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Trial record 3 of 37 for:    FAMILIAL MEDITERRANEAN FEVER

Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission

This study has been withdrawn prior to enrollment.
(Collaboration could not be established)
Sponsor:
Collaborator:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00323440
First received: May 7, 2006
Last updated: May 18, 2008
Last verified: May 2008
  Purpose

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
Familial Mediterranean Fever

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 80
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323440

Locations
Israel
Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Avi Livneh, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Avi Livneh MD/ Head Medicine F, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00323440     History of Changes
Other Study ID Numbers: SHEBA-06-4126-AL-CTIL
Study First Received: May 7, 2006
Last Updated: May 18, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Familial Mediterranean fever
Inflammation
Attacks
Remission
RNA
Cytokines
Inflammatory proteins
MEFV
mutations
Colchicine
Treatment
microarray RNA analysis

Additional relevant MeSH terms:
Brucellosis
Familial Mediterranean Fever
Fever
Hereditary Autoinflammatory Diseases
Bacterial Infections
Body Temperature Changes
Genetic Diseases, Inborn
Gram-Negative Bacterial Infections
Signs and Symptoms
Skin Diseases
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 24, 2014