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

Study 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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT01066208

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
University of Oxford

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Raashid A Luqmani, DM, FRCP(E)Peter Merkel, MD, MPHRichard Watts, DM, FRCP
Principal Investigator Affiliation University of Oxford, United KingdomUniversity of PennsylvaniaUniversity of East Anglia

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOtherOtherOther
Overall Status Recruiting
Countries Argentina, Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Slovenia, Spain, Sri Lanka, Sweden, Switzerland, Turkey, United Kingdom, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Wegener's Granulomatosis, Microscopic Polyangiitis, Churg Strauss Syndrome, Polyarteritis Nodosa, Giant Cell Arteritis, Takayasu Arteritis
Study Website: View Trial Website
Additional Details

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35233

Site Contact

Angelo Gaffo

agaffo@uab.edu

+44 1865 738106

Cedars-Sinai Medical Center, LA, Los Angeles, California

Status

Recruiting

Address

Cedars-Sinai Medical Center, LA

Los Angeles, California, 90048

Site Contact

Michael Weisman

Weisman@cshs.org

+44 1865 738106

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94143-0500

Site Contact

Sharon Chung

sharon.chung@ucsf.edu

+44 1865 738106

University of Maryland, Baltimore, Maryland

Status

Recruiting

Address

University of Maryland

Baltimore, Maryland, 21201

Site Contact

Jamal Mikdashi

jmikdash@umaryland.edu

+44 1865 738106

Boston, Massachusetts

Status

Recruiting

Address

Vasculitis Center, Boston University School of Medicine

Boston, Massachusetts, 02118

Site Contact

Peter Grayson

peter.grayson@bmc.org

+44 1865 738106

Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan, Internal Medicine

Ann Arbor, Michigan, 48109

Site Contact

William J McCune

jmccune@med.umich.edu

+44 1865 738106

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Eric Matteson

matteson.eric@mayo.edu

+44 1865 738106

Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Hitchcock Medical Centre, Lebanon, NH

Lebanon, New Hampshire, 03756

Site Contact

Daniel A Albert

Daniel.A.Albert@Hitchcock.ORG

+44 1865 738106

New York, New York

Status

Not yet recruiting

Address

New York University Langone Medical Centre

New York, New York, 10016

Site Contact

Yusuf Yazici

yusuf.yazici@nyumc.org

+44 1865 738106

University of North Carolina, Chapel Hill, North Carolina

Status

Not yet recruiting

Address

University of North Carolina

Chapel Hill, North Carolina, 27599-7525

Site Contact

Charles Jennette

jcj@med.unc.edu

+44 1865 738106

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Carol Langford

LANGFOC@ccf.org

+44 1865 738106

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Peter A Merkel

pmerkel@upenn.edu

+44 1865 738106

University of Pittsburgh, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261

Site Contact

Kim Liang

liangkp@upmc.edu

+44 1865 738106

University Medical Center, Salt Lake City, Utah

Status

Not yet recruiting

Address

University Medical Center

Salt Lake City, Utah, 84132-0002

Site Contact

Curry Koening

curry.koening@hsc.utah.edu

+44 1865 738106

International Sites

Hospital Interzonal San Juan Bautista, San Fernando del Valle de Catamarca, Catamarca, Argentina

