Takayasu's ArteritisNCT00315471
Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis
An observational study of Takayasu's Arteritis, run by University of Pennsylvania at 9 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Takayasu's Arteritis
- How many people
- 224 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Apr 2006to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with Takayasu's arteritis. Enrollment will be sequential and participants will have disease in various stages and of different duration.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston University School of Medicine
Boston, Massachusetts, 02118
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Mayo Clinic College of Medicine
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84112
Canada2 sites
St. Joseph's Healthcare
Hamilton, Ontario
Mount Sinai Hospital
Toronto, Ontario, M5T 3L9
About this study
Official title: VCRC Longitudinal Protocol for Takayasu's Arteritis
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.
Read the 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
- Keywords
- Vasculitis
- Medical subject headings
- Takayasu Arteritis, Vasculitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Discover biomarkers in Takayasu's arteritis capable of measuring disease activity and response to treatment.
Measured: Study completion
Secondary outcomes (1)
Measure the predictive value of biomarkers for clinical outcome in Takayasu's arteritis.
Measured: Study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Takayasu's ArteritisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Rare Diseases (ORD), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Rare Diseases Clinical Research Network
- Responsible party
- Principal investigator, Peter Merkel, University of Pennsylvania
- Investigators
- Peter A. Merkel, MD, MPH, Study director, Vasculitis Clinical Research Consortium (VCRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315471
- Sponsor's protocol ID
- VCRC5503
- Other IDs
- U54AR057319
- Status last verified
- Jul 2022
- First submitted
- 14 Apr 2006
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 16416104Ng 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.
PubMed 16403827Park 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.
PubMed 16352633Tripathy 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.
PubMed 16337833Park 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.
PubMed 16195161
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VCRC Longitudinal Protocol for Takayasu's Arteritis
- ClinicalTrials.gov ID
- NCT00315471
- Acronym / sponsor ID
- VCRC5503
- Conditions
- Takayasu's Arteritis
- Keywords
- Vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Office of Rare Diseases (ORD), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Rare Diseases Clinical Research Network
- Study start
- Apr 2006 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 18 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with Takayasu's arteritis. Enrollment will be sequential and participants will have disease in various stages and of different duration.
Key inclusion criteria (8 listed)
- 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:
- Parental consent for children under the age of 18
Key exclusion criteria (8 listed)
- Arteriographic lesions that could be entirely due to atherosclerosis
- Fibromuscular dysplasia
- Cogan's syndrome
- Behcet's disease
- Sarcoidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Discover biomarkers in Takayasu's arteritis capable of measuring disease activity and response to treatment.
Time frame: Study completion
1 secondary outcome
Measure the predictive value of biomarkers for clinical outcome in Takayasu's arteritis.
Time frame: Study completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Background: PubMed 16416104Sueyoshi 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.
- Background: PubMed 16403827Ng 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.
- Background: PubMed 16352633Park 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.
- Background: PubMed 16337833Tripathy 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.
- Background: PubMed 16195161Park 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.
- Vasculitis Clinical Research ConsortiumLink provided by the sponsor.
- Rare Diseases Clinical Research NetworkLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A. Merkel, MD, MPH study director
Vasculitis Clinical Research Consortium (VCRC)
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Takayasu's Arteritis, run by University of Pennsylvania at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discover biomarkers in Takayasu's arteritis capable of measuring disease activity and response to treatment. (time frame: Study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00315471, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.