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Sponsors and Collaborators: |
Office of Rare Diseases (ORD) Rare Diseases Clinical Research Network |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00315497 |
Giant cell arteritis (GCA), also known as temporal arteritis, is a disease that usually only occurs in older adults. GCA causes inflammation of blood vessels, or vasculitis. In order to properly treat this disease, it is critical that the level of disease activity can be determined over the course of the disease. The purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of disease in people with GCA.
Condition |
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Temporal Arteritis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Longitudinal Protocol for Giant Cell Arteritis |
Blood (serum and plasma), urine, and DNA
Estimated Enrollment: | 250 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | April 2016 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
GCA is a rare autoimmune disorder and is the most common type of inflammation of medium- to large-sized blood vessels in the body. It usually only occurs in older adults. The most common symptoms of GCA include headache, pain in the shoulders and hips (polymyalgia rheumatica), pain in the jaw (jaw claudication), fever, and blurred vision. Organ-specific markers of injury or damage as well as direct markers of vascular damage and inflammation are currently used by clinicians to assess GCA disease progression; however, these markers are not very useful in guiding treatment. There are also blood tests that clinicians use to monitor GCA activity, such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), but these tests lack specificity and sensitivity. Most treatments available now for GCA are toxic, therefore if other markers indicating disease activity can be found, it may lead to the development of less toxic treatments. This study will use new scientific methods to identify new biomarkers that can be used to monitor disease activity in GCA patients. These biomarkers may be used to help direct clinical care for GCA patients and assist in future drug development.
This study will last 5 years. Study visits will occur monthly for the first year, then every 3 months thereafter for the remainder of the study. Blood and urine collection will occur at every visit. A physical exam and medical and medication history will occur every 3 months; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use. Participants may have additional study visits if a disease flare or disease-releated complications occur during the study.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Adults with giant cell arteritis. Enrollment will be sequential and participants will have disease in various stages and of different duration.
Inclusion Criteria:
Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA:
Exclusion Criteria:
United States, Maryland | |
The Johns Hopkins Vasculitis Center | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Cynthia Bethea 410-550-4390 cbethea3@jhmi.edu | |
Principal Investigator: Philip \ Seo, MD, MHS | |
United States, Massachusetts | |
Boston University School of Medicine | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Contact: Jessica Martin 617-414-2507 jmartin@bu.edu | |
Principal Investigator: Peter A. Merkel, MD, MPH | |
Principal Investigator: Paul A. Monach, MD | |
United States, Minnesota | |
Mayo Clinic College of Medicine | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Jane Jaquith 507-284-4502 jaquith@mayo.edu | |
Principal Investigator: Steven R. Ytterberg, MD | |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Katherine Tuthill 216-444-5257 TUTHILLK@ccf.org | |
Principal Investigator: Carol A. Langford, MD, MHS | |
Canada, Ontario | |
Mount Sinai Hospital | Recruiting |
Toronto, Ontario, Canada, M5T 3L9 | |
Contact: Sara Sutherland 416-586-8616 SSutherland2@mtsinai.on.ca | |
Principal Investigator: Simon Carette, MD | |
St. Joseph's Healthcare | Recruiting |
Hamilton, Ontario, Canada | |
Contact: Sandra Messier 905-522-1155 ext 35873 smessier@stjoes.ca | |
Principal Investigator: Nader A. Khalidi, MD |
Study Chair: | Peter A. Merkel, MD, MPH | Boston University |
Principal Investigator: | Carol A. Langford, MD, MHS | The Cleveland Clinic |
Principal Investigator: | Philip Seo, MD, MHS | Johns Hopkins Vasculitis Center |
Principal Investigator: | Steven R. Yetterberg, MD | Mayo Clinic |
Responsible Party: | Boston University School of Medicine ( Peter A. Merkel, MD, MPH ) |
Study ID Numbers: | RDCRN 5502, U54RR019497, VCRC 5502 |
Study First Received: | April 14, 2006 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00315497 History of Changes |
Health Authority: | United States: Federal Government |
Giant Cell Arteritis |
Vasculitis Autoimmune Diseases Skin Diseases Vascular Diseases Central Nervous System Diseases Rheumatic Diseases Brain Diseases Cerebrovascular Disorders Temporal Arteritis |
Hortons Disease Muscular Diseases Musculoskeletal Diseases Polymyalgia Rheumatica Giant Cell Arteritis Connective Tissue Diseases Arteritis Autoimmune Diseases of the Nervous System |
Skin Diseases, Vascular Autoimmune Diseases Vasculitis Immune System Diseases Skin Diseases Nervous System Diseases Vascular Diseases Central Nervous System Diseases Rheumatic Diseases Vasculitis, Central Nervous System |
Brain Diseases Cerebrovascular Disorders Muscular Diseases Musculoskeletal Diseases Giant Cell Arteritis Polymyalgia Rheumatica Connective Tissue Diseases Cardiovascular Diseases Arteritis Autoimmune Diseases of the Nervous System |