Wegener's GranulomatosisDCVASNCT01066208
American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis
An observational study of Wegener's Granulomatosis and Microscopic Polyangiitis, run by University of Oxford at 120 sites in 33 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wegener's Granulomatosis, Microscopic Polyangiitis, Churg Strauss Syndrome
- How many people
- 3,588 participants
- Where
- 120 sitesin 33 countries
- Study dates
- Jan 2011to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients aged >18 years. There is no upper age limit.
- 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.
- Presumed diagnosis of a primary systemic vasculitis.
- Adult patients aged >18 years. There is no upper age limit.
- 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.
- Suspected diagnosis of a primary systemic vasculitis
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- Inclusion criteria for controls group for diagnostic criteria:
- Adult patients aged >18 years. There is no upper age limit.
- 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.
- 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.
Who cannot join
- Patients < 18 years of age.
- Inability to provide informed consent.
- Hepatitis B or C
- 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.
- Patients under the age of 18
- Patient or next of kin unable or unwilling to provide informed consent or assent.
Trial locations and contacts
120 sites in 33 countries.
Anthea Craven contact
120 sites in 33 countries
United Kingdom22 sites, 21 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Neil Basu, neilbasu@nhs.net
Neil Basu
- Recruiting
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, Essex, SS16 5NL
Nagui Gendi
Nagui Gendi
- Recruiting
University of Birmingham
Birmingham
Matthew Morgan, m.d.morgan@bham.ac.uk
Caroline Savage
- Recruiting
Addenbrooke's Hospital
Cambridge
David Jayne, david.jayne@addenbrookes.nhs.uk
David Jayne
- Recruiting
North Cumbria University Hospitals, The Cumberland Infirmary
Carlisle, Cumbria, CA2 7HY
Alaa Hassan, Alaa.Hassan@ncuh.nhs.uk
Alaa Hassan
- Recruiting
Epsom and St Helier University Hospitals NHS Trust
Carshalton, Surrey, SM5 1AA
Sanjeev Patel
Ritu Malaiya, ritumalaiya@doctors.org.uk
- Recruiting
Dudley Group of Hospitals, NHS FT
Dudley, DY1 2HQ
Rainer Kloche, 0044 1384 244807
Rainer Kloche
- Recruiting
NHS Greater Glasgow & Clyde, Gartnavel Hospital
Glasgow, Scotland, G12 8TA
Iain McInnes, iain.mcinnes@glasgow.ac.uk
Iain McInnes
- Recruiting
Ipswich Hospital NHS Trust
Ipswich, Suffolk
Richard Watts, richard.watts2@mac.com
Professor Richard Watts
- Recruiting
NHS Fife, Whyteman's Brae Hospital, Windygates
Kirkcaldy, Fife, KY8 5PR
John Mclaren, john.mclaren2@nhs.net
John Mclaren
- Recruiting
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London, W12 0HS
Justin Mason, justin.mason@imperial.ac.uk
Justin Mason
- Recruiting
University of Manchester, Manchester Royal Infirmary
Manchester, M13 9WL
Ian Bruce, ian.bruce@manchester.ac.uk
Ian Bruce
- Recruiting
Norfolk and Norwich University Hospital
Norwich, Norwich, NR4 7UY
Laura Harper, LAURA.HARPER@nnuh.nhs.uk
Chetan Mukhtyar
- Recruiting
Nottingham University Hospitals NHS Trust (QMC)
Nottingham, NG7 2UH
Peter Lanyon, Peter.Lanyon@nuh.nhs.uk
Peter Lanyon
- Recruiting
Nuffield Orthopaedic Centre
