Status:
RECRUITING
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Takayasu's Arteritis
Giant Cell Arteritis
Eligibility:
All Genders
3+ years
Brief Summary
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 predic...
Detailed Description
The purpose of this protocol is to study the natural history of idiopathic systemic vasculitis in children and adults. The idiopathic vasculitides are a group of rare, systemic diseases involving infl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 29 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2050
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT02257866
Start Date
September 29 2014
End Date
January 1 2050
Last Update
November 26 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892