Status:
COMPLETED
Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Office of Rare Diseases (ORD)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Temporal Arteritis
Eligibility:
All Genders
50+ years
Brief Summary
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...
Detailed Description
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 G...
Eligibility Criteria
Inclusion
- Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA:
- At least 50 years of age at disease onset
- New onset or new type of localized pain in the head
- Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation unrelated to arteriosclerosis of cervical arteries)
- ESR of greater than 40 mm in the first hour by the Westergren method
- Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells
Exclusion
- Unable to give informed consent and sign the consent form
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT00315497
Start Date
April 1 2006
End Date
December 1 2019
Last Update
July 12 2022
Active Locations (9)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
3
Mayo Clinic College of Medicine
Rochester, Minnesota, United States, 55905
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195