Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis

Completed

Conditions studied: Temporal Arteritis

In brief

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.

Key facts

Study ID

NCT00315497

Run by

University of Pennsylvania

People needed

426

Starts

2006-04-01

Expected to finish

2019-12-01

Last updated by the study team

2022-07-12

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Unable to give informed consent and sign the consent form

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• Mayo Clinic College of Medicine — Rochester, Minnesota, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Utah — Salt Lake City, Utah, United States
• St. Joseph's Healthcare — Hamilton, Ontario, Canada
• Mount Sinai Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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