Trial Review

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
ACTRN12608000292370
Ethics application status
Approved
Date submitted
3/06/2008
Date registered
12/06/2008
Date last updated
12/11/2018
Date data sharing statement initially provided
12/11/2018
Date results information initially provided
12/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Novel markers in the diagnosis and prognosis of Rheumatoid arthritis
Scientific title
Novel markers in the diagnosis and prognosis of Rheumatoid arthritis
Secondary ID [1] 283061 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Undifferentiated inflammatory arthritis and rheumatoid arthritis 3222 0
Condition category
Condition code
Inflammatory and Immune System 3387 3387 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study only. In patients with undifferentiated inflammatory arthritis this study observes what type of arthritis may develop over time. In addition we will observe whether patients who present with undifferentiated inflammatory arthritis have better or worse long-term outcomes than those with rheuamtoid arthritis. For patients with rheumatoid arthritis we are observing lon-term disease outcomes. Duration of study at least 10 years.
Intervention code [1] 2963 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4282 0
For patients with undifferentiated inflammatory arthritis development of rheumatoid arthritis as defined by American College of Rheumatology Classification Criteria for rheumatoid arthritis
Timepoint [1] 4282 0
2 years
Primary outcome [2] 4283 0
For patients with rheumatoid arthritis - disease severity will be assessed by a number of factors including, number of swollen and tender joints, radiologically evidence of joint damage, requirement for joint surgery, mortality and function
Timepoint [2] 4283 0
annually for at least 10 years
Secondary outcome [1] 7215 0
For patients with Undifferentiated inflammatory arthritis disease severity will be assessed by a number of criteria including disease severity will be assessed by a number of factors including, number of swollen and tender joints, radiologically evidence of joint damage, requirement for joint surgery, mortality and function
Timepoint [1] 7215 0
yearly for at least 10 years

Eligibility
Key inclusion criteria
Patients with undifferentiated inflammatory arthritis or rheumatoid arthritis will be invited to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe uncontrolled concomitant health problems

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2008
Actual
12/05/2006
Date of last participant enrolment
Anticipated
Actual
3/03/2014
Date of last data collection
Anticipated
Actual
26/09/2014
Sample size
Target
200
Accrual to date
Final
162
Recruitment outside Australia
Country [1] 996 0
New Zealand
State/province [1] 996 0
Christchurch

Funding & Sponsors
Funding source category [1] 3446 0
Self funded/Unfunded
Name [1] 3446 0
Country [1] 3446 0
Primary sponsor type
University
Name
University of Otago
Address
2 Riccarton Ave
Christchurch
Country
New Zealand
Secondary sponsor category [1] 3089 0
None
Name [1] 3089 0
Address [1] 3089 0
Country [1] 3089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5473 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 5473 0
Ministry of Health
POBox 3877
Christchurch
Ethics committee country [1] 5473 0
New Zealand
Date submitted for ethics approval [1] 5473 0
Approval date [1] 5473 0
13/03/2006
Ethics approval number [1] 5473 0
Ethics ref: URB06/03/017

Summary
Brief summary
The most common forms of inflammatory arthritis are rheumatoid arthritis (RA), spondyloarthritis (psoriatic arthritis, ankylosing spondylitis, reactive arthritis) or crystal arthritis (gout). In many patients who present with acute arthritis it is not possible to determine the definite type of arthritis for some time. One of the challenges in early arthritis is to determine who will develop a chronic destructive type of arthritis such as RA, which leads to pain, suffering, and frequently irreversible joint damage. Earlier identification and treatment of patients with RA can reduce permanent joint damage. However, identifying patients with early RA, as opposed to other forms of arthritis can be difficult. Current diagnostic tests for RA are limited to those that detect joint changes after the disease is well established. We currently have an Early arthritis study (CTR/04/06/095) investigating novel markers in patients with early inflammatory arthritis. We wish to identify whether the novel markers in patients with undifferentiated arthritis are present in those with defined forms of arthritis such as rheumatoid arthritis, psoriatic arthritis or osteoarthritis and thus may help in diagnosis of these conditions. We therefore require a cohort of samples from patients with a specific diagnosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28639 0
Prof Lisa Stamp
Address 28639 0
Department of Medicine
P.O.Box 4345
Christchurch 8014
Country 28639 0
New Zealand
Phone 28639 0
+6433640953
Fax 28639 0
Email 28639 0
[email protected]
Contact person for public queries
Name 11796 0
Prof Lisa Stamp
Address 11796 0
Department of Medicine
POBox 4345
Christchurch
Country 11796 0
New Zealand
Phone 11796 0
+6433640953
Fax 11796 0
Email 11796 0
[email protected]
Contact person for scientific queries
Name 2724 0
Prof Lisa Stamp
Address 2724 0
Department of Medicine
POBox 4345
Christchurch
Country 2724 0
New Zealand
Phone 2724 0
64-3-364-0953
Fax 2724 0
Email 2724 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 127. R Raja, P Chapman, J O’Donnell, J Ipenburg, C... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComparison of the 2010 American College of Rheumatology/European League against Rheumatism and the 1987 American Rheumatism Association classification criteria for rheumatoid arthritis in an early arthritis cohort in New Zealand.2012https://dx.doi.org/10.3899/jrheum.120226
N.B. These documents automatically identified may not have been verified by the study sponsor.