Determining Disease Activity Biomarkers in Individuals With Takayasu’s Arteritis

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Brief Title

Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis

Official Title

VCRC Longitudinal Protocol for Takayasu's Arteritis

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.
    


Study Type

Observational


Primary Outcome

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

Secondary Outcome

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

Condition

Takayasu's Arteritis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

250

Start Date

April 2006

Completion Date

September 2022

Primary Completion Date

September 2022

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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Peter A. Merkel, MD, MPH, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00315471

Organization ID

VCRC5503

Secondary IDs

U54AR057319

Responsible Party

Principal Investigator

Study Sponsor

University of Pennsylvania

Collaborators

 Office of Rare Diseases (ORD)

Study Sponsor

Peter A. Merkel, MD, MPH, Study Director, Vasculitis Clinical Research Consortium (VCRC)


Verification Date

May 2021