Oxford, Oxford, OX3 7LD
Raashid Luqmani, raashid.luqmani@noc.nhs.uk
Raashid Luqmani
- Recruiting
Oxford University Hospitals NHS Trust (The Churchill Hospital)
Oxford, OX3 7LE
Rachel Hoyles, rachel.hoyles@ouht.nhs.uk
Rachel Hoyles
- Recruiting
Royal Berkshire NHS Trust
Reading, RG1 5AN
Oliver Flossmann, 0118 3225308, oliver.flossman@royalberkshire.nhs.uk
Oliver Flossmann
- Recruiting
Queen's Hospital
Romford, Essex, RM7 0AG
Kuntal Chakravarty, kuntal@talk21.com
Kuntal Chakravarty
- Recruiting
Heatherwood & Wexham Park Hospitals NHS Foundation Trust
Slough, SL2 4HL
Matthew Adler, Matthew.Adler@hwph-tr.nhs.uk
Matthew Adler
- Withdrawn
Southampton University Hospitals NHS Trust
Southampton, SO16 6YD
- Recruiting
Southend University Hospital NHS Trust
Westcliff-on-Sea, Essex, SS0 0RY
Bhaskar Dasgupta, Bhaskar.Dasgupta@southend.nhs.uk
Bhaskar Dasgupta
- Recruiting
York Hospital NHS Foundation Trust
York, YO31 8HE
Colin Jones, Colin.H.Jones@York.NHS.UK
Colin Jones
United States14 sites, 14 recruiting
- Recruiting
University of Michigan, Internal Medicine
Ann Arbor, Michigan, 48109
William J McCune, jmccune@med.umich.edu
Ora Gewurz-Singer
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Jamal Mikdashi, jmikdash@umaryland.edu
Jamal Mikdashi
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Angelo Gaffo, agaffo@uab.edu
Angelo Gaffo
- Recruiting
Vasculitis Center, Boston University School of Medicine
Boston, Massachusetts, 02118
Peter Grayson, peter.grayson@bmc.org
Peter Grayson
- Not yet recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599-7525
Charles Jennette, jcj@med.unc.edu
Charles Jennette
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Carol Langford, LANGFOC@ccf.org
Leonard Calabrese
- Recruiting
Dartmouth-Hitchcock Medical Centre, Lebanon, NH
Lebanon, New Hampshire, 03756
Daniel A Albert, Daniel.A.Albert@Hitchcock.ORG
Daniel A Albert
- Recruiting
Cedars-Sinai Medical Center, LA
Los Angeles, California, 90048
Michael Weisman, Weisman@cshs.org
Michael Weisman
- Not yet recruiting
New York University Langone Medical Centre
New York, New York, 10016
Yusuf Yazici, yusuf.yazici@nyumc.org
Yusuf Yazici
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Peter A Merkel, pmerkel@upenn.edu
Peter A Merkel
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Kim Liang, liangkp@upmc.edu
Kim Liang
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Eric Matteson, matteson.eric@mayo.edu
Eric Matteson
- Not yet recruiting
University Medical Center
Salt Lake City, Utah, 84132-0002
Curry Koening, curry.koening@hsc.utah.edu
Curry Koening
- Recruiting
University of California, San Francisco
San Francisco, California, 94143-0500
Sharon Chung, sharon.chung@ucsf.edu
Sharon Chung
Japan14 sites, 14 recruiting
- Recruiting
Chiba University
Chiba, 260-8670
Kazuo Suzuki, ksuzuki@faculty.chiba-u.jp
Kazuo Suzuki
- Recruiting
Kagawa University Hospital
Kagawa, 761-0793
Hiroaki Dobashi
Hiroaki Dobashi
- Recruiting
Kameda Medical Centre, Kamogawa
Kamogawa, Chiba, 296-8602
Kazuo Matsui, pxu17054@nifty.com
Kazuo Matsui
- Recruiting
St. Marianna University Hospital
Kanagawa, 216-8511
Hidehiro Yamada, guriko@marianna-u.ac.jp
Hidehiro Yamada
- Recruiting
Kanazawa University Hospital
Kanazawa, 920-8641
Takashi Wada, twada@medf.m.kanazawa-u.ac.jp
Takashi Wada
- Recruiting
