Clinical trial NCT00315471: Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis
Official title: VCRC Longitudinal Protocol for Takayasu's Arteritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Takayasu's Arteritis
Keywords: Vasculitis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Office of Rare Diseases (ORD)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Rare Diseases Clinical Research Network
First posted: 2006-04-18
Enrollment: 224
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Discover biomarkers in Takayasu's arteritis capable of measuring disease activity and response to treatment.
timeFrame: Study completion
Secondary outcomes:
measure: Measure the predictive value of biomarkers for clinical outcome in Takayasu's arteritis.
timeFrame: Study completion.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic College of Medicine
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Vasculitis Clinical Research Consortium (VCRC)
name: Peter A. Merkel, MD, MPH
role: STUDY_DIRECTOR
References:
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. doi: 10.1007/s00330-005-0095-z. Epub 2006 Jan 14.
citation: 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.
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. doi: 10.1093/rheumatology/kei266. Epub 2005 Dec 13.
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. doi: 10.1016/j.clim.2005.09.010. Epub 2005 Dec 7.
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. doi: 10.1080/03009740510026526.