Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis

NCT00315471 | Completed DMC

• 2 other identifiers: VCRC5503U54AR057319
• Study Type: observational
• Target: 224
• Locations: 2 countries
• Sites: 9

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.

Conditions

Takayasu's Arteritis

Keywords

Vasculitis

Outcome Measures

Primary Outcomes (1)

• Discover biomarkers in Takayasu's arteritis capable of measuring disease activity and response to treatment.

  Study completion

Secondary Outcomes (1)

• Measure the predictive value of biomarkers for clinical outcome in Takayasu's arteritis.

  Study completion.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Office of Rare Diseases (ORD): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Rare Diseases Clinical Research Network: collaborator

Study Sites (9)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Mayo Clinic College of Medicine

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

Related Publications (5)

• 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.

  PMID: 16416104 BACKGROUND

• 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.

  PMID: 16403827 BACKGROUND

• 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.

  PMID: 16352633 BACKGROUND

• 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.

  PMID: 16337833 BACKGROUND

• 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.

  PMID: 16195161 BACKGROUND

Related Links

• Vasculitis Clinical Research Consortium
• Rare Diseases Clinical Research Network

Biospecimen

Retention: SAMPLES WITH DNA

Blood (serum and plasma), urine, and DNA

MeSH Terms

Conditions

Takayasu Arteritis; Vasculitis

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter A. Merkel, MD, MPH

  Vasculitis Clinical Research Consortium (VCRC)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2006
• First Posted: April 18, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (7)