Clinical trial NCT00323440: Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission
Official title: Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Familial Mediterranean Fever
Keywords: Familial Mediterranean fever
Inflammation
Attacks
Remission
RNA
Cytokines
Inflammatory proteins
MEFV
mutations
Colchicine
Treatment
microarray RNA analysis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: FMF patients recruited at clinic on follow-up visits and FMF patients arriving at ER during attacks

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Avi Livneh, MD
role: PRINCIPAL_INVESTIGATOR
References: