Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission

NCT00323440 | Withdrawn DMC

• 1 other identifier: SHEBA-06-4126-AL-CTIL
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Familial Mediterranean Fever

Keywords

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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

FMF patients recruited at clinic on follow-up visits and FMF patients arriving at ER during attacks

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Familial Mediterranean Fever; Inflammation

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Avi Livneh, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2006
• First Posted: May 9, 2006
• Study Start: August 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2016
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

IL (1)