Recruiting

Observational Study

Sponsor:

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Code:

NCT02257866

Conditions

Takayasu's Arteritis

Giant Cell Arteritis

Polyarteritis Nodosa

Relapsing Polychondritis

ANCA-Associated Vasculitis

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Accepted

Study Details

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 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.

Conditions

Takayasu's Arteritis

Giant Cell Arteritis

Polyarteritis Nodosa

Relapsing Polychondritis

ANCA-Associated Vasculitis

Study ID

NCT02257866

Start date

Sep 29, 2014

Status verified date

Aug 7, 2026

Completion date

Jan 1, 2050

Anticipated

Primary completion date

Jan 1, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Accepted

  • 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

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Volunteers

Patients without known auto immune diseases

Vasculitis

Patients with known or suspected vasculitis age 5 or older

Primary outcome measure

  • To study the pathogenesis of patients affected with idiopathic systemic vasculitis, including clinical, radiographic, immunological, and genetic characteristics of the disease [ Time Frame: end of study ]

Central Contacts and Locations

Central contacts

Shanni Liu

(240) 992-2440shanni.liu@nih.gov

Peter C Grayson, M.D.

(240) 731-4558peter.grayson@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Last update posted

Aug 17, 2026

Last verified

Aug 7, 2026

Keywords

  • Polyarteritis Nodosa
  • Takayasu's Arthritis
  • Giant Cell Arthritis
  • Relapsing Polychondritis
  • Antineutrophil Cytoplasmic Antibodies
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) on 2026-08-17.