Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00315471
Recruitment Status : Active, not recruiting
First Posted : April 18, 2006
Last Update Posted : October 10, 2019
Office of Rare Diseases (ORD)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Rare Diseases Clinical Research Network
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania

Brief Summary:
Takayasu's arteritis is a rare disorder that causes swelling and damage to the large arteries in the body, such as the aorta. In order to ensure proper treatment, measuring disease activity is critical. The purpose of this study is to establish new biological markers (biomarkers) to assess the severity of disease in people with Takayasu's arteritis.

Condition or disease
Takayasu's Arteritis

Detailed Description:

Takayasu's arteritis is a chronic inflammatory condition that affects the aorta, the largest blood vessel in the body, and its branches. Inflammation causes segments of the vessels to become narrowed, blocked, or even stretched, possibly resulting in aneurysms. The disease is very rare but most commonly occurs in young Asian women. Symptoms may include arm pain with use, decreased or absent pulses, lightheadedness or dizziness, headaches, and visual disturbances. Many individuals with Takayasu' arteritis, however, have no apparent symptoms despite disease activity. Additionally, current tests used to measure vessel inflammation are considered unreliable and inconsistent. It is therefore very difficult to determine the extent of disease activity in a person with Takayasu's arteritis. This study will use novel scientific methods to establish new biomarkers that can be used to monitor disease activity in individuals with Takayasu's arteritis. These biomarkers may be used to help direct clinical care 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 examination, disease assessment, and review of medications will occur every 3 months; participants may also be asked to complete various questionnaires. Diagnostic testing, which may include chest radiograph, echocardiogram, magnetic resonance imaging, or angiography, will occur every 6 months. Tobacco, alcohol, and drug use will be assessed on a yearly basis. Participants may have additional study visits if a disease flare or disease-related complications occur during the study.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: VCRC Longitudinal Protocol for Takayasu's Arteritis
Actual Study Start Date : April 2006
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Discover biomarkers in Takayasu's arteritis capable of measuring disease activity and response to treatment. [ Time Frame: Study completion ]

Secondary Outcome Measures :
  1. Measure the predictive value of biomarkers for clinical outcome in Takayasu's arteritis. [ Time Frame: Study completion. ]

Biospecimen Retention:   Samples With DNA
Blood (serum and plasma), urine, and DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with Takayasu's arteritis. Enrollment will be sequential and participants will have disease in various stages and of different duration.

Inclusion Criteria:

  • Evidence of arteriogram abnormalities compatible with Takayasu's arteritis (includes conventional dye angiography, magnetic resonance angiography, or computed tomography angiography)
  • Evidence of one of the following criteria:

    1. Age at disease onset of 50 years or younger
    2. Claudication of the arms or legs
    3. Decreased brachial artery pulse (one or both arteries)
    4. Blood pressure difference between the arms of at least 10 mm Hg
    5. Bruit over the subclavian arteries or aorta
  • Parental consent for children under the age of 18

Exclusion Criteria:

  • Arteriographic lesions that could be entirely due to atherosclerosis
  • Fibromuscular dysplasia
  • Cogan's syndrome
  • Behcet's disease
  • Sarcoidosis
  • Kawasaki disease
  • Giant cell arteritis (large vessel vasculitis and at least 50 years old)
  • Syphilis or other infectious forms of large vessel vasculitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00315471

Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, Minnesota
Mayo Clinic College of Medicine
Rochester, Minnesota, United States, 55905
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada
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
Layout table for investigator information
Study Director: Peter A. Merkel, MD, MPH Vasculitis Clinical Research Consortium (VCRC)

Additional Information:
Layout table for additonal information
Responsible Party: Peter Merkel, Professor, University of Pennsylvania Identifier: NCT00315471    
Other Study ID Numbers: VCRC5503
U54AR057319 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2006    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peter Merkel, University of Pennsylvania:
Additional relevant MeSH terms:
Layout table for MeSH terms
Takayasu Arteritis
Aortic Arch Syndromes
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases