Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis

• Register: ClinicalTrials.gov
• Last refreshed on: 29 October 2012
• Main ID: NCT00315497
• Date of registration: 14/04/2006
• Primary sponsor: University of Pennsylvania
• Public title: Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis
• Scientific title: Longitudinal Protocol for Giant Cell Arteritis
• Date of first enrolment: April 2006
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00315497
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

Canada, United States

Contacts

• Name: Peter A. Merkel, MD, MPH
• Affiliation: University of Pennsylvania

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of GCA, meeting at least 3 of the following 5 American College of
Rheumatology (ACR) criteria for the diagnosis of GCA:

1. At least 50 years of age at disease onset

2. New onset or new type of localized pain in the head

3. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or
decreased pulsation unrelated to arteriosclerosis of cervical arteries)

4. ESR of greater than 40 mm in the first hour by the Westergren method

5. Temporal artery biopsy showing vasculitis characterized by a predominance of
mononuclear cell infiltration or granulomatous inflammation, usually with
multinucleated giant cells

Exclusion Criteria:

- Unable to give informed consent and sign the consent form



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Temporal Arteritis

Secondary ID(s)

RDCRN 5502

U54AR057319

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Office of Rare Diseases (ORD)

Rare Diseases Clinical Research Network