Understanding the natural history and outcomes of systemic vasculitis
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
This study is trying to understand how systemic vasculitis affects people over time and what signs can help predict how the disease will progress, involving both patients with vasculitis and healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02257866 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 3 and older with a diagnosis of vasculitis or those suspected of having it, as well as healthy volunteers.
Not a fit: Patients under 3 years of age or those with active malignancies or infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of systemic vasculitis, potentially enhancing patient outcomes.
How similar studies have performed: While there have been studies on specific types of vasculitis, this comprehensive approach to understanding the natural history of multiple forms of idiopathic vasculitis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: SUBJECTS WITH VASCULITIS * Subjects who fulfill modified versions of the 1990 American College of Rheumatology (ACR) Classification Criteria for GPA31 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 HEALTHY VOLUNTEERS -Volunteers able to provide consent, or in the case of minors, assent EXCLUSION CRITERIA: SUBJECTS WITH VASCULITIS: * Subjects less than 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 HEALTHY VOLUNTEERS * Volunteers less than 3 years of age * Diagnosis of vasculitis or other autoimmune/autoinflamamtory 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 (eg coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participating in nasal brushing studies
Where this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.