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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01066208




Registration number
NCT01066208
Ethics application status
Date submitted
9/02/2010
Date registered
10/02/2010
Date last updated
19/08/2016

Titles & IDs
Public title
American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis
Scientific title
ACR/EULAR Endorsed Study to Develop New Diagnostic and Classification Criteria for Primary Systemic Vasculitis
Secondary ID [1] 0 0
ACREULAR001
Universal Trial Number (UTN)
Trial acronym
DCVAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wegener's Granulomatosis 0 0
Microscopic Polyangiitis 0 0
Churg Strauss Syndrome 0 0
Polyarteritis Nodosa 0 0
Giant Cell Arteritis 0 0
Takayasu Arteritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Develop new diagnostic and classification criteria for ANCA associated vasculitis and polyarteritis nodosa
Timepoint [1] 0 0
3 years

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2018
Actual
Sample size
Target
3588
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD
Recruitment hospital [1] 0 0
ANU Medical Centre - Canberra
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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New Hampshire
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Utah
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Argentina
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Catamarca
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Argentina
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Buenos Aires
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Austria
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Innsbruck
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Belgium
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Leuven
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Canada
State/province [17] 0 0
Manitoba
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Canada
State/province [20] 0 0
Calgary
Country [21] 0 0
China
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Beijing
Country [22] 0 0
Czech Republic
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Prague
Country [23] 0 0
Denmark
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Copenhagen
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Egypt
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Assiut
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Egypt
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Cairo
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Finland
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Helsinki
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France
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Paris
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Germany
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Jena
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Germany
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Luebeck
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Germany
State/province [30] 0 0
Münster
Country [31] 0 0
Germany
State/province [31] 0 0
Plochingen
Country [32] 0 0
Germany
State/province [32] 0 0
Tübingen
Country [33] 0 0
Hungary
State/province [33] 0 0
Debrecen
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India
State/province [34] 0 0
Uttar Pradesh
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India
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Chandigarh
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India
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Hyderabad
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India
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New Delhi
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India
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Vellore
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Ireland
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Cork
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Ireland
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Dublin 4
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Italy
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Parma
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Italy
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Reggio Emilia
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Japan
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Chiba prefecture
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Japan
State/province [44] 0 0
Ibaraki Prefecture
Country [45] 0 0
Japan
State/province [45] 0 0
Miyazaki Prefecture
Country [46] 0 0
Japan
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Saitama Prefecture
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Japan
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Tokyo Prefecture
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Japan
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Chiba
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Japan
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Kagawa
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Japan
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Kanagawa
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Japan
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Kanazawa
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tochigi-ken
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Japan
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Tokyo
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Korea, Republic of
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Seoul
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Mexico
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Mexico City
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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New Zealand
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Canterbury
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New Zealand
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Auckland
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New Zealand
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Hamilton
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Norway
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Kristiansand
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Norway
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Tromsø
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Poland
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Kraków
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Portugal
State/province [67] 0 0
Almada
Country [68] 0 0
Portugal
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Lisbon
Country [69] 0 0
Portugal
State/province [69] 0 0
Porto
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Russian Federation
State/province [70] 0 0
Moscow
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Slovenia
State/province [71] 0 0
Ljubljana
Country [72] 0 0
Spain
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Catalonia
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Sri Lanka
State/province [73] 0 0
Columbo 8
Country [74] 0 0
Sweden
State/province [74] 0 0
Lund
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Sweden
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Stockholm
Country [76] 0 0
Sweden
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Umeå
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Sweden
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Uppsala
Country [78] 0 0
Switzerland
State/province [78] 0 0
Basel
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Switzerland
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Zurich
Country [80] 0 0
Turkey
State/province [80] 0 0
Ankara
Country [81] 0 0
Turkey
State/province [81] 0 0
Istanbul
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Cumbria
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Essex
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Fife
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Scotland
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Suffolk
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Surrey
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Birmingham
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Cambridge
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Dudley
Country [91] 0 0
United Kingdom
State/province [91] 0 0
London
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Manchester
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Norwich
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Nottingham
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Oxford
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Reading
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Slough
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Southampton
Country [99] 0 0
United Kingdom
State/province [99] 0 0
York

