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Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis
This study is currently recruiting participants.
Verified by Office of Rare Diseases (ORD), September 2008
First Received: April 14, 2006   Last Updated: September 10, 2008   History of Changes
Sponsors and Collaborators: Office of Rare Diseases (ORD)
Rare Diseases Clinical Research Network
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00315497
  Purpose

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
Temporal Arteritis

MedlinePlus related topics: Polymyalgia Rheumatica Vasculitis
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Longitudinal Protocol for Giant Cell Arteritis

Further study details as provided by Office of Rare Diseases (ORD):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood (serum and plasma), urine, and DNA


Estimated Enrollment: 250
Study Start Date: April 2006
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.

This study will last 5 years. 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-releated complications occur during the study.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with giant cell arteritis. Enrollment will be sequential and participants will have disease in various stages and of different duration.

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 ateriosclerosis 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 conset form
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315497

Locations
United States, Maryland
The Johns Hopkins Vasculitis Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Cynthia Bethea     410-550-4390     cbethea3@jhmi.edu    
Principal Investigator: Philip \ Seo, MD, MHS            
United States, Massachusetts
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Contact: Jessica Martin     617-414-2507     jmartin@bu.edu    
Principal Investigator: Peter A. Merkel, MD, MPH            
Principal Investigator: Paul A. Monach, MD            
United States, Minnesota
Mayo Clinic College of Medicine Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jane Jaquith     507-284-4502     jaquith@mayo.edu    
Principal Investigator: Steven R. Ytterberg, MD            
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Katherine Tuthill     216-444-5257     TUTHILLK@ccf.org    
Principal Investigator: Carol A. Langford, MD, MHS            
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5T 3L9
Contact: Sara Sutherland     416-586-8616     SSutherland2@mtsinai.on.ca    
Principal Investigator: Simon Carette, MD            
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada
Contact: Sandra Messier     905-522-1155 ext 35873     smessier@stjoes.ca    
Principal Investigator: Nader A. Khalidi, MD            
Sponsors and Collaborators
Rare Diseases Clinical Research Network
Investigators
Study Chair: Peter A. Merkel, MD, MPH Boston University
Principal Investigator: Carol A. Langford, MD, MHS The Cleveland Clinic
Principal Investigator: Philip Seo, MD, MHS Johns Hopkins Vasculitis Center
Principal Investigator: Steven R. Yetterberg, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Boston University School of Medicine ( Peter A. Merkel, MD, MPH )
Study ID Numbers: RDCRN 5502, U54RR019497, VCRC 5502
Study First Received: April 14, 2006
Last Updated: September 10, 2008
ClinicalTrials.gov Identifier: NCT00315497     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
Giant Cell Arteritis

Study placed in the following topic categories:
Vasculitis
Autoimmune Diseases
Skin Diseases
Vascular Diseases
Central Nervous System Diseases
Rheumatic Diseases
Brain Diseases
Cerebrovascular Disorders
Temporal Arteritis
Horton’s Disease
Muscular Diseases
Musculoskeletal Diseases
Polymyalgia Rheumatica
Giant Cell Arteritis
Connective Tissue Diseases
Arteritis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Skin Diseases, Vascular
Autoimmune Diseases
Vasculitis
Immune System Diseases
Skin Diseases
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Rheumatic Diseases
Vasculitis, Central Nervous System
Brain Diseases
Cerebrovascular Disorders
Muscular Diseases
Musculoskeletal Diseases
Giant Cell Arteritis
Polymyalgia Rheumatica
Connective Tissue Diseases
Cardiovascular Diseases
Arteritis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009