasive investigation of muscle function using 31P magnetic resonance spectroscopy and 1H MR imaging]. Rev Neurol (Paris). 2006 Apr;162(4):467-84. doi: 10.1016/s0035-3787(06)75038-x. French.
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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.
Iris Eshed, MD principal investigator
Sheba Medical Center
Tammi Kushnir, PhD 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 Familial Mediterranean Fever, 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 5 inclusion and 4 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 14 Apr 2008. 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, MD (+972-54-4721675, 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?
change in spectroscopic appearance of muscle after exertion of muscle thigh (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00658060, which also lists 2 linked publications.
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 14 Apr 2008.