Saitama Medical University
Kawagoe, Saitama, 350-8550
Koichi Amano, amanokoi@saitama-med.ac.jp
Koichi Amano
- Recruiting
Kyorin University Hospital
Mitaka, Tokyo, 181-8611
Yoshihiro Arimura
Yoshihiro Arimura
- Recruiting
Miyazaki University Hospital
Miyazaki, Miyazaki, 889-1692
Shouichi Fujimoto
Shouichi Fujimoto
- Recruiting
Okayama University Hospital
Okayama, 700-8558
Hirofumi Makino
Hirofumi Makino
- Recruiting
Kitano Hospital
Osaka
Eri Muso
Eri Muso
- Recruiting
Juntendo University Koshigaya Hospital
Saitama, 343-0032
Shigeto Kobayashi
Shigeto Kobayashi
- Recruiting
Jichi Medical University Hospital
Tochigi-ken, 3311-1 Yakushiji
Wako Yumura
Wako Yumura
- Recruiting
University Tokyo Hospital
Tokyo, 113-8655
Junichi Hirahashi, jhirahashi-tky@umin.ac.jp
Junichi Hirahashi
- Recruiting
Tsukuba University Hospital
Tsukuba, Ibaraki, 305-8576
Kunihiro Yamagata
Kunihiro Yamagata
Canada8 sites, 8 recruiting
- Not yet recruiting
University of Calgary
Calgary
Michael Walsh, mwwalsh@ucalgary.ca
Michael Walsh
- Recruiting
St Joseph's Healthcare
Hamilton, Ontario
Nader Khalidi, naderkhalidi@sympatico.ca
Nader Khalidi
- Recruiting
McGill University
Montreal, Quebec, H3A 0G4
Christian Pineau, christian.pineau@mcgill.ca
Christian Pineau
- Recruiting
St Joseph's Healthcare London, Ontario
Ontario
Lillian Barra
Lillian Barra
- Recruiting
University of Ottawa
Ottawa, Ontario, K1N 6N5
Nataliya Milman, nmilman@Ottawahospital.on.ca
Nataliya Milman
- Recruiting
Sherbrooke University Hospital Centre
Sherbrooke, Quebec, J1H 5N4
Patrick Liang, patrick.liang@usherbrooke.ca
Patrick Liang
- Recruiting
Mount Sinai Hospital, Toronto
Toronto, Ontario, ON M5T 2S8
Simon Carette, Simon.Carette@uhn.on.ca
Simon Carette
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3A 1M4
Navjot Dhindsa, ndhindsa@hsc.mb.ca
Navjot Dhindsa
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Hacettepe University
Ankara
Omer Karadag, omerkaradag@ymail.com
Omer Karadag
- Recruiting
Istanbul University, Cerrahpasa Medical School
Istanbul, 34098
Gulen Hatemi, gulen.hatemi@yahoo.com
Gulen Hatemi
- Recruiting
Marmara University Medical School
Istanbul, 34668
Haner Direskeneli, hanerdireskeneli@gmail.com
Haner Direskeneli
- Recruiting
Fatih University Medical Faculty
Istanbul, 34844
Seval Pehlivan, sevalpehlevan@gmail.com
Seval Pehlivan
- Not yet recruiting
Haydarpasa Education and Research Hospital
Istanbul
Hasan Yazici, hyazici@attglobal.net
Hasan Yazici
- Recruiting
Istanbul University, Istanbul Medical School
Istanbul
Sevil Kamali, sevilkamali@hotmail.com
Sevil Kamali
Germany5 sites, 5 recruiting
- Recruiting
Universitätsklinikum Jena
Jena, 07743 Jena
Thomas Neumann, Thomas.Neumann@med.uni-jena.de
Thomas Neumann
- Recruiting
University of Schleswig-Holstein
Lübeck
Julia Holle, hollejulia@hotmail.com
Julia Holle
- Recruiting
Universitätsklinikum Münster
Münster, Münster, 48149
Cord Sunderkötter, Cord.Sunderkoetter@ukmuenster.de
Cord Sunderkötter
- Recruiting
Kreiskliniken Esslingen
Plochingen, 73207
Bernhard Hellmich, b.hellmich@kk-es.de
Bernhard Hellmich
- Recruiting
University Hospital Tübingen
Tübingen, D-72076
Joerg Henes, joerg.henes@med.uni-tuebingen.de
Joerg Henes
India5 sites, 5 recruiting
- Recruiting
Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh, Pin- 160 012
Aman Sharma, pgimer-chd@nic.in
Aman Sharma
- Recruiting
