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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Oxford
Sponsor:
Collaborators:
American College of Rheumatology
The European League Against Rheumatism (EULAR)
The Vasculitis foundation
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01066208
First received: February 9, 2010
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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
Wegener's Granulomatosis
Microscopic Polyangiitis
Churg Strauss Syndrome
Polyarteritis Nodosa
Giant Cell Arteritis
Takayasu Arteritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: ACR/EULAR Endorsed Study to Develop New Diagnostic and Classification Criteria for Primary Systemic Vasculitis

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Develop new diagnostic and classification criteria for ANCA associated vasculitis and polyarteritis nodosa [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 3588
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066208

Contacts
Contact: Raashid A Luqmani +44 1865 738106 raashid.luqmani@ndorms.ox.ac.uk
Contact: Anthea Craven anthea.craven@ndorms.ox.ac.uk

  Hide Study Locations
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 Recruiting
Prague, Czech Republic
Contact: Vladamir Tesar         
Principal Investigator: Vladamir Tesar         
General University Hospital, Prague Recruiting
Prague, Czech Republic, 128 08
Contact: Vladimir Tesar       vladimir.tesar@lf1.cuni.cz   
Principal Investigator: Vladimir 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 Ciencias Medicas y Nutricion Salvador Zubiran Recruiting
Mexico City, Mexico
Contact: Andrea Hinojosa         
Principal Investigator: Andrea Hinojosa         
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         
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         
Marmara University Medical School Recruiting
Istanbul, Turkey, 34668
Contact: Haner Direskeneli       hanerdireskeneli@gmail.com   
Principal Investigator: Haner Direskeneli         
Haydarpasa Education and Research Hospital Not yet recruiting
Istanbul, Turkey
Contact: Hasan Yazici       hyazici@attglobal.net   
Principal Investigator: Hasan Yazici         
Istanbul University, Cerrahpasa Medical School Recruiting
Istanbul, Turkey, 34098
Contact: Gulen Hatemi       gulen.hatemi@yahoo.com   
Principal Investigator: Gulen Hatemi         
Istanbul University, Istanbul Medical School Recruiting
Istanbul, Turkey
Contact: Sevil Kamali       sevilkamali@hotmail.com   
Principal Investigator: Sevil Kamali         
Fatih University Medical Faculty Recruiting
Istanbul, Turkey, 34844
Contact: Seval Pehlivan       sevalpehlevan@gmail.com   
Principal Investigator: Seval Pehlivan         
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         
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         
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         
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:
Publications:

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01066208     History of Changes
Other Study ID Numbers: ACREULAR001
Study First Received: February 9, 2010
Last Updated: June 3, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
Classification criteria
Diagnostic criteria

Additional relevant MeSH terms:
Aortic Arch Syndromes
Arteritis
Churg-Strauss Syndrome
Giant Cell Arteritis
Microscopic Polyangiitis
Polyarteritis Nodosa
Polymyalgia Rheumatica
Systemic Vasculitis
Takayasu Arteritis
Vasculitis
Wegener Granulomatosis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Aortic Diseases
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Connective Tissue Diseases
Granuloma
Immune System Diseases
Lung Diseases
Lung Diseases, Interstitial
Lymphatic Diseases
Lymphoproliferative Disorders
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014