Status

Recruiting

Address

Hospital Interzonal San Juan Bautista

San Fernando del Valle de Catamarca, Catamarca,

Site Contact

Sergio Toloza

sergiotol@yahoo.com

+44 1865 738106

Buenos Aires, Argentina

Status

Recruiting

Address

Ramos Mejia Hospital, University of Buenos Aires

Buenos Aires, , C1221ADC

Site Contact

Eduardo Kerzberg

eduardomariok@gmail.com

+44 1865 738106

ANU Medical Centre, Canberra, Australian Capital Territory, Australia

Status

Recruiting

Address

ANU Medical Centre

Canberra, Australian Capital Territory,

Site Contact

Paul Gatenby

paul-gatenby@anu.edu.au

+44 1865 738106

Royal Brisbane and Women's Hospital, Herston, Queensland, Australia

Status

Recruiting

Address

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029

Site Contact

Dwarakanathan Ranganathan

Dwarakanathan_Ranganathan@health.qld.gov.au

+44 1865 738106

Medical University Innsbruck, Innsbruck, Austria

Status

Recruiting

Address

Medical University Innsbruck

Innsbruck, ,

Site Contact

Andreas Kronbichler

Andreas.Kronbichler@i-med.ac.at

+44 1865 738106

University Hospitals Leuven, Leuven, Belgium

Status

Recruiting

Address

University Hospitals Leuven

Leuven, ,

Site Contact

Daniel Blockmans

Daniel.Blockmans@uz.kuleuven.ac.be

+44 1865 738106

University of Manitoba, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

University of Manitoba

Winnipeg, Manitoba, R3A 1M4

Site Contact

Navjot Dhindsa

ndhindsa@hsc.mb.ca

+44 1865 738106

St Joseph's Healthcare, Hamilton, Ontario, Canada

Status

Recruiting

Address

St Joseph's Healthcare

Hamilton, Ontario,

Site Contact

Nader Khalidi

naderkhalidi@sympatico.ca

+44 1865 738106

University of Ottawa, Ottawa, Ontario, Canada

Status

Recruiting

Address

University of Ottawa

Ottawa, Ontario, K1N 6N5

Site Contact

Nataliya Milman

nmilman@Ottawahospital.on.ca

+44 1865 738106

Mount Sinai Hospital, Toronto, Toronto, Ontario, Canada

Status

Recruiting

Address

Mount Sinai Hospital, Toronto

Toronto, Ontario, ON M5T 2S8

Site Contact

Simon Carette

Simon.Carette@uhn.on.ca

+44 1865 738106

McGill University, Montreal, Quebec, Canada

Status

Recruiting

Address

McGill University

Montreal, Quebec, H3A 0G4

Site Contact

Christian Pineau

christian.pineau@mcgill.ca

+44 1865 738106

Sherbrooke University Hospital Centre, Sherbrooke, Quebec, Canada

Status

Recruiting

Address

Sherbrooke University Hospital Centre

Sherbrooke, Quebec, J1H 5N4

Site Contact

Patrick Liang

patrick.liang@usherbrooke.ca

+44 1865 738106

University of Calgary, Calgary, Canada

Status

Not yet recruiting

Address

University of Calgary

Calgary, ,

Site Contact

Michael Walsh

mwwalsh@ucalgary.ca

+44 1865 738106

St Joseph's Healthcare London, Ontario, Ontario, Canada

Status

Recruiting

Address

St Joseph's Healthcare London, Ontario

