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

• ClinicalTrials.gov Identifier: NCT01066208
• Recruitment Status: Unknown
• First Posted: February 10, 2010
• Last Update Posted: August 19, 2016
• Sponsor: University of Oxford
• Collaborators: American College of Rheumatology; The European League Against Rheumatism (EULAR); The Vasculitis foundation
• Information provided by (Responsible Party): University of Oxford

Study Description

Brief Summary:

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.

Condition or disease
Wegener's Granulomatosis; Microscopic Polyangiitis; Churg Strauss Syndrome; Polyarteritis Nodosa; Giant Cell Arteritis; Takayasu Arteritis

Detailed Description:

The systemic vasculitides are a group of uncommon but important diseases whose prognosis has improved dramatically with the use of immunosuppressive therapy. However, long-term morbidity from recurrent disease flares, low-grade grumbling disease and/or accumulating damage from previous disease activity or drug therapy now characterise the long-term outlook for patients with vasculitis. There remains major controversy, and incompatibility between the ANCA-associated vasculitides: granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis, and Churg Strauss Syndrome, as well as polyarteritis nodosa in the current classification criteria and disease definitions. Importantly, there are no diagnostic criteria for any of the primary systemic vasculitides.

We propose to improve existing classification criteria for the primary systemic vasculitides. As a starting point will include the following diseases: granulomatosis with polyangiitis (Wegener's) (GPA), microscopic polyangiitis (MPA), Churg Strauss syndrome (CSS), polyarteritis nodosa (PAN), giant cell arteritis (GCA) and Takayasu arteritis (TAK).

We propose to develop and validate classification and diagnostic criteria for primary systemic vasculitis using the guidelines suggested by the Classification and Response Criteria Subcommittee of the American College of Rheumatology Committee on Quality Measures. For all patients, a detailed medical history, physical examination, laboratory tests (including ANCA), radiology (including angiography), biopsy results, treatment, Birmingham Vasculitis Activity Score (BVAS)version 3, Vasculitis Damage Index (VDI), will be collected. The exact list of items to be recorded will be determined by the expert panel at the start of the study.

Classification criteria

We will study a minimum of 100 patients (new and existing patients) prospectively within each currently defined disease category (GPA, CSS, MPA, PAN, GCA, TAK) for the development of the classification criteria. We anticipate the need to recruit 130 patients to account for misdiagnosis and dropout to achieve the target of 100 with the confirmed reference diagnosis. This will include patients that have vasculitis which are assumed to be related to ANCA but do not fulfil the current definitions of any of the diseases, and patients with large vessel vasculitis which do not fulfil current definition for GCA or TAK. Therefore new categories of disease may be created as part of this process and some of the current disease categories may be changed to include or exclude certain patients.

The other diseases will be the controls. The same minimum number of patients will be used to validate the criteria. The 1st 100 patients with a formal reference diagnosis that are recruited for each disease will be used for development of the classification criteria; the next 100 consecutive patients recruited with a confirmed reference diagnosis for each disease will be used to validate the criteria. Again we anticipate the need to recruit 130 patients to account for misdiagnosis and dropout to achieve the 100 target. The majority of cases included will be the same as that used for the development of the diagnostic criteria.

In the absence of an established gold standard, we propose to develop a reference standard. Clinical vignettes using clustering of clinical features and investigations will be constructed from actual cases by the steering group. An expert panel will then be asked to classify each vignette. Hypothetical changes will then be made to components of each clinical vignette and the expert panel will be asked to re classify the case. This process will be repeated multiple times in an attempt to determine what key clinical feature influence the expert panel to change the diagnosis. Using this data driven process, a construct of important clinical features for each disease will be determined by the expert panel. Using this new construct, patients will be classified by the expert panel. This will form the reference standard against which the new criteria will be tested.

Diagnostic Criteria

We propose to develop and validate diagnostic criteria for primary systemic vasculitis. Based on current disease categories we will include GPA, MPA, CSS, PAN, GCA and TAK (but this may change depending on whether new categories are created or existing categories merged as part of the classification criteria component). For the development of diagnostic criteria, we will study a minimum of 100 patients (will require approx 130 patients to allow for dropout and misdiagnosis) for each disease category. Assuming 6 disease categories, the majority of these 780 patients will have already been identified from the classification criteria component of the study and will be re used for the development and validation of diagnostic criteria. However, for the diagnostic criteria to be clinically relevant we will only include patients that are seen at the time of 1st presentation, therefore not all the 780 patients recruited for the classification criteria section of the study will be suitable, and we will need to recruit additional new patients for each of the types of vasculitis being studied.

