Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis

NCT ID: NCT00315497

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 426 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2019-12-31

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.

Conditions

Temporal Arteritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Office of Rare Diseases (ORD)

NIH

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

Rare Diseases Clinical Research Network

NETWORK

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Peter Merkel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter A. Merkel, MD, MPH

Role: STUDY_CHAIR

University of Pennsylvania

Locations

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

Countries

United States; Canada

References

Gonzalez-Gay MA, Amoli MM, Garcia-Porrua C, Ollier WE. Genetic markers of disease susceptibility and severity in giant cell arteritis and polymyalgia rheumatica. Semin Arthritis Rheum. 2003 Aug;33(1):38-48. doi: 10.1053/sarh.2002.50025.

Reference Type: BACKGROUND

PMID: 12920695 (View on PubMed)

Goronzy JJ, Weyand CM. Cytokines in giant-cell arteritis. Cleve Clin J Med. 2002;69 Suppl 2:SII91-4. doi: 10.3949/ccjm.69.suppl_2.sii91.

Reference Type: BACKGROUND

PMID: 12086274 (View on PubMed)

Weyand CM, Fulbright JW, Hunder GG, Evans JM, Goronzy JJ. Treatment of giant cell arteritis: interleukin-6 as a biologic marker of disease activity. Arthritis Rheum. 2000 May;43(5):1041-8. doi: 10.1002/1529-0131(200005)43:53.0.CO;2-7.

Reference Type: BACKGROUND

PMID: 10817557 (View on PubMed)

Weyand CM, Goronzy JJ. Giant-cell arteritis and polymyalgia rheumatica. Ann Intern Med. 2003 Sep 16;139(6):505-15. doi: 10.7326/0003-4819-139-6-200309160-00015.

Reference Type: BACKGROUND

PMID: 13679329 (View on PubMed)

Related Links

https://www.rarediseasesnetwork.org/cms/vcrc/

Vasculitis Clinical Research Network

https://www.rarediseasesnetwork.org/

Rare Disease Clinical Research Network

Other Identifiers

U54AR057319

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VCRC5502

Identifier Type: -

Identifier Source: org_study_id