Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis

NCT ID: NCT00315471

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 224 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Takayasu's Arteritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Office of Rare Diseases (ORD)

NIH

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Rare Diseases Clinical Research Network

NETWORK

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Peter Merkel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter A. Merkel, MD, MPH

Role: STUDY_DIRECTOR

Vasculitis Clinical Research Consortium (VCRC)

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Boston University School of Medicine

Boston, Massachusetts, United States

Mayo Clinic College of Medicine

Rochester, Minnesota, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Utah

Salt Lake City, Utah, United States

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 16416104 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16403827 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16352633 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16337833 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16195161 (View on PubMed)

Related Links

http://rarediseasesnetwork.org/cms/vcrc

Vasculitis Clinical Research Consortium

http://rarediseasesnetwork.org

Rare Diseases Clinical Research Network

Other Identifiers

U54AR057319

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VCRC5503

Identifier Type: -

Identifier Source: org_study_id