Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT00315497

Collaborator

Office of Rare Diseases (ORD) (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), Rare Diseases Clinical Research Network (Other)

426

Enrollment

Locations

164

Actual Duration (Months)

47.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Temporal Arteritis

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 Design

Study Type:

Observational

Actual Enrollment :

426 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Longitudinal Protocol for Giant Cell Arteritis

Actual Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Outcome Measures

Primary Outcome Measures

Discover biomarkers in Giant cell arteritis capable of measuring disease activity and response to treatment. [Study completion]

Secondary Outcome Measures

Measure the predictive value of biomarkers for clinical outcome in Giant cell arteritis. [Study completion.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Unable to give informed consent and sign the consent form

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
2	Boston University School of Medicine	Boston	Massachusetts	United States	02118
3	Mayo Clinic College of Medicine	Rochester	Minnesota	United States	55905
4	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
5	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
6	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15222
7	University of Utah	Salt Lake City	Utah	United States	84122
8	St. Joseph's Healthcare	Hamilton	Ontario	Canada
9	Mount Sinai Hospital	Toronto	Ontario	Canada	M5T 3L9

Sponsors and Collaborators

University of Pennsylvania
Office of Rare Diseases (ORD)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Rare Diseases Clinical Research Network

Investigators

Study Chair: Peter A. Merkel, MD, MPH, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Peter Merkel, Professor, University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT00315497

Other Study ID Numbers:

VCRC5502
U54AR057319

First Posted:

Apr 18, 2006

Last Update Posted:

Jul 12, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Peter Merkel, Professor, University of Pennsylvania

Giant Cell Arteritis

Additional relevant MeSH terms:

Polymyalgia Rheumatica

Giant Cell Arteritis

Arteritis

Study Results

No Results Posted as of Jul 12, 2022