Nizam's Institute of Medical Sciences, Hyderabad
Hyderabad, 500082
Liza Rajasekhar, lizarajasekhar@gmail.com
Liza Rajasekhar
- Recruiting
Chatrapathi Shahuji Maharaj Medical Center, Lucknow (IProcess)
Lucknow, Uttar Pradesh, 226003
Siddhart Das
Siddhart Das
- Recruiting
Medanta, Delhi
New Delhi, 110024
Rajiva Gupta, guptarajiva@hotmail.com
Rajiva Gupta
- Recruiting
Christian Medical College & Hospital, Vellore
Vellore, 632 004
Debashish Danda, debashish.danda@cmcvellore.ac.in
Debashish Danda
Sweden5 sites, 5 recruiting
- Recruiting
Lund University
Lund, Lund, SE-221 85
Aladdin Mohammad, aladdin.mohammad@med.lu.se
Mårten Segelmark
- Not yet recruiting
Karolinska Institute, Stockholm
Stockholm, 141 86
Johan Bratt, johan.bratt@karolinska.se
Johan Bratt
- Recruiting
Linköping University
Stockholm, 581 83
Marten Segelmark, marten.segelmark@liu.se
Marten Segelmark
- Not yet recruiting
Umeå University
Umeå, 901 85
Ewa Berglin, ewa.berglin@vll.se
Ewa Berglin
- Not yet recruiting
Uppsala University Hospital
Uppsala, 751 85
Ann Knight, ann.kataja.knight@akademiska.se
Ann Knight
New Zealand4 sites, 4 recruiting
- Recruiting
Auckland District Health Board
Auckland
Ravi Suppiah
Ravi Suppiah
- Not yet recruiting
Waitemata District Health Board, North Shore Hospital
Auckland
Janak de Zoysa, janak.dezoysa@waitematadhb.govt.nz
Janak de Zoysa
- Recruiting
University of Otago, Christchurch
Christchurch, Canterbury, 8011
Lisa Stamp, Lisa.Stamp@cdhb.govt.nz
Lisa Stamp
- Recruiting
Waikato District Health Board
Hamilton, 3240
Vicky Quincey, vicki.quincey@waikatodhb.health.nz
Vicky Quincey
Italy3 sites, 3 recruiting
- Recruiting
University of Parma
Parma
Augusto Vaglio, augusto.vaglio@virgilio.it
Augusto Vaglio
- Recruiting
Santa Maria Nuova Hospital, Reggio Emilia
Reggio Emilia, 42123
Carlo Salvarani, Carlo.Salvarani@asmn.re.it
Carlo Salvarani
- Recruiting
Arcispedale Santa Maria Nuova
Reggio Emilia
Carlo Salvarani, Carlo.Salvarani@asmn.re.it
Carlo Salvarani
Portugal3 sites, 3 recruiting
- Recruiting
Hospital Garcia de Orta, Almada
Almada
Miguel Rodrigues, mig.rodrigues69@gmail.com
Miguel Rodrigues
- Recruiting
Santa Maria Hospital, Lisbon
Lisbon, 1649-035
Ruth Geraldes, ruth.geraldes@netcabo.pt
Ruth Geraldes
- Recruiting
Hospital Santo Antonio, Porto
Porto, 4099 - 001
Ernestina Santos, ernestina.santos@gmail.com
Ernestina Santos
Argentina2 sites, 2 recruiting
- Recruiting
Ramos Mejia Hospital, University of Buenos Aires
Buenos Aires, C1221ADC
Eduardo Kerzberg, eduardomariok@gmail.com
Eduardo Kerzberg
- Recruiting
Hospital Interzonal San Juan Bautista
Catamarca, Catamarca Province
Sergio Toloza, sergiotol@yahoo.com
Sergio Toloza
Australia2 sites, 2 recruiting
- Recruiting
ANU Medical Centre
Canberra, Australian Capital Territory
Paul Gatenby, paul-gatenby@anu.edu.au
Paul Gatenby
- Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Dwarakanathan Ranganathan, Dwarakanathan_Ranganathan@health.qld.gov.au
Dwarakanathan Ranganathan
Czechia2 sites, 2 recruiting
- Recruiting
General University Hospital, Prague
Prague, 128 08
Vladimir Tesar, vladimir.tesar@lf1.cuni.cz
Vladimir Tesar
- Recruiting
General University Hospital
Prague
Vladamir Tesar
Vladamir Tesar
Egypt2 sites, 2 recruiting
- Recruiting
Assiut University, Assiut University Hospitals
Asyut, 71516
Nevin Hammam, nevin.hammam@gmail.com
