Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis

Completed

• Conditions: Temporal Arteritis

• Registration Number: NCT00315497
• Lead Sponsor: University of Pennsylvania

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 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.

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 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 Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-14
• Study First Submitted QC: 2006-04-14
• Study First Posted: 2006-04-18
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discover biomarkers in Giant cell arteritis capable of measuring disease activity and response to treatment.	Study completion

Secondary Outcome Measures

Name	Time	Method
Measure the predictive value of biomarkers for clinical outcome in Giant cell arteritis.	Study completion.

Trial Locations

Locations (9)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

Mayo Clinic College of Medicine; 🇺🇸 Rochester, Minnesota, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

St. Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Boston University School of Medicine; 🇺🇸 Boston, Massachusetts, United States