We will use a minimum of 400 context specific controls (patients that don't have vasculitis) for AAV and PAN that will cover the spectrum of different disease presentations and severity. In addition, we will recruit a minimum of 100 context specific controls for GCA and a similar number for TAK. Different control populations are needed for AAV, GCA and TAK as they have significantly different clinical presentations. In a similar manner to cases, we will recruit 30% more patients than the minimum required to account for misdiagnosis and drop out. The same minimum number of cases and controls will be needed to validate the criteria. The first half of the patients recruited would be used to develop the criteria, and the 2nd half to validate the criteria. We will allow inclusion of patients from previously studied prospective cohorts that meet all the appropriate inclusion / exclusion criteria and have had all the appropriate clinical information and mandatory investigation (to be defined later) recorded at time of their first presentation. This is to facilitate the recruitment of sufficient patients with PAN, CSS and TAK which are rare conditions.

Statistical analysis

We will follow the ACR recommended statistical methods for creating the classification criteria. Patients will have been classified into the different types of vasculitis according to the proposed EULAR/ACR schema by the expert panel or as a vasculitis mimic. The outcomes of interest are binary variables indicating whether or not a patient has been classified as having a particular type of vasculitis, such as GPA, MPA, etc. For each outcome, multivariable logistic regression modeling will be used to identify predictors of outcome based on the list of potential predictor variables described earlier. We will also explore the use of Classification And Regression Tree (CART) analysis. This is a tree-building technique ideally suited to the generation of clinical decision rules. Unlike conventional regression methods, patients are partitioned ("split") into different groups based on an exhaustive search of all possible predictor variables. The advantage of CART analysis over conventional methods is that it is non-parametric, so no assumptions are made about the underlying distribution of predictor variables. CART can handle many hundreds of possible predictor variables and can uncover complex interactions between predictors which may be difficult or impossible to uncover using traditional multivariate techniques that can suffer from model over fitting. In addition, clinicians generally do not think in terms of probability but rather in terms of categories, such as low versus high risk. Clinical decision rules generated using CART analysis are more likely to make clinical sense, and hence more likely to be followed in clinical practice.

Once the best items are identified, the expert panel will decide on the best short list of items to be included in each criteria and also choose the most appropriate decision tree. This will provide the best content validity.

The statistical methods to be used for diagnostic criteria will be very similar to that used for the classification criteria. The binary outcome for analysis is whether the person is a case or control (without vasculitis). We repeat the analyses for each of each type of vasculitis e.g. WG versus controls, then CSS versus controls etc

Study Design

• Study Type: Observational
• Estimated Enrollment: 3588 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: ACR/EULAR Endorsed Study to Develop New Diagnostic and Classification Criteria for Primary Systemic Vasculitis
• Study Start Date: January 2011
• Estimated Primary Completion Date: December 2017
• Estimated Study Completion Date: December 2018

Groups and Cohorts

Group/Cohort
WG classification; Patients with Wegener's granulomatosis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
MPA classification; Patients with microscopic polyangiitis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
CSS classification; Patients with Churg Strauss syndrome. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
PAN classification; Patients with polyarteritis nodosa. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
Control Classification; For each of the diseases being evaluated (WG, MPA, CSS, PAN, GCA, TAK), patients with the other 5 diseases will be the control group. Within these groups, 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
WG diagnostic; Patients with a new presentation of Wegener's granulomatosis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
MPA diagnostic; Patients with a new presentation of microscopic polyangiitis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
CSS diagnostic; Patients with a new presentation of Churg Strauss syndrome. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
PAN diagnostic; Patients with a new presentation of polyarteritis nodosa. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
Control diagnostic; Patients without vasculitis, but presenting with similar features to the 6 different types of vasculitis being studied. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
GCA classification; Patients with giant cell arteritis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
TAK classification; Patients with Takayasu arteritis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
GCA diagnostic; Patients with a new diagnosis of giant cell arteritis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
TAK diagnostic; Patients with a new diagnosis of Takayasu arteritis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.

Outcome Measures

Primary Outcome Measures :

1. Develop new diagnostic and classification criteria for ANCA associated vasculitis and polyarteritis nodosa [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA

Patients may be given the option of having blood, urine or other tissue obtained as part of their routine care retained for use in future ethically approved studies. They may also be asked to provide additional blood to be stored for this purpose. This component is an optional extra, and does not form part of the main study.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary systemic vasculitis or a mimic of these diseases seen in participating secondary or tertiary care centres in Europe, USA, Mexico, Japan, Asia, Australasia.

Criteria

Inclusion Criteria for Classification criteria:

1. Adult patients aged >18 years. There is no upper age limit.
2. Ability to give informed consent. If the patient is unable to give informed consent as a result of death or physical incapacity, then informed assent from next of kin.
3. Presumed diagnosis of a primary systemic vasculitis.

Exclusion criteria for classification criteria:

1. Patients < 18 years of age.
2. Inability to provide informed consent.
3. Hepatitis B or C
4. Co-morbidities that explain the clinical symptoms and signs on which the diagnosis of vasculitis is made. E.g. infection, tumour, other inflammatory condition, etc.