Ontario, ,

Site Contact

Lillian Barra

+44 1865 738106

Beijing, China

Status

Recruiting

Address

Peking Union Medical College Hospital, Beijing

Beijing, , 100032

Site Contact

Xinping Tian

tianxp6@126.com

+44 1865 738106

General University Hospital, Prague, Prague, Czech Republic

Status

Recruiting

Address

General University Hospital, Prague

Prague, , 128 08

Site Contact

Vladimir Tesar

vladimir.tesar@lf1.cuni.cz

+44 1865 738106

General University Hospital, Prague, Czech Republic

Status

Recruiting

Address

General University Hospital

Prague, ,

Site Contact

Vladamir Tesar

+44 1865 738106

Rigshospitalet, Copenhagen, Denmark

Status

Recruiting

Address

Rigshospitalet

Copenhagen, ,

Site Contact

Neils Rasmussen

nrasent@dadlnet.dk

+44 1865 738106

Assiut, Egypt

Status

Recruiting

Address

Assiut University, Assiut University Hospitals

Assiut, , 71516

Site Contact

Nevin Hammam

nevin.hammam@gmail.com

+44 1865 738106

Cairo University, Kasr El Ainy Hospital, Cairo, Egypt

Status

Recruiting

Address

Cairo University, Kasr El Ainy Hospital

Cairo, ,

Site Contact

Amira Shahin

amirashahin@hotmail.com

+44 1865 738106

Helsinki University Central Hospital, Helsinki, Finland

Status

Recruiting

Address

Helsinki University Central Hospital

Helsinki, ,

Site Contact

Jukka Putaala

jukka.putaala@hus.fi

+44 1865 738106

Paris, France

Status

Not yet recruiting

Address

Cochin Hospital, Université Paris-descartes

Paris, , 75679

Site Contact

Loic Guillevin

loic.guillevin@wanadoo.fr

+44 1865 738106

Universitätsklinikum Jena, Jena, Germany

Status

Recruiting

Address

Universitätsklinikum Jena

Jena, , 07743 Jena

Site Contact

Thomas Neumann

Thomas.Neumann@med.uni-jena.de

+44 1865 738106

University of Schleswig-Holstein, Luebeck, Germany

Status

Recruiting

Address

University of Schleswig-Holstein

Luebeck, ,

Site Contact

Julia Holle

hollejulia@hotmail.com

+44 1865 738106

Universitätsklinikum Münster, Münster, Germany

Status

Recruiting

Address

Universitätsklinikum Münster

Münster, , 48149

Site Contact

Cord Sunderkötter

Cord.Sunderkoetter@ukmuenster.de

+44 1865 738106

Kreiskliniken Esslingen, Plochingen, Germany

Status

Recruiting

Address

Kreiskliniken Esslingen

Plochingen, , 73207

Site Contact

Bernhard Hellmich

b.hellmich@kk-es.de

+44 1865 738106

University Hospital Tübingen, Tübingen, Germany

Status

Recruiting

Address

University Hospital Tübingen

Tübingen, , D-72076

Debrecen, Hungary

Status

Recruiting

Address

University of Debrecen Medical and Health Science Center

Debrecen, , 4032

Site Contact

Zoltan Szekanecz

szekanecz.zoltan@med.unideb.hu

+44 1865 738106

Lucknow, Uttar Pradesh, India

Status

Recruiting

Address

Chatrapathi Shahuji Maharaj Medical Center, Lucknow (IProcess)

