Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000277549
Ethics application status
Approved
Date submitted
30/06/2006
Date registered
3/07/2006
Date last updated
24/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The application of anti-cyclic citrullinated peptide autoantibody and soluble HLA-DR tests to the detection of early rheumatoid arthritis in New Zealand patients.
Scientific title
The application of anti-cyclic citrullinated peptide autoantibody (anti-CCP) and soluble HLA-DR tests to the detection of early rheumatoid arthritis (RA) in New Zealand patients.
Secondary ID [1] 287702 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 1252 0
Condition category
Condition code
Inflammatory and Immune System 1338 1338 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with undifferentiated arthritis will be observed for a minimum of 2 years
Intervention code [1] 1184 0
Early detection / Screening
Intervention code [2] 293094 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1824 0
Diagnosis of RA
Timepoint [1] 1824 0
At 2 years
Secondary outcome [1] 3191 0
Nil
Timepoint [1] 3191 0
Nil

Eligibility
Key inclusion criteria
1. Patients who have been assessed by a rheumatologist and deemed to have undifferentiated inflammatory arthritis defined as history, examination and laboratory findings suggesting an inflammatory disorder, but which are not diagnostic of or classifiable as a specific rheumatic inflammatory condition 2. willing and able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of chronic infection or other severe concomitant medical illness or psychiatric disease.2. Pregnant or breast-feeding females and female subjects of child bearing age who are not practising medically approved methods of contraception.3. HIV positive patients4. History of drug abuse that would interfere with the ability to comply with the study protocol5. Patients with active, concomitant malignancies.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2004
Actual
9/08/2004
Date of last participant enrolment
Anticipated
Actual
30/08/2013
Date of last data collection
Anticipated
Actual
28/08/2015
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 372 0
New Zealand
State/province [1] 372 0
Christchurch

Funding & Sponsors
Funding source category [1] 1463 0
Charities/Societies/Foundations
Name [1] 1463 0
Arthritis New Zealand
Country [1] 1463 0
New Zealand
Primary sponsor type
Individual
Name
Lisa Stamp
Address
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8014
Country
New Zealand
Secondary sponsor category [1] 1292 0
None
Name [1] 1292 0
Address [1] 1292 0
Country [1] 1292 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2843 0
Christchurch
Ethics committee address [1] 2843 0
Ethics committee country [1] 2843 0
New Zealand
Date submitted for ethics approval [1] 2843 0
Approval date [1] 2843 0
12/07/2004
Ethics approval number [1] 2843 0
CTR/04/06/095

Summary
Brief summary
Most patients who present with acute arthritis or inflammation of the joints do not develop rheumatoid arthritis. Rheumatoid arthritis (RA) is a progressive, disabling disease, which results from chronic inflammation in the joints. It 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 self-limiting forms of arthritis can be difficult. Current diagnostic tests for RA are limited to those that can detect joint changes after the disease is well established. This study investigates whether two recently developed tests can help predict those patients presenting with arthritis who will go on to develop RA. These tests involve detection of two antibodies, anti-cyclic citrullinated peptide (CCP) and soluble HLA (sHLA-DR) in blood and joint fluid. Determining patients with early RA will help prevent exposing patients with other self-liming forms of arthritis to potentially toxic medications. In addition identifying patients who are likely to develop more severe RA may help guide more intensive therapy early
Trial website
Trial related presentations / publications
there are no presentations and publications relevant to this study to date
Public notes

Contacts
Principal investigator
Name 35870 0
Prof Lisa Stamp
Address 35870 0
Department of Medicine
University of Otago, Christchurch
POBox 4345
Christchurch 8014
Country 35870 0
New Zealand
Phone 35870 0
+64 3 364 0253
Fax 35870 0
Email 35870 0
[email protected]
Contact person for public queries
Name 10373 0
Prof Lisa Stamp
Address 10373 0
Department of Medicine
P.O.Box 4345
christchurch
Country 10373 0
New Zealand
Phone 10373 0
+64 3 364 0253
Fax 10373 0
Email 10373 0
[email protected]
Contact person for scientific queries
Name 1301 0
Prof Lisa Stamp
Address 1301 0
Department of Medicine
P.O.Box 4345
christchurch
Country 1301 0
New Zealand
Phone 1301 0
+64 3 364 0253
Fax 1301 0
Email 1301 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.