Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Sheba Medical Center National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
---|---|
Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00323440 |
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: | Prospective |
Official Title: | Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission |
Estimated Enrollment: | 80 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sheba Medical Center ( Avi Livneh MD/ Head Medicine F ) |
Study ID Numbers: | SHEBA-06-4126-AL-CTIL |
Study First Received: | May 7, 2006 |
Last Updated: | May 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00323440 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Familial Mediterranean fever Inflammation Attacks Remission RNA Cytokines |
Inflammatory proteins MEFV mutations Colchicine Treatment microarray RNA analysis |
Bacterial Infections Fever Signs and Symptoms Autoimmune Diseases Genetic Diseases, Inborn |
Colchicine Familial Mediterranean Fever Brucellosis Gram-Negative Bacterial Infections Inflammation |
Bacterial Infections Fever Signs and Symptoms Autoimmune Diseases Immune System Diseases |
Genetic Diseases, Inborn Body Temperature Changes Familial Mediterranean Fever Brucellosis Gram-Negative Bacterial Infections |