Lucknow, Uttar Pradesh, 226003

Site Contact

Siddhart Das

+44 1865 738106

Chandigarh, India

Status

Recruiting

Address

Postgraduate Institute of Medical Education and Research, Chandigarh

Chandigarh, , Pin- 160 012

Site Contact

Aman Sharma

pgimer-chd@nic.in

+44 1865 738106

Hyderabad, India

Status

Recruiting

Address

Nizam's Institute of Medical Sciences, Hyderabad

Hyderabad, , 500082

Site Contact

Liza Rajasekhar

lizarajasekhar@gmail.com

+44 1865 738106

Medanta, Delhi, New Delhi, India

Status

Recruiting

Address

Medanta, Delhi

New Delhi, , 110024

Site Contact

Rajiva Gupta

guptarajiva@hotmail.com

+44 1865 738106

Vellore, India

Status

Recruiting

Address

Christian Medical College & Hospital, Vellore

Vellore, , 632 004

Site Contact

Debashish Danda

debashish.danda@cmcvellore.ac.in

+44 1865 738106

Cork University Hospital, Cork, Ireland

Status

Recruiting

Address

Cork University Hospital

Cork, ,

Site Contact

Michael Clarkson

michael.clarkson@hse.ie

+44 1865 738106

Dublin 4, Ireland

Status

Recruiting

Address

St. Vincent's University Hospital, Dublin

Dublin 4, ,

Site Contact

Eamonn Molloy

E.Molloy@st-vincents.ie

+44 1865 738106

University of Parma, Parma, Italy

Status

Recruiting

Address

University of Parma

Parma, ,

Site Contact

Augusto Vaglio

augusto.vaglio@virgilio.it

+44 1865 738106

Reggio Emilia, Italy

Status

Recruiting

Address

Santa Maria Nuova Hospital, Reggio Emilia

Reggio Emilia, , 42123

Site Contact

Carlo Salvarani

Carlo.Salvarani@asmn.re.it

+44 1865 738106

Arcispedale Santa Maria Nuova, Reggio Emilia, Italy

Status

Recruiting

Address

Arcispedale Santa Maria Nuova

Reggio Emilia, ,

Site Contact

Carlo Salvarani

Carlo.Salvarani@asmn.re.it

+44 1865 738106

Kameda Medical Centre, Kamogawa, Kamogawa City, Chiba prefecture, Japan

Status

Recruiting

Address

Kameda Medical Centre, Kamogawa

Kamogawa City, Chiba prefecture, 296-8602

Site Contact

Kazuo Matsui

pxu17054@nifty.com

+44 1865 738106

Tsukuba University Hospital, Tsukuba, Ibaraki Prefecture, Japan

Status

Recruiting

Address

Tsukuba University Hospital

Tsukuba, Ibaraki Prefecture, 305-8576

Site Contact

Kunihiro Yamagata

+44 1865 738106

Miyazaki University Hospital, Miyazaki City, Miyazaki Prefecture, Japan

Status

Recruiting

Address

Miyazaki University Hospital

Miyazaki City, Miyazaki Prefecture, 889-1692

Site Contact

Shouichi Fujimoto

+44 1865 738106

Saitama Medical University, Kawagoe, Saitama Prefecture, Japan

Status

Recruiting

Address

Saitama Medical University

Kawagoe, Saitama Prefecture, 350-8550

Site Contact

Koichi Amano

amanokoi@saitama-med.ac.jp

+44 1865 738106

Kyorin University Hospital, Mitaka, Tokyo Prefecture, Japan

Status

Recruiting

Address

Kyorin University Hospital

Mitaka, Tokyo Prefecture, 181-8611

Site Contact

Yoshihiro Arimura

+44 1865 738106

Chiba University, Chiba, Japan

Status

Recruiting

Address

Chiba University

Chiba, , 260-8670

Site Contact

Kazuo Suzuki

ksuzuki@faculty.chiba-u.jp

+44 1865 738106

Kagawa University Hospital, Kagawa, Japan

Status

Recruiting

Address

Kagawa University Hospital

Kagawa, , 761-0793

Site Contact

Hiroaki Dobashi

+44 1865 738106

St. Marianna University Hospital, Kanagawa, Japan

Status

Recruiting

Address

St. Marianna University Hospital

Kanagawa, , 216-8511

Site Contact

Hidehiro Yamada

guriko@marianna-u.ac.jp

+44 1865 738106

Kanazawa University Hospital, Kanazawa, Japan

Status

Recruiting

Address

Kanazawa University Hospital

Kanazawa, , 920-8641

Okayama University Hospital, Okayama, Japan

Status

Recruiting

Address

Okayama University Hospital

Okayama, , 700-8558

Site Contact

Hirofumi Makino