Funding & Sponsors
Primary sponsor type
Other
Name
University of Oxford
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
American College of Rheumatology
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The European League Against Rheumatism (EULAR)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The Vasculitis foundation
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Vasculitis is group of diseases where inflammation of blood vessels is the common feature. Patients typically present with fever, fatigue, weakness and muscle and joint aches. These symptoms are very common among many different diseases, not just vasculitis. A clustering of other symptoms, physical examination findings, blood tests, radiology and biopsy help make the diagnosis. There are currently no criteria to help doctors make a diagnosis of vasculitis when a patient presents with these non specific symptoms and they are reliant on previous experience and disease definitions. One of the aims of this project is to develop diagnostic criteria for the primary systemic vasculitides (granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis, Churg Strauss syndrome, polyarteritis nodosa, giant cell arteritis, Takayasu arteritis). We, the investigators, will do this by studying a large group of patients with vasculitis and comparing them to a large group of patients that present in a similar way, but do not have vasculitis. By comparing the 2 groups we will create a list of items to differentiate between vasculitis and 'vasculitis mimics'.

We also aim to update the current classification criteria. Classification criteria are used to group patients into different types of vasculitis, once a diagnosis of vasculitis has been made, and are useful for studying patients in clinical trials with similar or identical diseases. The current classification criteria (American college of Rheumatology 1990 criteria) were developed 20 years ago, before the availability of some important diagnostic tests (e.g. antineutrophil cytoplasmic antibodies \[ANCA\]), and are now not consistent with some of the current disease definitions. Therefore to progress future research in vasculitis, it is important that the classification criteria are updated. We will recruit 260 patients with each of the 6 types of vasculitis and compare them with 1300 controls (patients with the 5 other types of vasculitis), in order to determine the optimal combination of symptoms, signs and investigations that classify each person into the appropriate group.
Trial website
https://clinicaltrials.gov/study/NCT01066208
Trial related presentations / publications
Singh JA, Solomon DH, Dougados M, Felson D, Hawker G, Katz P, Paulus H, Wallace C; Classification and Response Criteria Subcommittee of the Committee on Quality Measures, American College of Rheumatology. Development of classification and response criteria for rheumatic diseases. Arthritis Rheum. 2006 Jun 15;55(3):348-52. doi: 10.1002/art.22003.
Rao JK, Allen NB, Pincus T. Limitations of the 1990 American College of Rheumatology classification criteria in the diagnosis of vasculitis. Ann Intern Med. 1998 Sep 1;129(5):345-52. doi: 10.7326/0003-4819-129-5-199809010-00001.
Hunder GG, Arend WP, Bloch DA, Calabrese LH, Fauci AS, Fries JF, Leavitt RY, Lie JT, Lightfoot RW Jr, Masi AT, et al. The American College of Rheumatology 1990 criteria for the classification of vasculitis. Introduction. Arthritis Rheum. 1990 Aug;33(8):1065-7. doi: 10.1002/art.1780330802. No abstract available.
Fries JF, Hunder GG, Bloch DA, Michel BA, Arend WP, Calabrese LH, Fauci AS, Leavitt RY, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of vasculitis. Summary. Arthritis Rheum. 1990 Aug;33(8):1135-6. doi: 10.1002/art.1780330812. No abstract available.
Jennette JC, Falk RJ, Andrassy K, Bacon PA, Churg J, Gross WL, Hagen EC, Hoffman GS, Hunder GG, Kallenberg CG, et al. Nomenclature of systemic vasculitides. Proposal of an international consensus conference. Arthritis Rheum. 1994 Feb;37(2):187-92. doi: 10.1002/art.1780370206.
Sorensen SF, Slot O, Tvede N, Petersen J. A prospective study of vasculitis patients collected in a five year period: evaluation of the Chapel Hill nomenclature. Ann Rheum Dis. 2000 Jun;59(6):478-82. doi: 10.1136/ard.59.6.478.
Felson DT, Anderson JJ. Methodological and statistical approaches to criteria development in rheumatic diseases. Baillieres Clin Rheumatol. 1995 May;9(2):253-66. doi: 10.1016/s0950-3579(05)80189-x.
Yates M, MacGregor AJ, Robson J, Craven A, Merkel PA, Luqmani RA, Watts RA. The association of vascular risk factors with visual loss in giant cell arteritis. Rheumatology (Oxford). 2017 Apr 1;56(4):524-528. doi: 10.1093/rheumatology/kew397.
Public notes

Contacts
Principal investigator
Name 0 0
Raashid A Luqmani, DM, FRCP(E)
Address 0 0
University of Oxford, United Kingdom
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Raashid A Luqmani
Address 0 0
Country 0 0
Phone 0 0
+44 1865 738106
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01066208