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Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission

Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00323440
Enrollment
0
Registered
2006-05-09
Start date
2008-08-31
Completion date
2016-08-31
Last updated
2017-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Mediterranean Fever

Keywords

Familial Mediterranean fever, Inflammation, Attacks, Remission, RNA, Cytokines, Inflammatory proteins, MEFV, mutations, Colchicine, Treatment, microarray RNA analysis

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.

Interventions

None listed

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026