+44 1865 738106

Kitano Hospital, Osaka, Japan

Status

Recruiting

Address

Kitano Hospital

Osaka, ,

Site Contact

Eri Muso

+44 1865 738106

Juntendo University Koshigaya Hospital, Saitama, Japan

Status

Recruiting

Address

Juntendo University Koshigaya Hospital

Saitama, , 343-0032

Site Contact

Shigeto Kobayashi

+44 1865 738106

Jichi Medical University Hospital, Tochigi-ken, Japan

Status

Recruiting

Address

Jichi Medical University Hospital

Tochigi-ken, , 3311-1 Yakushiji

Site Contact

Wako Yumura

+44 1865 738106

University Tokyo Hospital, Tokyo, Japan

Status

Recruiting

Address

University Tokyo Hospital

Tokyo, , 113-8655

Site Contact

Junichi Hirahashi

jhirahashi-tky@umin.ac.jp

+44 1865 738106

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 110-744

Site Contact

Yeong-Wook Song

ysong@snu.ac.kr

+44 1865 738106

Mexico City, Mexico

Status

Recruiting

Address

Instituto Nacional de Enfermedades Respiratorias

Mexico City, , 14000

Site Contact

Luis Felipe Flores-Suárez

felipe98@prodigy.net.mx

+44 1865 738106

Mexico City, Mexico

Status

Recruiting

Address

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, ,

Site Contact

Andrea Hinojosa

+44 1865 738106

VU University Medical Center, Amsterdam, Netherlands

Status

Not yet recruiting

Address

VU University Medical Center

Amsterdam, , 6Z 165

Site Contact

Maarten Boers

mboers56@xs4all.nl

+44 1865 738106

University Medical Center Groningen, Groningen, Netherlands

Status

Recruiting

Address

University Medical Center Groningen

Groningen, , 30.001

Site Contact

Abraham Rutgers

a.rutgers@umgc.nl

+44 1865 738106

University of Otago, Christchurch, Christchurch, Canterbury, New Zealand

Status

Recruiting

Address

University of Otago, Christchurch

Christchurch, Canterbury, 8011

Site Contact

Lisa Stamp

Lisa.Stamp@cdhb.govt.nz

+44 1865 738106

Auckland District Health Board, Auckland, New Zealand

Status

Recruiting

Address

Auckland District Health Board

Auckland, ,

Site Contact

Ravi Suppiah

+44 1865 738106

Auckland, New Zealand

Status

Not yet recruiting

Address

Waitemata District Health Board, North Shore Hospital

Auckland, ,

Waikato District Health Board, Hamilton, New Zealand

Status

Recruiting

Address

Waikato District Health Board

Hamilton, , 3240

Hospital of Southern Norway, Kristiansand, Norway

Status

Recruiting

Address

Hospital of Southern Norway

Kristiansand, , Post box 416, 4605

Site Contact

Andreas Diamantopoulos

andreas.diamantopoulos@sshf.no

+47 38073155

Tromsø, Norway

Status

Recruiting

Address

The University Hospital of Northern Norway, Tromsø

Tromsø, , 9038

Site Contact

Emilio Besada

Emilio.Besada@unn.no

+44 1865 738106

University of Jagiellonian, Kraków, Poland

Status

Recruiting

Address

University of Jagiellonian

Kraków, , 31-007

Site Contact

Jan Sznajd

jsznajd@gmail.com

+44 1865 738106

Hospital Garcia de Orta, Almada, Almada, Portugal

Status

Recruiting

Address

Hospital Garcia de Orta, Almada

Almada, ,

Site Contact

Miguel Rodrigues

mig.rodrigues69@gmail.com

+44 1865 738106

Santa Maria Hospital, Lisbon, Lisbon, Portugal

Status

Recruiting

Address

Santa Maria Hospital, Lisbon

Lisbon, , 1649-035

Site Contact

Ruth Geraldes

ruth.geraldes@netcabo.pt

+44 1865 738106

Hospital Santo Antonio, Porto, Porto, Portugal

Status

Recruiting

Address

Hospital Santo Antonio, Porto

Porto, , 4099 - 001

Site Contact

Ernestina Santos

ernestina.santos@gmail.com

+44 1865 738106

First Moscow State Medical University, Moscow, Russian Federation

Status

Recruiting

Address

First Moscow State Medical University

Moscow, , 119991

Site Contact

Sergey Moiseev

clinpharm@mtu-net.ru