Inclusion criteria for diagnostic criteria:

1. Adult patients aged >18 years. There is no upper age limit.
2. Ability to give informed consent. If the patient is unable to give informed consent as a result of death or physical incapacity, then informed assent from next of kin.
3. Suspected diagnosis of a primary systemic vasculitis

Inclusion criteria for controls group for diagnostic criteria:

1. Adult patients aged >18 years. There is no upper age limit.
2. Ability to give informed consent. If the patient is unable to give informed consent as a result of death or physical incapacity, then informed assent from next of kin.
3. Patients presenting to secondary care with one of the following clinical presentations: I.Multi-system disease. Presentation of disease with at least 2 organs involved. II.Pulmonary-renal syndrome. Defined as haemoptysis / pulmonary haemorrhage with acute renal impairment. III.Acute renal failure IV.Acute respiratory distress. V.Chronic upper airways symptoms and signs. VI.Inflammatory polyarthritis. VII.Fever of unknown origin. VIII.Acute or chronic abdominal pain IX.Hypertension. X.Referred to secondary care with suspicion of vasculitis but confirmed not to have vasculitis. XII.New onset headache. XIII.Jaw or tongue pain. XIV.Sudden visual loss. XV.Limb claudication. XVI.Aortic aneurysm >5cm.

Exclusion Criteria for diagnostic criteria:

1. Patients under the age of 18
2. Patient or next of kin unable or unwilling to provide informed consent or assent.

Contacts and Locations

Contacts

Contact: Raashid A Luqmani; +44 1865 738106; raashid.luqmani@ndorms.ox.ac.uk

Contact: Anthea Craven; anthea.craven@ndorms.ox.ac.uk

Locations

United States, Alabama

University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35233

Contact: Angelo Gaffo agaffo@uab.edu

Principal Investigator: Angelo Gaffo

United States, California

Cedars-Sinai Medical Center, LA; Recruiting

Los Angeles, California, United States, 90048

Contact: Michael Weisman Weisman@cshs.org

Principal Investigator: Michael Weisman

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94143-0500

Contact: Sharon Chung sharon.chung@ucsf.edu

Principal Investigator: Sharon Chung

United States, Maryland

University of Maryland; Recruiting

Baltimore, Maryland, United States, 21201

Contact: Jamal Mikdashi jmikdash@umaryland.edu

Principal Investigator: Jamal Mikdashi

United States, Massachusetts

Vasculitis Center, Boston University School of Medicine; Recruiting

Boston, Massachusetts, United States, 02118

Contact: Peter Grayson peter.grayson@bmc.org

Principal Investigator: Peter Grayson

United States, Michigan

University of Michigan, Internal Medicine; Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: William J McCune jmccune@med.umich.edu

Contact: Ora Gewurz-Singer

Principal Investigator: Professor William J McCune

United States, Minnesota

Mayo Clinic; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Eric Matteson matteson.eric@mayo.edu

Principal Investigator: Eric Matteson

United States, New Hampshire

Dartmouth-Hitchcock Medical Centre, Lebanon, NH; Recruiting

Lebanon, New Hampshire, United States, 03756

Contact: Daniel A Albert Daniel.A.Albert@Hitchcock.ORG

Principal Investigator: Daniel A Albert

United States, New York

New York University Langone Medical Centre; Not yet recruiting

New York, New York, United States, 10016

Contact: Yusuf Yazici yusuf.yazici@nyumc.org

Principal Investigator: Yusuf Yazici

United States, North Carolina

University of North Carolina; Not yet recruiting

Chapel Hill, North Carolina, United States, 27599-7525

Contact: Charles Jennette jcj@med.unc.edu

Principal Investigator: Charles Jennette

Principal Investigator: Ronald Falk

United States, Ohio

Cleveland Clinic; Recruiting

Cleveland, Ohio, United States, 44195

Contact: Carol Langford LANGFOC@ccf.org

Principal Investigator: Leonard Calabrese

United States, Pennsylvania

University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Peter A Merkel pmerkel@upenn.edu

