Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis
|Brief Title †||Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis|
|Official Title †||Longitudinal Protocol for Giant Cell Arteritis|
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.
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.
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-related complications occur during the study.
|Study Type †||Observational|
|Study Design †||Observational Model: Cohort, Time Perspective: Prospective|
|Primary Outcome Measure †||Discover biomarkers in Giant cell arteritis capable of measuring disease activity and response to treatment.|
|Secondary Outcome Measure †||Measure the predictive value of biomarkers for clinical outcome in Giant cell arteritis.|
|Study Arms / Comparison Groups|
|* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.|
|Recruitment Status †|
|Estimated Enrollment †||500|
|Start Date †||April 2006|
|Completion Date||April 2016|
|Primary Completion Date||April 2016|
|Eligibility Criteria †||
|Ages||50 Years - N/A|
|Accepts Healthy Volunteers||No|
|Location Countries †||Canada, United States,|
|NCT ID †||NCT00315497|
|Organization ID||RDCRN 5502|
|Secondary IDs ††||U54AR057319|
|Study Sponsor †||University of Pennsylvania|
|Investigators †||Study Chair: Peter A. Merkel, MD, MPH, University of Pennsylvania|
|Information Provided By||University of Pennsylvania|
|Verification Date||November 2013|
|First Received Date †||April 14, 2006|
|Last Updated Date||November 22, 2013|
†† WHO trial registration data element that is required only if it exists.