Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000619741
Ethics application status
Approved
Date submitted
23/05/2013
Date registered
29/05/2013
Date last updated
16/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational study of the incidence, prevalence and clinical outcomes of primary vasculitis in New Zealand
Scientific title
Incidence, Prevalence, biomarkers and clinical outcomes of primary vasculitis
Secondary ID [1] 282488 0
NIL
Universal Trial Number (UTN)
Trial acronym
NZVASC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vasculitis 289124 0
Condition category
Condition code
Inflammatory and Immune System 289463 289463 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Disease outcomes including death, internal organ involvement, and treatment side effects will be collected for up to 20 years
Intervention code [1] 287140 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289652 0
Incidence of vasulitis in NZ will be calculated as the number of newly diagnosed patients within 1, 5 and 10 years.
Timepoint [1] 289652 0
1, 5 and 10 years
Primary outcome [2] 289653 0
Disease outcomes in vasculitis will be assessed using validated scores: Vasculitis Disease Index, Birmingham Vasculitis Activity Score, Disease Extent Index
Timepoint [2] 289653 0
5 years
Secondary outcome [1] 302960 0
Treatments required for vasculitis in NZ will be assessed by names of specific drugs
Timepoint [1] 302960 0
up to 20 years

Eligibility
Key inclusion criteria
Physician diagnosed vasculitis
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/02/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 5080 0
New Zealand
State/province [1] 5080 0
all

Funding & Sponsors
Funding source category [1] 287271 0
Self funded/Unfunded
Name [1] 287271 0
Country [1] 287271 0
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
P.O.Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 286024 0
None
Name [1] 286024 0
Address [1] 286024 0
Country [1] 286024 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289251 0
University of Otago Ethics Committee
Ethics committee address [1] 289251 0
Academic Services
P.O. Box 56
Dunedin 9016
Ethics committee country [1] 289251 0
New Zealand
Date submitted for ethics approval [1] 289251 0
06/06/2013
Approval date [1] 289251 0
19/07/2013
Ethics approval number [1] 289251 0
H13/022

Summary
Brief summary
This longitudinal study of vasculitis in New Zealand aims to determine the incidence, prevalence, outcomes and risk factors for vasculitis in New Zealand
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39978 0
Prof Lisa Stamp
Address 39978 0
Department of Medicine
University of Otago, Christchurch
P.O.Box4345
Christchurch 8014
Country 39978 0
New Zealand
Phone 39978 0
+64-3-364-0953
Fax 39978 0
Email 39978 0
[email protected]
Contact person for public queries
Name 39979 0
John O'Donnell
Address 39979 0
Department of Rheumatology Immunology and Allergy
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 39979 0
New Zealand
Phone 39979 0
+64-3-364-0950
Fax 39979 0
Email 39979 0
[email protected]
Contact person for scientific queries
Name 39980 0
John O'Donnell
Address 39980 0
Department of Rheumatology Immunology and Allergy
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 39980 0
New Zealand
Phone 39980 0
+64-3-364-0950
Fax 39980 0
Email 39980 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.