RecruitingNot Applicable

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

United States4,000 participantsStarted 2014-09-29

Plain-language 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.

Who can participate

Age range

3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

Volunteers able to provide consent, or in the case of minors, assent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a natural history study rather than a treatment trial, what does participating actually involve for me — things like extra blood draws, imaging, or clinic visits — and how would that fit into my current care schedule?
2This study is looking at the underlying causes and characteristics of conditions like Takayasu's arteritis, giant cell arteritis, and ANCA-associated vasculitis — would the researchers share any findings from my genetic or immunological tests back with me or my care team that could actually influence my treatment?
3Because this trial isn't testing a new therapy, could joining it run alongside whatever treatment plan you're already recommending for me, or might there be any conflicts?
4Given that this is an observational study collecting clinical, imaging, and genetic data over time, how long would I likely be followed, and what commitment would that realistically require from me over months or years?
5Are there any standard-of-care approaches for my specific vasculitis diagnosis that I should be pursuing first, and would participating in this study in any way delay or complicate getting those treatments?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To study the pathogenesis of patients affected with idiopathic systemic vasculitis, including clinical, radiographic, immunological, and genetic characteristics of the disease

Timeframe: end of study

Trial details

NCT IDNCT02257866

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

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2050-01-01

Contact for this trial

Shanni Liu

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

View on ClinicalTrials.gov More Takayasu's Arteritis trials

Plain-language summary