Viewing Study NCT00323440



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Study NCT ID: NCT00323440
Status: WITHDRAWN
Last Update Posted: 2017-10-11
First Post: 2006-05-07

Brief Title: Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission
Sponsor: Sheba Medical Center
Organization: Sheba Medical Center

Study Overview

Official Title: Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission
Status: WITHDRAWN
Status Verified Date: 2017-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Collaboration could not be established
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 eg 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 categoryTwenty 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 eg 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 categoryTwenty 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None