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Protocol Details

Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-AR-0200

Sponsoring Institute

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

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 5
Max Age: NA

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Polyarteritis Nodosa;
Takayasu's Arthritis;
Giant Cell Arthritis;
Relapsing Polychondritis;
Antineutrophil Cytoplasmic Antibodies

Recruitment Keyword(s)

None

Condition(s)

Takayasu's Arteritis;
Giant Cell Arteritis;
Polyarteritis Nodosa;
Relapsing Polychondritis;
ANCA-Associated Vasculitis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Arthritis and Musculoskeletal and Skin Diseases

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 5 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.

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Eligibility

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 5 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 5 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


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Citations:

Carmona-Rivera C, Purmalek MM, Moore E, Waldman M, Walter PJ, Garraffo HM, Phillips KA, Preston KL, Graf J, Kaplan MJ, Grayson PC. A role for muscarinic receptors in neutrophil extracellular trap formation and levamisole-induced autoimmunity. JCI Insight. 2017 Feb 9;2(3):e89780. doi: 10.1172/jci.insight.89780.

Grayson PC, Alehashemi S, Bagheri AA, Civelek AC, Cupps TR, Kaplan MJ, Malayeri AA, Merkel PA, Novakovich E, Bluemke DA, Ahlman MA. (18) F-Fluorodeoxyglucose-Positron Emission Tomography As an Imaging Biomarker in a Prospective, Longitudinal Cohort of Patients With Large Vessel Vasculitis. Arthritis Rheumatol. 2018 Mar;70(3):439-449. doi: 10.1002/art.40379. Epub 2018 Feb 6.

Quinn KA, Ahlman MA, Malayeri AA, Marko J, Civelek AC, Rosenblum JS, Bagheri AA, Merkel PA, Novakovich E, Grayson PC. Comparison of magnetic resonance angiography and (18)F-fluorodeoxyglucose positron emission tomography in large-vessel vasculitis. Ann Rheum Dis. 2018 Aug;77(8):1165-1171. doi: 10.1136/annrheumdis-2018-213102. Epub 2018 Apr 17.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Peter C. Grayson, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
BG 10 RM 12N248
10 CENTER DR
BETHESDA MD 20814
(301) 827-9187
peter.grayson@nih.gov

Elaine M. Novakovich
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
Building 10
Room 6N226
10 Center Drive
Bethesda, Maryland 20892
(301) 451-1450
enovakovich@mail.cc.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02257866

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