Nevin Hammam
- Recruiting
Cairo University, Kasr El Ainy Hospital
Cairo
Amira Shahin, amirashahin@hotmail.com
Amira Shahin
Ireland2 sites, 2 recruiting
- Recruiting
Cork University Hospital
Cork
Michael Clarkson, michael.clarkson@hse.ie
Michael Clarkson
- Recruiting
St. Vincent's University Hospital, Dublin
Dublin
Eamonn Molloy, E.Molloy@st-vincents.ie
Eamonn Molloy
Mexico2 sites, 2 recruiting
- Recruiting
Instituto Nacional de Enfermedades Respiratorias
Mexico City, 14000
Luis Felipe Flores-Suárez, felipe98@prodigy.net.mx
Luis Felipe Flores-Suárez
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City
Andrea Hinojosa
Andrea Hinojosa
Netherlands2 sites, 2 recruiting
- Not yet recruiting
VU University Medical Center
Amsterdam, 6Z 165
Maarten Boers, mboers56@xs4all.nl
Maarten Boers
- Recruiting
University Medical Center Groningen
Groningen, 30.001
Abraham Rutgers, a.rutgers@umgc.nl
Abraham Rutgers
Norway2 sites, 2 recruiting
- Recruiting
Hospital of Southern Norway
Kristiansand, Post box 416, 4605
Andreas Diamantopoulos, +47 38073155, andreas.diamantopoulos@sshf.no
Andreas Diamantopoulos
- Recruiting
The University Hospital of Northern Norway, Tromsø
Tromsø, 9038
Emilio Besada, Emilio.Besada@unn.no
Emilio Besada
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Thomas Daikeler, tdaikeler@uhvs.ch
Thomas Daikeler
- Not yet recruiting
Immunologie-Zentrum Zurich
Zurich
Thomas Hauser, hauser@immunologie-zentrum.ch
Thomas Hauser
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck
Andreas Kronbichler, Andreas.Kronbichler@i-med.ac.at
Andreas Kronbichler
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven
Daniel Blockmans, Daniel.Blockmans@uz.kuleuven.ac.be
Daniel Blockmans
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Beijing
Beijing, 100032
Xinping Tian, tianxp6@126.com
Xinping Tian
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Neils Rasmussen, nrasent@dadlnet.dk
Niels Rasmussen
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki
Jukka Putaala, jukka.putaala@hus.fi
Jukka Putaala
France1 site, 1 recruiting
- Not yet recruiting
Cochin Hospital, Université Paris-descartes
Paris, 75679
Loic Guillevin, loic.guillevin@wanadoo.fr
Loic Guillevin
Hungary1 site, 1 recruiting
- Recruiting
University of Debrecen Medical and Health Science Center
Debrecen, 4032
Zoltan Szekanecz, szekanecz.zoltan@med.unideb.hu
Zoltan Szekanecz
Poland1 site, 1 recruiting
- Recruiting
University of Jagiellonian
Krakow, 31-007
Jan Sznajd, jsznajd@gmail.com
Jan Sznajd
Russia1 site, 1 recruiting
- Recruiting
First Moscow State Medical University
Moscow, 119991
Sergey Moiseev, clinpharm@mtu-net.ru
Sergey Moiseev
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Alojzija Hočevar, alojzija.hocevar@siol.net
Alojzija Hočevar
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Yeong-Wook Song, ysong@snu.ac.kr
Yeong-Wook Song
Spain1 site, 1 recruiting
- Recruiting
Clinic Barcelona Hospital Universitari
Barcelona, Catalonia
Maria Cid, MCCID@clinic.ub.es
Maria Cid
Sri Lanka1 site, 1 recruiting
- Recruiting
University of Colombo
Colombo
Inoshi Atukorala, inoshi.atu@gmail.com
Inoshi Atukorala
About this study
Official title: ACR/EULAR Endorsed Study to Develop New Diagnostic and Classification Criteria for Primary Systemic Vasculitis
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.