Principal Investigator: Peter A Merkel

University of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15261

Contact: Kim Liang liangkp@upmc.edu

Principal Investigator: Kim Liang

United States, Utah

University Medical Center; Not yet recruiting

Salt Lake City, Utah, United States, 84132-0002

Contact: Curry Koening curry.koening@hsc.utah.edu

Principal Investigator: Curry Koening

Argentina

Hospital Interzonal San Juan Bautista; Recruiting

San Fernando del Valle de Catamarca, Catamarca, Argentina

Contact: Sergio Toloza sergiotol@yahoo.com

Principal Investigator: Sergio Toloza

Ramos Mejia Hospital, University of Buenos Aires; Recruiting

Buenos Aires, Argentina, C1221ADC

Contact: Eduardo Kerzberg eduardomariok@gmail.com

Principal Investigator: Eduardo Kerzberg

Australia, Australian Capital Territory

ANU Medical Centre; Recruiting

Canberra, Australian Capital Territory, Australia

Contact: Paul Gatenby paul-gatenby@anu.edu.au

Principal Investigator: Paul Gatenby

Australia, Queensland

Royal Brisbane and Women's Hospital; Recruiting

Herston, Queensland, Australia, 4029

Contact: Dwarakanathan Ranganathan Dwarakanathan_Ranganathan@health.qld.gov.au

Principal Investigator: Dwarakanathan Ranganathan

Austria

Medical University Innsbruck; Recruiting

Innsbruck, Austria

Contact: Andreas Kronbichler Andreas.Kronbichler@i-med.ac.at

Principal Investigator: Andreas Kronbichler

Belgium

University Hospitals Leuven; Recruiting

Leuven, Belgium

Contact: Daniel Blockmans Daniel.Blockmans@uz.kuleuven.ac.be

Principal Investigator: Daniel Blockmans

Canada, Manitoba

University of Manitoba; Recruiting

Winnipeg, Manitoba, Canada, R3A 1M4

Contact: Navjot Dhindsa ndhindsa@hsc.mb.ca

Principal Investigator: Navjot Dhindsa

Canada, Ontario

St Joseph's Healthcare; Recruiting

Hamilton, Ontario, Canada

Contact: Nader Khalidi naderkhalidi@sympatico.ca

Principal Investigator: Nader Khalidi

University of Ottawa; Recruiting

Ottawa, Ontario, Canada, K1N 6N5

Contact: Nataliya Milman nmilman@Ottawahospital.on.ca

Principal Investigator: Nataliya Milman

Mount Sinai Hospital, Toronto; Recruiting

Toronto, Ontario, Canada, ON M5T 2S8

Contact: Simon Carette Simon.Carette@uhn.on.ca

Principal Investigator: Simon Carette

Canada, Quebec

McGill University; Recruiting

Montreal, Quebec, Canada, H3A 0G4

Contact: Christian Pineau christian.pineau@mcgill.ca

Principal Investigator: Christian Pineau

Sherbrooke University Hospital Centre; Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contact: Patrick Liang patrick.liang@usherbrooke.ca

