Understanding the natural history and outcomes of systemic vasculitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the natural history, pathogenesis, and outcomes of idiopathic systemic vasculitis, which includes conditions like Takayasu's arteritis and Giant Cell arteritis. Participants, including those diagnosed with vasculitis and healthy volunteers, will undergo evaluations by specialized doctors, provide blood and urine samples, and may have imaging tests or biopsies performed. The goal is to identify genetic markers, symptoms, and imaging findings that can help predict disease progression and outcomes over time.

Why it matters

Who can join: the full rules

* 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

EXCLUSION CRITERIA FOR SUBJECTS WITH VASCULITIS:

* Subjects \< 3 years of age
* Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion
* Inability to provide consent, or in the case of minors, assent
* 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

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

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 CRITERIA FOR HEALTHY VOLUNTEERS:

* Volunteers \< 3 years of age risk
* 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

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Peter C Grayson, M.D. — National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Study coordinator: Shanni Liu
• Email: shanni.liu@nih.gov
• Phone: (240) 992-2440

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Characterization of Autoreactive B Cells in Autoimmune Diseases and Immune Deficiencies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.