Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000012370
Ethics application status
Approved
Date submitted
31/12/2007
Date registered
10/01/2008
Date last updated
20/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Canterbury anti-neutropil cytoplasmic antibody (ANCA) associated vasculitis observational study
Scientific title
Long-term disease outcomes including organ damage and predictors of disease flare in anti-neutropil cytoplasmic antibody (ANCA) associated vasculitis
Secondary ID [1] 287703 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anti-neutropil cytoplasmic antibody (ANCA) associated vasculitidies including Wegeners granulomatosis (WG) 2664 0
Condition category
Condition code
Inflammatory and Immune System 2784 2784 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
ANCA associated vasculitidies are rare conditions with significant morbidity. We will observe patients indefinitely to determine long-term disease outcomes and predictors of disease relapse
Intervention code [1] 2405 0
Not applicable
Comparator / control treatment
Not applicable observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3669 0
This is an observational study of disease outcomes. Participants will be assessed using a variety of meausres including the SF36, Bath vasculitis activity score for wegeners granulomatosis (BVASWG), vasculitis damage index (VDI) and the disease extent index (DEI).
Timepoint [1] 3669 0
Patients will be followed indefinitely to determine long term outcomes. Patients will be seen at least 3-6 monthly
Primary outcome [2] 3685 0
Response to and complications from therapy. Clinical and laboratory measures will be used to determine complications including bone marrow suppression and infectio rates
Timepoint [2] 3685 0
Patients will be followed indefinitely to determine long term outcomes. Patients will be seen at least 3-6 monthly
Secondary outcome [1] 6200 0
Disease relapse
Timepoint [1] 6200 0
Patients will be followed indefinitely to determine long term outcomes. Patients will be seen at least 3-6monthly

Eligibility
Key inclusion criteria
ANCA associated vasculitis defined by American College of Rheumatology (ACR), Chapel Hill Consensus Criteria or Watts 2007 algorithm
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
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 717 0
New Zealand
State/province [1] 717 0

Funding & Sponsors
Funding source category [1] 2921 0
Other
Name [1] 2921 0
Canterbury Rheumatology Immunology Research Trust
Country [1] 2921 0
New Zealand
Primary sponsor type
Individual
Name
Lisa Stamp
Address
Deparment of Medicine
P.O.Box 4345
Christchurch
Country
New Zealand
Secondary sponsor category [1] 2638 0
Individual
Name [1] 2638 0
Dr John O'Donnell
Address [1] 2638 0
Department of Rheumatology Immunology and Allergy
Canterbury Health Laboratories
P.O.Box 151
Christchurch
Country [1] 2638 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4865 0
New Zealand Upper South A Ethics Committee.
Ethics committee address [1] 4865 0
Ministry of Health
P.O. Box 3877
Christchurch
Ethics committee country [1] 4865 0
New Zealand
Date submitted for ethics approval [1] 4865 0
Approval date [1] 4865 0
03/12/2007
Ethics approval number [1] 4865 0
URA/07/10/076

Summary
Brief summary
Wegener’s Granulomatosis (WG) and WG-like diseases affect the small/medium sized blood vessels. In Canterbury the prevalence of WG is one of the highest in the world. Despite this, we are reliant on information from the Northern Hemisphere to guide us on outcomes and treatments. Whether there are differences in disease severity, prognostic markers and treatment response between the Northern and Southern Hemispheres is unknown. We wish to undertake an observational study of WG patients in Canterbury to characterise the clinical characteristics, treatments and outcomes and compare them to those in the Northern Hemisphere. In addition we will evaluate whether novel markers in the blood and urine help predict disease relapse. Although WG is a rare condition, the severity, chronicity and treatments have a significant impact on those affected. The ability to better predict disease relapse will potentially avoid exposure to harmful treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28266 0
Prof Lisa Stamp
Address 28266 0
Department of Medicine
University of Otago, Christchurch
POBox 4345
Christchurch 8014
Country 28266 0
New Zealand
Phone 28266 0
+64 3 364 0253
Fax 28266 0
Email 28266 0
[email protected]
Contact person for public queries
Name 11423 0
Prof Lisa Stamp
Address 11423 0
Department of Medicine
P.O.Box 4345
Christchurch
Country 11423 0
New Zealand
Phone 11423 0
+64 3 364 0253
Fax 11423 0
+64 3 3640935
Email 11423 0
[email protected]
Contact person for scientific queries
Name 2351 0
Prof Lisa Stamp
Address 2351 0
Department of Medicine
P.O.Box 4345
Christchurch
Country 2351 0
New Zealand
Phone 2351 0
+ 64 3 3640 253
Fax 2351 0
+64 3 3640935
Email 2351 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.