Principal Investigator: Patrick Liang

Canada

University of Calgary; Not yet recruiting

Calgary, Canada

Contact: Michael Walsh mwwalsh@ucalgary.ca

Principal Investigator: Michael Walsh

St Joseph's Healthcare London, Ontario; Recruiting

Ontario, Canada

Contact: Lillian Barra

Principal Investigator: Lillian Barra

China

Peking Union Medical College Hospital, Beijing; Recruiting

Beijing, China, 100032

Contact: Xinping Tian tianxp6@126.com

Principal Investigator: Xinping Tian

Czech Republic

General University Hospital, Prague; Recruiting

Prague, Czech Republic, 128 08

Contact: Vladimir Tesar vladimir.tesar@lf1.cuni.cz

Principal Investigator: Vladimir Tesar

General University Hospital; Recruiting

Prague, Czech Republic

Contact: Vladamir Tesar

Principal Investigator: Vladamir Tesar

Denmark

Rigshospitalet; Recruiting

Copenhagen, Denmark

Contact: Neils Rasmussen nrasent@dadlnet.dk

Principal Investigator: Niels Rasmussen

Principal Investigator: Bo Baslund

Egypt

Assiut University, Assiut University Hospitals; Recruiting

Assiut, Egypt, 71516

Contact: Nevin Hammam nevin.hammam@gmail.com

Principal Investigator: Nevin Hammam

Cairo University, Kasr El Ainy Hospital; Recruiting

Cairo, Egypt

Contact: Amira Shahin amirashahin@hotmail.com

Principal Investigator: Amira Shahin

Finland

Helsinki University Central Hospital; Recruiting

Helsinki, Finland

Contact: Jukka Putaala jukka.putaala@hus.fi

Principal Investigator: Jukka Putaala

France

Cochin Hospital, Université Paris-descartes; Not yet recruiting

Paris, France, 75679

Contact: Loic Guillevin loic.guillevin@wanadoo.fr

Principal Investigator: Loic Guillevin

Germany

Universitätsklinikum Jena; Recruiting

Jena, Germany, 07743 Jena

Contact: Thomas Neumann Thomas.Neumann@med.uni-jena.de

Principal Investigator: Thomas Neumann

University of Schleswig-Holstein; Recruiting

Luebeck, Germany

Contact: Julia Holle hollejulia@hotmail.com

Principal Investigator: Julia Holle

Universitätsklinikum Münster; Recruiting

Münster, Germany, 48149

Contact: Cord Sunderkötter Cord.Sunderkoetter@ukmuenster.de

Principal Investigator: Cord Sunderkötter

Kreiskliniken Esslingen; Recruiting

Plochingen, Germany, 73207

Contact: Bernhard Hellmich b.hellmich@kk-es.de

Principal Investigator: Bernhard Hellmich

University Hospital Tübingen; Recruiting

Tübingen, Germany, D-72076

Contact: Joerg Henes joerg.henes@med.uni-tuebingen.de

Principal Investigator: Joerg Henes

Hungary

University of Debrecen Medical and Health Science Center; Recruiting

Debrecen, Hungary, 4032

Contact: Zoltan Szekanecz szekanecz.zoltan@med.unideb.hu

Principal Investigator: Zoltan Szekanecz

India

Chatrapathi Shahuji Maharaj Medical Center, Lucknow (IProcess); Recruiting

Lucknow, Uttar Pradesh, India, 226003

Contact: Siddhart Das

Principal Investigator: Siddhart Das

Postgraduate Institute of Medical Education and Research, Chandigarh; Recruiting

Chandigarh, India, Pin- 160 012

Contact: Aman Sharma pgimer-chd@nic.in

Principal Investigator: Aman Sharma

Nizam's Institute of Medical Sciences, Hyderabad; Recruiting

Hyderabad, India, 500082

Contact: Liza Rajasekhar lizarajasekhar@gmail.com

Principal Investigator: Liza Rajasekhar

Medanta, Delhi; Recruiting

New Delhi, India, 110024

Contact: Rajiva Gupta guptarajiva@hotmail.com

Principal Investigator: Rajiva Gupta

Christian Medical College & Hospital, Vellore; Recruiting

Vellore, India, 632 004

Contact: Debashish Danda debashish.danda@cmcvellore.ac.in

Principal Investigator: Debashish Danda

Ireland

Cork University Hospital; Recruiting

Cork, Ireland

Contact: Michael Clarkson michael.clarkson@hse.ie

Principal Investigator: Michael Clarkson

St. Vincent's University Hospital, Dublin; Recruiting

Dublin 4, Ireland

Contact: Eamonn Molloy E.Molloy@st-vincents.ie

Principal Investigator: Eamonn Molloy

Italy

University of Parma; Recruiting

Parma, Italy

Contact: Augusto Vaglio augusto.vaglio@virgilio.it

Principal Investigator: Augusto Vaglio

Santa Maria Nuova Hospital, Reggio Emilia; Recruiting

Reggio Emilia, Italy, 42123

Contact: Carlo Salvarani Carlo.Salvarani@asmn.re.it

Principal Investigator: Carlo Salvarani

Arcispedale Santa Maria Nuova; Recruiting

Reggio Emilia, Italy

Contact: Carlo Salvarani Carlo.Salvarani@asmn.re.it

Principal Investigator: Carlo Salvarani

Japan

Kameda Medical Centre, Kamogawa; Recruiting

Kamogawa City, Chiba prefecture, Japan, 296-8602

Contact: Kazuo Matsui pxu17054@nifty.com

Principal Investigator: Kazuo Matsui

Tsukuba University Hospital; Recruiting

Tsukuba, Ibaraki Prefecture, Japan, 305-8576

Contact: Kunihiro Yamagata

Principal Investigator: Kunihiro Yamagata

Miyazaki University Hospital; Recruiting

Miyazaki City, Miyazaki Prefecture, Japan, 889-1692

Contact: Shouichi Fujimoto

