Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis

VCRC Longitudinal Protocol for Takayasu's Arteritis

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 224

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • St. Joseph's Healthcare
    • Toronto, Ontario, Canada, M5T 3L9
      • Mount Sinai Hospital
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston University School Of Medicine
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic College of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Discover biomarkers in Takayasu's arteritis capable of measuring disease activity and response to treatment.	Study completion

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure the predictive value of biomarkers for clinical outcome in Takayasu's arteritis.	Study completion.

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Rare Diseases Clinical Research Network; Office of Rare Diseases (ORD)
• Investigators: Study Director: Peter A. Merkel, MD, MPH, Vasculitis Clinical Research Consortium (VCRC)

Publications and helpful links

General Publications

• Sueyoshi E, Sakamoto I, Ogawa Y, Uetani M. Diagnosis of perfusion abnormality of the pulmonary artery in Takayasu's arteritis using contrast-enhanced MR perfusion imaging. Eur Radiol. 2006 Jul;16(7):1551-6. doi: 10.1007/s00330-005-0095-z. Epub 2006 Jan 14.
• Ng WF, Fantin F, Ng C, Dockery F, Schiff R, Davies KA, Rajkumar C, Mason JC. Takayasu's arteritis: a cause of prolonged arterial stiffness. Rheumatology (Oxford). 2006 Jun;45(6):741-5. doi: 10.1093/rheumatology/kei274. Epub 2006 Jan 10.
• Park MC, Lee SW, Park YB, Lee SK. Serum cytokine profiles and their correlations with disease activity in Takayasu's arteritis. Rheumatology (Oxford). 2006 May;45(5):545-8. doi: 10.1093/rheumatology/kei266. Epub 2005 Dec 13.
• Tripathy NK, Gupta PC, Nityanand S. High TNF-alpha and low IL-2 producing T cells characterize active disease in Takayasu's arteritis. Clin Immunol. 2006 Feb-Mar;118(2-3):154-8. doi: 10.1016/j.clim.2005.09.010. Epub 2005 Dec 7.
• Park MC, Lee SW, Park YB, Chung NS, Lee SK. Clinical characteristics and outcomes of Takayasu's arteritis: analysis of 108 patients using standardized criteria for diagnosis, activity assessment, and angiographic classification. Scand J Rheumatol. 2005 Jul-Aug;34(4):284-92. doi: 10.1080/03009740510026526.

Helpful Links

• Vasculitis Clinical Research Consortium
• Rare Diseases Clinical Research Network

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2006
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: April 14, 2006
• First Submitted That Met QC Criteria: April 14, 2006
• First Posted (Estimate): April 18, 2006

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Vasculitis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Vasculitis; Skin Diseases, Vascular; Aortic Diseases; Arteritis; Takayasu Arteritis; Aortic Arch Syndromes
• Other Study ID Numbers: VCRC5503; U54AR057319 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No