Read the 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
- Conditions
- Wegener's Granulomatosis, Microscopic Polyangiitis, Churg Strauss Syndrome, Polyarteritis Nodosa, Giant Cell Arteritis, Takayasu Arteritis
- Keywords
- Classification criteria, Diagnostic criteria
- Medical subject headings
- Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa, Giant Cell Arteritis, Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop new diagnostic and classification criteria for ANCA associated vasculitis and polyarteritis nodosa
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Wegener's GranulomatosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Rheumatology, The European League Against Rheumatism (EULAR), The Vasculitis foundation
- Responsible party
- Sponsor
- Investigators
- Raashid A Luqmani, DM, FRCP(E), Principal investigator, University of Oxford, United KingdomPeter Merkel, MD, MPH, Principal investigator, University of PennsylvaniaRichard Watts, DM, FRCP, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066208
- Sponsor's protocol ID
- ACREULAR001
- Acronym
- DCVAS
- Status last verified
- Aug 2016
- First submitted
- 9 Feb 2010
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16739201Rao 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.
PubMed 9735061Hunder 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.
PubMed 2390119Fries 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.
PubMed 2202312Jennette 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.
PubMed 8129773Sorensen 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.
PubMed 10834866Felson 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.
PubMed 7656339Yates 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.
PubMed 27940595
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACR/EULAR Endorsed Study to Develop New Diagnostic and Classification Criteria for Primary Systemic Vasculitis
- ClinicalTrials.gov ID
- NCT01066208
- Acronym / sponsor ID
- DCVAS / ACREULAR001
- Conditions
- Wegener's Granulomatosis, Microscopic Polyangiitis, Churg Strauss Syndrome, Polyarteritis Nodosa, Giant Cell Arteritis, Takayasu Arteritis
- Keywords
- Classification criteria, Diagnostic criteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,588 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- American College of Rheumatology, The European League Against Rheumatism (EULAR), The Vasculitis foundation
- Study start
- Jan 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Adult patients aged >18 years. There is no upper age limit.
- 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.
- Presumed diagnosis of a primary systemic vasculitis.
- Adult patients aged >18 years. There is no upper age limit.
- 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.
Key exclusion criteria (6 listed)
- Patients < 18 years of age.
- Inability to provide informed consent.
- Hepatitis B or C
- 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.
- Patients under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop new diagnostic and classification criteria for ANCA associated vasculitis and polyarteritis nodosa
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Background: PubMed 16739201Singh 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.
- Background: PubMed 9735061Rao 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.
- Background: PubMed 2390119Hunder 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.
- Background: PubMed 2202312Fries 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.
- Background: PubMed 8129773Jennette 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.
- Background: PubMed 10834866Sorensen 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.
- Background: PubMed 7656339Felson 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.
- Derived from this study: PubMed 27940595Yates 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.
- Website for European Vasculitis Study Group (EUVAS)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthea Craven contact
Raashid A Luqmani, DM, FRCP(E) principal investigator
University of Oxford, United Kingdom
Peter Merkel, MD, MPH principal investigator
University of Pennsylvania
Richard Watts, DM, FRCP principal investigator
University of East Anglia
120 sites in 33 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wegener's Granulomatosis and Microscopic Polyangiitis, run by University of Oxford at 120 sites in 33 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 120 sites in United Kingdom, United States, Japan, Canada, Turkey (Türkiye) and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raashid A Luqmani (+44 1865 738106, raashid.luqmani@ndorms.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop new diagnostic and classification criteria for ANCA associated vasculitis and polyarteritis nodosa (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01066208, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.