Principal Investigator: Shouichi Fujimoto

Saitama Medical University; Recruiting

Kawagoe, Saitama Prefecture, Japan, 350-8550

Contact: Koichi Amano amanokoi@saitama-med.ac.jp

Principal Investigator: Koichi Amano

Kyorin University Hospital; Recruiting

Mitaka, Tokyo Prefecture, Japan, 181-8611

Contact: Yoshihiro Arimura

Principal Investigator: Yoshihiro Arimura

Chiba University; Recruiting

Chiba, Japan, 260-8670

Contact: Kazuo Suzuki ksuzuki@faculty.chiba-u.jp

Principal Investigator: Kazuo Suzuki

Kagawa University Hospital; Recruiting

Kagawa, Japan, 761-0793

Contact: Hiroaki Dobashi

Principal Investigator: Hiroaki Dobashi

St. Marianna University Hospital; Recruiting

Kanagawa, Japan, 216-8511

Contact: Hidehiro Yamada guriko@marianna-u.ac.jp

Principal Investigator: Hidehiro Yamada

Kanazawa University Hospital; Recruiting

Kanazawa, Japan, 920-8641

Contact: Takashi Wada twada@medf.m.kanazawa-u.ac.jp

Principal Investigator: Takashi Wada

Okayama University Hospital; Recruiting

Okayama, Japan, 700-8558

Contact: Hirofumi Makino

Principal Investigator: Hirofumi Makino

Kitano Hospital; Recruiting

Osaka, Japan

Contact: Eri Muso

Principal Investigator: Eri Muso

Juntendo University Koshigaya Hospital; Recruiting

Saitama, Japan, 343-0032

Contact: Shigeto Kobayashi

Principal Investigator: Shigeto Kobayashi

Jichi Medical University Hospital; Recruiting

Tochigi-ken, Japan, 3311-1 Yakushiji

Contact: Wako Yumura

Principal Investigator: Wako Yumura

University Tokyo Hospital; Recruiting

Tokyo, Japan, 113-8655

Contact: Junichi Hirahashi jhirahashi-tky@umin.ac.jp

Principal Investigator: Junichi Hirahashi

Korea, Republic of

Seoul National University Hospital; Recruiting

Seoul, Korea, Republic of, 110-744

Contact: Yeong-Wook Song ysong@snu.ac.kr

Principal Investigator: Yeong-Wook Song

Mexico

Instituto Nacional de Enfermedades Respiratorias; Recruiting

Mexico City, Mexico, 14000

Contact: Luis Felipe Flores-Suárez felipe98@prodigy.net.mx

Principal Investigator: Luis Felipe Flores-Suárez

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Recruiting

Mexico City, Mexico

Contact: Andrea Hinojosa

Principal Investigator: Andrea Hinojosa

Netherlands

VU University Medical Center; Not yet recruiting

Amsterdam, Netherlands, 6Z 165

Contact: Maarten Boers mboers56@xs4all.nl

Principal Investigator: Maarten Boers

University Medical Center Groningen; Recruiting

Groningen, Netherlands, 30.001

Contact: Abraham Rutgers a.rutgers@umgc.nl

Principal Investigator: Abraham Rutgers

New Zealand

University of Otago, Christchurch; Recruiting

Christchurch, Canterbury, New Zealand, 8011

Contact: Lisa Stamp Lisa.Stamp@cdhb.govt.nz

Principal Investigator: Lisa Stamp

Auckland District Health Board; Recruiting

Auckland, New Zealand

Contact: Ravi Suppiah

Principal Investigator: Ravi Suppiah

Waitemata District Health Board, North Shore Hospital; Not yet recruiting

Auckland, New Zealand

Contact: Janak de Zoysa janak.dezoysa@waitematadhb.govt.nz

Principal Investigator: Janak de Zoysa

Waikato District Health Board; Recruiting

Hamilton, New Zealand, 3240

Contact: Vicky Quincey vicki.quincey@waikatodhb.health.nz

Principal Investigator: Vicky Quincey

Norway

Hospital of Southern Norway; Recruiting

Kristiansand, Norway, Post box 416, 4605

Contact: Andreas Diamantopoulos +47 38073155 andreas.diamantopoulos@sshf.no

Principal Investigator: Andreas Diamantopoulos

The University Hospital of Northern Norway, Tromsø; Recruiting

Tromsø, Norway, 9038

Contact: Emilio Besada Emilio.Besada@unn.no

Principal Investigator: Emilio Besada

Poland

University of Jagiellonian; Recruiting

Kraków, Poland, 31-007

Contact: Jan Sznajd jsznajd@gmail.com

Principal Investigator: Jan Sznajd

Portugal

Hospital Garcia de Orta, Almada; Recruiting

Almada, Portugal

Contact: Miguel Rodrigues mig.rodrigues69@gmail.com

Principal Investigator: Miguel Rodrigues

Santa Maria Hospital, Lisbon; Recruiting

Lisbon, Portugal, 1649-035

Contact: Ruth Geraldes ruth.geraldes@netcabo.pt

Principal Investigator: Ruth Geraldes

Hospital Santo Antonio, Porto; Recruiting

Porto, Portugal, 4099 - 001

Contact: Ernestina Santos ernestina.santos@gmail.com

Principal Investigator: Ernestina Santos

Russian Federation

First Moscow State Medical University; Recruiting

Moscow, Russian Federation, 119991

Contact: Sergey Moiseev clinpharm@mtu-net.ru

Principal Investigator: Sergey Moiseev

Sub-Investigator: Pavel Novikov

Slovenia

University Medical Centre Ljubljana; Recruiting

Ljubljana, Slovenia, 1000

Contact: Alojzija Hočevar alojzija.hocevar@siol.net

Principal Investigator: Alojzija Hočevar

Spain

Clinic Barcelona Hospital Universitari; Recruiting

Barcelona, Catalonia, Spain

Contact: Maria Cid MCCID@clinic.ub.es

Principal Investigator: Maria Cid

Sri Lanka

