Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:50 - Any
Updated:3/27/2019
Start Date:April 2006
End Date:April 2019

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Longitudinal Protocol for Giant Cell Arteritis

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.

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.

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
We found this trial at
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Larry Moreland, MD
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Principal Investigator: Paul A. Monach, MD, PhD
Phone: 617-414-2512
Boston University School of Medicine A leader in medical education and research, Boston University School...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Curry Koening, MD, MS
Phone: 801-581-4993
University of Utah Research is a major component in the life of the U benefiting...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Carol A. Langford, MD, MHS
Phone: 216-445-1397
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Hamilton, Ontario
Principal Investigator: Nader A. Khalidi, MD
Phone: 905-522-1155
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Peter Merkel, MD, MPH
Phone: 215-614-4407
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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200 1st St SW
Rochester, Minnesota 55905
(507) 284-2316
Principal Investigator: Steven R. Ytterberg, MD
Phone: 507-284-4502
Mayo Clinic College of Medicine Mayo Medical School enrolls a select class of 50 medical...
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