- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00323440
Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission
Familial Mediterranean fever (FMF) is a genetic disease, caused by mutations in the FMF gene, entitled MEFV. The disease is characterized by painful attacks of inflammation in sites lined by serous membranes (e.g. abdominal pain caused by inflammation of the peritoneum, a serous membrane surrounding all internal organs within the abdomen). Continuous colchicine treatment prevents attacks in most patients. The pathogenesis of the disease, what leads to the attacks and how colchicine helps, are questions not yet resolved. Elucidating the role of the inflammatory proteins is an important step towards the understanding of these questions. To date only small numbers of cytokines and inflammatory proteins have been studied individually. We propose to study a large number of these proteins in the RNA and protein levels addressing the interaction between them and the effect of colchicine on their expression.
Blood samples will be drawn from consenting patients in remission, during attacks, under and without colchicine treatment. (20 patients in each category).Twenty healthy volunteers will donate control blood samples for the study. RNA will be produced from the neutrophils, and cytokines and various proteins' RNA expression will be determined. Major expressed proteins will be measured in the same samples and the results will be analyzed with regard to the activity of the disease, MEFV mutations and colchicine treatment status. The information obtained by the study may allow us to determine the sequence of events associated with FMF attack development, and perhaps take us one step further in the understanding of the pathogenesis of the disease.
Study Overview
Status
Conditions
Detailed Description
Familial Mediterranean fever (FMF) is a genetic disease, caused by mutations in the FMF gene, entitled MEFV. The disease is characterized by painful attacks of inflammation in sites lined by serous membranes (e.g. abdominal pain caused by inflammation of the peritoneum, a serous membrane surrounding all internal organs within the abdomen). Continuous colchicine treatment prevents attacks in most patients. The pathogenesis of the disease, what leads to the attacks and how colchicine helps, are questions not yet resolved. Elucidating the role of the inflammatory proteins is an important step towards the understanding of these questions. To date only small numbers of cytokines and inflammatory proteins have been studied individually. We propose to study a large number of these proteins in the RNA and protein levels addressing the interaction between them and the effect of colchicine on their expression.
Blood samples will be drawn from consenting patients in remission, during attacks, under and without colchicine treatment. (20 patients in each category).Twenty healthy volunteers will donate control blood samples for the study. RNA will be produced from the neutrophils, and cytokines and various proteins' RNA expression will be determined. Major expressed proteins will be measured in the same samples and the results will be analyzed with regard to the activity of the disease, MEFV mutations and colchicine treatment status. The information obtained by the study may allow us to determine the sequence of events associated with FMF attack development, and perhaps take us one step further in the understanding of the pathogenesis of the disease.
Study Type
Contacts and Locations
Study Locations
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Tel Hashomer, Israel, 52621
- Sheba Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- FMF patients, agreeing with diagnostic criteria, in attack or remission, under or without colchicine treatment.
- Age 18 or older
- Male or female
- all ethnic groups arriving for treatment or routine follow up appointment
- Written Consent to participate and donate blood for protein, RNA and DNA analyses.
Exclusion Criteria:
- Younger than 18
- Patients that use anti inflammatory medications, other than colchicine
- Patients who in addition to FMF suffer from another acute infectious or inflammatory disease
- Patients who in addition to FMF suffer from another chronic infectious or inflammatory or autoimmune disease.
- Amyloidosis
- Pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
FMF patients in remission
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Group 2
FMF patients during attack
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Group 3
FMF patients without colchicine in remission
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Group 4
FMF patients without colchicine in attack
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-06-4126-AL-CTIL
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National Human Genome Research Institute (NHGRI)Merck Sharp & Dohme LLC; Duke University; University of Massachusetts, WorcesterRecruitingFever | Genetic Diseases | Familial Mediterranean Fever (FMF) | Autoinflammation | Periodic Fever | ROSAH | ALPK1United States
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Sohag UniversityNot yet recruitingFamilial Mediterranean FeverEgypt
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Aristea Therapeutics, Inc.WithdrawnFamilial Mediterranean FeverIsrael, Turkey
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University Hospital TuebingenCompleted
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Novartis PharmaceuticalsCompletedFamilial Mediterranean FeverTurkey
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Sheba Medical CenterUnknownFamilial Mediterranean FeverIsrael