University of Colombo; Recruiting

Columbo 8, Sri Lanka

Contact: Inoshi Atukorala inoshi.atu@gmail.com

Principal Investigator: Inoshi Atukorala

Sweden

Lund University; Recruiting

Lund, Sweden, SE-221 85

Contact: Aladdin Mohammad aladdin.mohammad@med.lu.se

Principal Investigator: Mårten Segelmark

Karolinska Institute, Stockholm; Not yet recruiting

Stockholm, Sweden, 141 86

Contact: Johan Bratt johan.bratt@karolinska.se

Principal Investigator: Johan Bratt

Linköping University; Recruiting

Stockholm, Sweden, 581 83

Contact: Marten Segelmark marten.segelmark@liu.se

Principal Investigator: Marten Segelmark

Umeå University; Not yet recruiting

Umeå, Sweden, 901 85

Contact: Ewa Berglin ewa.berglin@vll.se

Principal Investigator: Ewa Berglin

Uppsala University Hospital; Not yet recruiting

Uppsala, Sweden, 751 85

Contact: Ann Knight ann.kataja.knight@akademiska.se

Principal Investigator: Ann Knight

Switzerland

University Hospital Basel; Recruiting

Basel, Switzerland, 4031

Contact: Thomas Daikeler tdaikeler@uhvs.ch

Principal Investigator: Thomas Daikeler

Immunologie-Zentrum Zurich; Not yet recruiting

Zurich, Switzerland

Contact: Thomas Hauser hauser@immunologie-zentrum.ch

Principal Investigator: Thomas Hauser

Turkey

Hacettepe University; Recruiting

Ankara, Turkey

Contact: Omer Karadag omerkaradag@ymail.com

Principal Investigator: Omer Karadag

Istanbul University, Cerrahpasa Medical School; Recruiting

Istanbul, Turkey, 34098

Contact: Gulen Hatemi gulen.hatemi@yahoo.com

Principal Investigator: Gulen Hatemi

Marmara University Medical School; Recruiting

Istanbul, Turkey, 34668

Contact: Haner Direskeneli hanerdireskeneli@gmail.com

Principal Investigator: Haner Direskeneli

Fatih University Medical Faculty; Recruiting

Istanbul, Turkey, 34844

Contact: Seval Pehlivan sevalpehlevan@gmail.com

Principal Investigator: Seval Pehlivan

Haydarpasa Education and Research Hospital; Not yet recruiting

Istanbul, Turkey

Contact: Hasan Yazici hyazici@attglobal.net

Principal Investigator: Hasan Yazici

Istanbul University, Istanbul Medical School; Recruiting

Istanbul, Turkey

Contact: Sevil Kamali sevilkamali@hotmail.com

Principal Investigator: Sevil Kamali

United Kingdom

North Cumbria University Hospitals, The Cumberland Infirmary; Recruiting

Carlisle, Cumbria, United Kingdom, CA2 7HY

Contact: Alaa Hassan Alaa.Hassan@ncuh.nhs.uk

Principal Investigator: Alaa Hassan

Basildon and Thurrock University Hospitals NHS Foundation Trust; Recruiting

Basildon, Essex, United Kingdom, SS16 5NL

Contact: Nagui Gendi

Principal Investigator: Nagui Gendi

Queen's Hospital; Recruiting

Romford, Essex, United Kingdom, RM7 0AG

Contact: Kuntal Chakravarty kuntal@talk21.com

Principal Investigator: Kuntal Chakravarty

Southend University Hospital NHS Trust; Recruiting

Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY

Contact: Bhaskar Dasgupta Bhaskar.Dasgupta@southend.nhs.uk

Principal Investigator: Bhaskar Dasgupta

NHS Fife, Whyteman's Brae Hospital, Windygates; Recruiting

Kirkcaldy, Fife, United Kingdom, KY8 5PR

Contact: John Mclaren john.mclaren2@nhs.net

Principal Investigator: John Mclaren

Aberdeen Royal Infirmary; Recruiting

Aberdeen, Scotland, United Kingdom, AB25 2ZN

Contact: Neil Basu neilbasu@nhs.net

Principal Investigator: Neil Basu

NHS Greater Glasgow & Clyde, Gartnavel Hospital; Recruiting

Glasgow, Scotland, United Kingdom, G12 8TA

Contact: Iain McInnes iain.mcinnes@glasgow.ac.uk

Principal Investigator: Iain McInnes

Ipswich Hospital NHS Trust; Recruiting

Ipswich, Suffolk, United Kingdom

Contact: Richard Watts richard.watts2@mac.com

Principal Investigator: Professor Richard Watts

Epsom and St Helier University Hospitals NHS Trust; Recruiting

Carshalton, Surrey, United Kingdom, SM5 1AA

Contact: Sanjeev Patel

Contact: Ritu Malaiya ritumalaiya@doctors.org.uk

Principal Investigator: Sanjeev Patel

University of Birmingham; Recruiting

Birmingham, United Kingdom

Contact: Matthew Morgan m.d.morgan@bham.ac.uk

Principal Investigator: Caroline Savage

Addenbrooke's Hospital; Recruiting

Cambridge, United Kingdom

Contact: David Jayne david.jayne@addenbrookes.nhs.uk

Principal Investigator: David Jayne

Dudley Group of Hospitals, NHS FT; Recruiting

Dudley, United Kingdom, DY1 2HQ

Contact: Rainer Kloche 0044 1384 244807

Principal Investigator: Rainer Kloche

Imperial College Healthcare NHS Trust, Hammersmith Hospital; Recruiting

London, United Kingdom, W12 0HS

Contact: Justin Mason justin.mason@imperial.ac.uk

Principal Investigator: Justin Mason

University of Manchester, Manchester Royal Infirmary; Recruiting

Manchester, United Kingdom, M13 9WL

Contact: Ian Bruce ian.bruce@manchester.ac.uk

Principal Investigator: Ian Bruce

Norfolk and Norwich University Hospital; Recruiting