+44 1865 738106

University Medical Centre Ljubljana, Ljubljana, Slovenia

Status

Recruiting

Address

University Medical Centre Ljubljana

Ljubljana, , 1000

Site Contact

Alojzija Hočevar

alojzija.hocevar@siol.net

+44 1865 738106

Clinic Barcelona Hospital Universitari, Barcelona, Catalonia, Spain

Status

Recruiting

Address

Clinic Barcelona Hospital Universitari

Barcelona, Catalonia,

Site Contact

Maria Cid

MCCID@clinic.ub.es

+44 1865 738106

University of Colombo, Columbo 8, Sri Lanka

Status

Recruiting

Address

University of Colombo

Columbo 8, ,

Site Contact

Inoshi Atukorala

inoshi.atu@gmail.com

+44 1865 738106

Lund University, Lund, Sweden

Status

Recruiting

Address

Lund University

Lund, , SE-221 85

Site Contact

Aladdin Mohammad

aladdin.mohammad@med.lu.se

+44 1865 738106

Karolinska Institute, Stockholm, Stockholm, Sweden

Status

Not yet recruiting

Address

Karolinska Institute, Stockholm

Stockholm, , 141 86

Site Contact

Johan Bratt

johan.bratt@karolinska.se

+44 1865 738106

Linköping University, Stockholm, Sweden

Status

Recruiting

Address

Linköping University

Stockholm, , 581 83

Site Contact

Marten Segelmark

marten.segelmark@liu.se

+44 1865 738106

Umeå University, Umeå, Sweden

Status

Not yet recruiting

Address

Umeå University

Umeå, , 901 85

Site Contact

Ewa Berglin

ewa.berglin@vll.se

+44 1865 738106

Uppsala University Hospital, Uppsala, Sweden

Status

Not yet recruiting

Address

Uppsala University Hospital

Uppsala, , 751 85

University Hospital Basel, Basel, Switzerland

Status

Recruiting

Address

University Hospital Basel

Basel, , 4031

Site Contact

Thomas Daikeler

tdaikeler@uhvs.ch

+44 1865 738106

Immunologie-Zentrum Zurich, Zurich, Switzerland

Status

Not yet recruiting

Address

Immunologie-Zentrum Zurich

Zurich, ,

Site Contact

Thomas Hauser

hauser@immunologie-zentrum.ch

+44 1865 738106

Hacettepe University, Ankara, Turkey

Status

Recruiting

Address

Hacettepe University

Ankara, ,

Site Contact

Omer Karadag

omerkaradag@ymail.com

+44 1865 738106

Istanbul, Turkey

Status

Recruiting

Address

Istanbul University, Cerrahpasa Medical School

Istanbul, , 34098

Site Contact

Gulen Hatemi

gulen.hatemi@yahoo.com

+44 1865 738106

Marmara University Medical School, Istanbul, Turkey

Status

Recruiting

Address

Marmara University Medical School

Istanbul, , 34668

Site Contact

Haner Direskeneli

hanerdireskeneli@gmail.com

+44 1865 738106

Fatih University Medical Faculty, Istanbul, Turkey

Status

Recruiting

Address

Fatih University Medical Faculty

Istanbul, , 34844

Site Contact

Seval Pehlivan

sevalpehlevan@gmail.com

+44 1865 738106

Istanbul, Turkey

Status

Not yet recruiting

Address

Haydarpasa Education and Research Hospital

Istanbul, ,

Site Contact

Hasan Yazici

hyazici@attglobal.net

+44 1865 738106

Istanbul, Turkey

Status

Recruiting

Address

Istanbul University, Istanbul Medical School

Istanbul, ,

Site Contact

Sevil Kamali

sevilkamali@hotmail.com

+44 1865 738106

Carlisle, Cumbria, United Kingdom

Status

Recruiting

Address

North Cumbria University Hospitals, The Cumberland Infirmary

Carlisle, Cumbria, CA2 7HY

Site Contact

Alaa Hassan

Alaa.Hassan@ncuh.nhs.uk

+44 1865 738106

Basildon, Essex, United Kingdom

Status

Recruiting

Address

Basildon and Thurrock University Hospitals NHS Foundation Trust

Basildon, Essex, SS16 5NL

Site Contact

Nagui Gendi

+44 1865 738106

Queen's Hospital, Romford, Essex, United Kingdom

Status

Recruiting

Address

Queen's Hospital

Romford, Essex, RM7 0AG

Site Contact

Kuntal Chakravarty

kuntal@talk21.com

+44 1865 738106

Southend University Hospital NHS Trust, Westcliff-on-Sea, Essex, United Kingdom

Status

