American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis

ClinicalTrials.gov ID: NCT01066208

Public ClinicalTrials.gov record NCT01066208. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

ACR/EULAR Endorsed Study to Develop New Diagnostic and Classification Criteria for Primary Systemic Vasculitis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Vasculitis is group of diseases where inflammation of blood vessels is the common feature. Patients typically present with fever, fatigue, weakness and muscle and joint aches. These symptoms are very common among many different diseases, not just vasculitis. A clustering of other symptoms, physical examination findings, blood tests, radiology and biopsy help make the diagnosis. There are currently no criteria to help doctors make a diagnosis of vasculitis when a patient presents with these non specific symptoms and they are reliant on previous experience and disease definitions. One of the aims of this project is to develop diagnostic criteria for the primary systemic vasculitides (granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis, Churg Strauss syndrome, polyarteritis nodosa, giant cell arteritis, Takayasu arteritis). We, the investigators, will do this by studying a large group of patients with vasculitis and comparing them to a large group of patients that present in a similar way, but do not have vasculitis. By comparing the 2 groups we will create a list of items to differentiate between vasculitis and 'vasculitis mimics'. We also aim to update the current classification criteria. Classification criteria are used to group patients into different types of vasculitis, once a diagnosis of vasculitis has been made, and are useful for studying patients in clinical trials with similar or identical diseases. The current classification criteria (American college of Rheumatology 1990 criteria) were developed 20 years ago, before the availability of some important diagnostic tests (e.g. antineutrophil cytoplasmic antibodies \[ANCA\]), and are now not consistent with some of the current disease definitions. Therefore to progress future research in vasculitis, it is important that the classification criteria are updated. We will recruit 260 patients with each of the 6 types of vasculitis and compare them with 1300 controls (patients with the 5 other types of vasculitis), in order to determine the optimal combination of symptoms, signs and investigations that classify each person into the appropriate group.

Study identification

NCT ID: NCT01066208
Recruitment status: Not listed
Study type: Observational
Phase: Not listed
Lead sponsor: University of Oxford; Other
Enrollment: 3,588 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 31, 2010
Primary completion: Nov 30, 2017
Completion: Nov 30, 2018
Last update posted: Aug 18, 2016

2011 – 2018

United States locations

U.S. sites: 14
U.S. states: 12
U.S. cities: 14

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham	Birmingham	Alabama	35233	Recruiting
Cedars-Sinai Medical Center, LA	Los Angeles	California	90048	Recruiting
University of California, San Francisco	San Francisco	California	94143-0500	Recruiting
University of Maryland	Baltimore	Maryland	21201	Recruiting
Vasculitis Center, Boston University School of Medicine	Boston	Massachusetts	02118	Recruiting
University of Michigan, Internal Medicine	Ann Arbor	Michigan	48109	Recruiting
Mayo Clinic	Rochester	Minnesota	55905	Recruiting
Dartmouth-Hitchcock Medical Centre, Lebanon, NH	Lebanon	New Hampshire	03756	Recruiting
New York University Langone Medical Centre	New York	New York	10016	Not yet recruiting
University of North Carolina	Chapel Hill	North Carolina	27599-7525	Not yet recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Recruiting
University of Pittsburgh	Pittsburgh	Pennsylvania	15261	Recruiting
University Medical Center	Salt Lake City	Utah	84132-0002	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 106 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01066208, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 18, 2016 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01066208 live on ClinicalTrials.gov.

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