Norwich, United Kingdom, NR4 7UY

Contact: Laura Harper LAURA.HARPER@nnuh.nhs.uk

Principal Investigator: Chetan Mukhtyar

Nottingham University Hospitals NHS Trust (QMC); Recruiting

Nottingham, United Kingdom, NG7 2UH

Contact: Peter Lanyon Peter.Lanyon@nuh.nhs.uk

Principal Investigator: Peter Lanyon

Nuffield Orthopaedic Centre; Recruiting

Oxford, United Kingdom, OX3 7LD

Contact: Raashid Luqmani raashid.luqmani@noc.nhs.uk

Principal Investigator: Raashid Luqmani

Sub-Investigator: Joanna Robson

Oxford University Hospitals NHS Trust (The Churchill Hospital); Recruiting

Oxford, United Kingdom, OX3 7LE

Contact: Rachel Hoyles rachel.hoyles@ouht.nhs.uk

Principal Investigator: Rachel Hoyles

Royal Berkshire NHS Trust; Recruiting

Reading, United Kingdom, RG1 5AN

Contact: Oliver Flossmann 0118 3225308 oliver.flossman@royalberkshire.nhs.uk

Principal Investigator: Oliver Flossmann

Heatherwood & Wexham Park Hospitals NHS Foundation Trust; Recruiting

Slough, United Kingdom, SL2 4HL

Contact: Matthew Adler Matthew.Adler@hwph-tr.nhs.uk

Principal Investigator: Matthew Adler

Southampton University Hospitals NHS Trust; Withdrawn

Southampton, United Kingdom, SO16 6YD

York Hospital NHS Foundation Trust; Recruiting

York, United Kingdom, YO31 8HE

Contact: Colin Jones Colin.H.Jones@York.NHS.UK

Principal Investigator: Colin Jones

Sponsors and Collaborators

University of Oxford

American College of Rheumatology

The European League Against Rheumatism (EULAR)

The Vasculitis foundation

Investigators

• Principal Investigator: Raashid A Luqmani, DM, FRCP(E); University of Oxford, United Kingdom
• Principal Investigator: Peter Merkel, MD, MPH; University of Pennsylvania
• Principal Investigator: Richard Watts, DM, FRCP; University of East Anglia

More Information

Additional Information:

Website for European Vasculitis Study Group (EUVAS) 

Publications:

Singh JA, Solomon DH, Dougados M, Felson D, Hawker G, Katz P, Paulus H, Wallace C; Classification and Response Criteria Subcommittee of the Committee on Quality Measures, American College of Rheumatology. Development of classification and response criteria for rheumatic diseases. Arthritis Rheum. 2006 Jun 15;55(3):348-52. doi: 10.1002/art.22003.

Rao JK, Allen NB, Pincus T. Limitations of the 1990 American College of Rheumatology classification criteria in the diagnosis of vasculitis. Ann Intern Med. 1998 Sep 1;129(5):345-52. doi: 10.7326/0003-4819-129-5-199809010-00001.

Hunder GG, Arend WP, Bloch DA, Calabrese LH, Fauci AS, Fries JF, Leavitt RY, Lie JT, Lightfoot RW Jr, Masi AT, et al. The American College of Rheumatology 1990 criteria for the classification of vasculitis. Introduction. Arthritis Rheum. 1990 Aug;33(8):1065-7. doi: 10.1002/art.1780330802. No abstract available.

Fries JF, Hunder GG, Bloch DA, Michel BA, Arend WP, Calabrese LH, Fauci AS, Leavitt RY, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of vasculitis. Summary. Arthritis Rheum. 1990 Aug;33(8):1135-6. doi: 10.1002/art.1780330812. No abstract available.

Jennette JC, Falk RJ, Andrassy K, Bacon PA, Churg J, Gross WL, Hagen EC, Hoffman GS, Hunder GG, Kallenberg CG, et al. Nomenclature of systemic vasculitides. Proposal of an international consensus conference. Arthritis Rheum. 1994 Feb;37(2):187-92. doi: 10.1002/art.1780370206.

Sorensen SF, Slot O, Tvede N, Petersen J. A prospective study of vasculitis patients collected in a five year period: evaluation of the Chapel Hill nomenclature. Ann Rheum Dis. 2000 Jun;59(6):478-82. doi: 10.1136/ard.59.6.478.

Felson DT, Anderson JJ. Methodological and statistical approaches to criteria development in rheumatic diseases. Baillieres Clin Rheumatol. 1995 May;9(2):253-66. doi: 10.1016/s0950-3579(05)80189-x.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yates M, MacGregor AJ, Robson J, Craven A, Merkel PA, Luqmani RA, Watts RA. The association of vascular risk factors with visual loss in giant cell arteritis. Rheumatology (Oxford). 2017 Apr 1;56(4):524-528. doi: 10.1093/rheumatology/kew397.

• Responsible Party: University of Oxford
• ClinicalTrials.gov Identifier: NCT01066208
• Other Study ID Numbers: ACREULAR001
• First Posted: February 10, 2010
• Last Update Posted: August 19, 2016
• Last Verified: August 2016

Keywords provided by University of Oxford:

Classification criteria; Diagnostic criteria

Additional relevant MeSH terms:

Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Vasculitis; Systemic Vasculitis; Vasculitis, Central Nervous System; Rheumatic Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis; Takayasu Arteritis; Aortic Arch Syndromes; Churg-Strauss Syndrome; Polyarteritis Nodosa; Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Skin Diseases, Vascular; Skin Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Lung Diseases, Interstitial; Lung Diseases