Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis

Takayasu's Arteritis Clinical Trial

Official title:

VCRC Longitudinal Protocol for Takayasu's Arteritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315471
• Other study ID #: VCRC5503
• Secondary ID: U54AR057319
• Status: Completed
• Start date: April 2006
• Est. completion date: December 2019

Study information

• Verified date: July 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Takayasu Arteritis
• Takayasu's Arteritis

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic College of Medicine	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah

Sponsors (4)

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

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (5)

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. Epub 2006 Jan 10. — View Citation

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. — View Citation

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. Epub 2005 Dec 13. — View Citation

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. Epub 2006 Jan 14. — View Citation

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. Epub 2005 Dec 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discover biomarkers in Takayasu's arteritis capable of measuring disease activity and response to treatment.		Study completion
Secondary	Measure the predictive value of biomarkers for clinical outcome in Takayasu's arteritis.		Study completion.

External Links

•   Rare Diseases Clinical Research Network
•   Vasculitis Clinical Research Consortium