Studying how idiopathic systemic vasculitis develops and progresses over time
Studies vasculitis, which inflames blood vessels, by following people over time and testing blood samples.
Plain-language title generated from the registry record
Registry title: Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Key facts
- Where
- Bethesda, United StatesSee the site
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Trial code
- NCT02257866
- Record updated
- 29 October 2026
- Original description
Background:Read full original descriptionShow less
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Background:
- Vasculitis is a group of diseases that inflame and damage blood vessels and tissue. It can cause many medical problems. Few tests can diagnose the disease, and none can reliably predict a relapse. Researchers want to study people's genes and follow people over time to see how the disease affects them.
Objective:
- To learn the signs, symptoms, imaging tests, genetic markers, and blood tests that can help identify people with vasculitis and predict what will happen to them over time.
Eligibility:
* People age 3 and older who have or are thought to have vasculitis, or are related to someone with it. * Healthy volunteers.
Design:
* Participants will be evaluated by a doctor who has expertise caring for patients with vasculitis. * Participants will give a blood sample. Some will give a urine sample. * Some participants may have brushings or biopsies taken from the inside lining of the nose. * Images of participants' blood vessels may be taken using scans. For some scans, participants will lie on a table that moves in and out of a cylinder that takes pictures. For some scans, a contrast agent may be injected into an arm vein. Other scans may use a radioactive form of sugar. Healthy minors will not have scans. * Some participants will answer questionnaires. - Some participants will have their tests done at NIH. Others will have their doctor take the blood, saliva, or cheek swab samples and send them to NIH. * Some participants will have one visit lasting 1-2 (but sometimes up to 4) days. Some participants may have follow-up visits every 3 - 6 months, indefinitely.
Inclusion: Healthy volunteers will be recruited to serve as controls for studies on peripheral blood samples; -Volunteers able to provide consent, or in the case of minors, assent.
Exclusion: Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion; Subjects with bleeding diathesis or on anticoagulant medications (e.g. coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participation in nasal brushing or biopsy studies; Reason for early termination; -Withdrawal of consent; Diagnosis of vasculitis or other autoimmune/autoinflammatory disease, including systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, mixed connective tissue disease or any overlap autoimmune syndrome; Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion; Pregnant (by history of last menstrual period) or breast-feeding subjects; Subjects with bleeding diathesis or taking anticoagulant medications (e.g. coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participating in nasal brushing studies; Subjects < 3 years of age; Volunteers < 3 years of age risk; Inability to provide consent, or in the case of minors, assent.
INCLUSION CRITERIA SUBJECTS WITH VASCULITIS:; Subjects with known or suspected diagnosis of idiopathic systemic vasculitis will be evaluated either at the outpatient or inpatient unit of the Clinical Center as indicated; Subjects who fulfill modified versions of the 1990 American College of Rheumatology (ACR) Classification Criteria for GPA and PAN; Subjects who fulfill the 1990 ACR Classification Criteria for EGPA, GCA, and TAK; Subjects who fulfill the 2012 Chapel Hill Nomenclature definition for MPA; Subjects with other suspected systemic or single-organ vasculitides.