Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission

Sponsor

Sheba Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00323440

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Familial Mediterranean Fever

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission

Anticipated Study Start Date :

Aug 1, 2008

Anticipated Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Group 1 FMF patients in remission
Group 2 FMF patients during attack
Group 3 FMF patients without colchicine in remission
Group 4 FMF patients without colchicine in attack

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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