Recruiting

Address

Southend University Hospital NHS Trust

Westcliff-on-Sea, Essex, SS0 0RY

Site Contact

Bhaskar Dasgupta

Bhaskar.Dasgupta@southend.nhs.uk

+44 1865 738106

Kirkcaldy, Fife, United Kingdom

Status

Recruiting

Address

NHS Fife, Whyteman's Brae Hospital, Windygates

Kirkcaldy, Fife, KY8 5PR

Site Contact

John Mclaren

john.mclaren2@nhs.net

+44 1865 738106

Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom

Status

Recruiting

Address

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN

Site Contact

Neil Basu

neilbasu@nhs.net

+44 1865 738106

Glasgow, Scotland, United Kingdom

Status

Recruiting

Address

NHS Greater Glasgow & Clyde, Gartnavel Hospital

Glasgow, Scotland, G12 8TA

Site Contact

Iain McInnes

iain.mcinnes@glasgow.ac.uk

+44 1865 738106

Ipswich Hospital NHS Trust, Ipswich, Suffolk, United Kingdom

Status

Recruiting

Address

Ipswich Hospital NHS Trust

Ipswich, Suffolk,

Site Contact

Richard Watts

richard.watts2@mac.com

+44 1865 738106

Carshalton, Surrey, United Kingdom

Status

Recruiting

Address

Epsom and St Helier University Hospitals NHS Trust

Carshalton, Surrey, SM5 1AA

Site Contact

Sanjeev Patel

+44 1865 738106

University of Birmingham, Birmingham, United Kingdom

Status

Recruiting

Address

University of Birmingham

Birmingham, ,

Site Contact

Matthew Morgan

m.d.morgan@bham.ac.uk

+44 1865 738106

Addenbrooke's Hospital, Cambridge, United Kingdom

Status

Recruiting

Address

Addenbrooke's Hospital

Cambridge, ,

Dudley Group of Hospitals, NHS FT, Dudley, United Kingdom

Status

Recruiting

Address

Dudley Group of Hospitals, NHS FT

Dudley, , DY1 2HQ

Site Contact

Rainer Kloche

0044 1384 244807

London, United Kingdom

Status

Recruiting

Address

Imperial College Healthcare NHS Trust, Hammersmith Hospital

London, , W12 0HS

Site Contact

Justin Mason

justin.mason@imperial.ac.uk

+44 1865 738106

Manchester, United Kingdom

Status

Recruiting

Address

University of Manchester, Manchester Royal Infirmary

Manchester, , M13 9WL

Norfolk and Norwich University Hospital, Norwich, United Kingdom

Status

Recruiting

Address

Norfolk and Norwich University Hospital

Norwich, , NR4 7UY

Site Contact

Laura Harper

LAURA.HARPER@nnuh.nhs.uk

+44 1865 738106

Nottingham, United Kingdom

Status

Recruiting

Address

Nottingham University Hospitals NHS Trust (QMC)

Nottingham, , NG7 2UH

Site Contact

Peter Lanyon

Peter.Lanyon@nuh.nhs.uk

+44 1865 738106

Nuffield Orthopaedic Centre, Oxford, United Kingdom

Status

Recruiting

Address

Nuffield Orthopaedic Centre

Oxford, , OX3 7LD

Site Contact

Raashid Luqmani

raashid.luqmani@noc.nhs.uk

+44 1865 738106

Oxford, United Kingdom

Status

Recruiting

Address

Oxford University Hospitals NHS Trust (The Churchill Hospital)

Oxford, , OX3 7LE

Site Contact

Rachel Hoyles

rachel.hoyles@ouht.nhs.uk

+44 1865 738106

Royal Berkshire NHS Trust, Reading, United Kingdom

Status

Recruiting

Address

Royal Berkshire NHS Trust

Reading, , RG1 5AN

Site Contact

Oliver Flossmann

oliver.flossman@royalberkshire.nhs.uk

0118 3225308

Slough, United Kingdom

Status

Recruiting

Address

Heatherwood & Wexham Park Hospitals NHS Foundation Trust

Slough, , SL2 4HL

Site Contact

Matthew Adler

Matthew.Adler@hwph-tr.nhs.uk

+44 1865 738106

Southampton, United Kingdom

Status

Withdrawn

Address

Southampton University Hospitals NHS Trust

Southampton, , SO16 6YD

Site Contact

+44 1865 738106

York Hospital NHS Foundation Trust, York, United Kingdom

Status

Recruiting

Address

York Hospital NHS Foundation Trust

York, , YO31 8HE

Site Contact

Colin Jones

Colin.H.Jones@York.NHS.UK

+44 1865 738106

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