ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Rheumatoid arthritis

Condition category

Condition code

Inflammatory and Immune System

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]

Early detection / Screening

Intervention code [2]

Diagnosis / Prognosis

Comparator / control treatment

No comparator.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Diagnosis of RA

Timepoint [1]

At 2 years

Secondary outcome [1]

Nil

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Christchurch

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Arthritis New Zealand

Address [1]

Level 2, 166 Featherston Street Wellington 6011

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Christchurch

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

12/07/2004

Ethics approval number [1]

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

Prof Lisa Stamp

Address

Department of Medicine University of Otago, Christchurch POBox 4345 Christchurch 8014

Country

New Zealand

Phone

+64 3 364 0253

Fax

[email protected]

Contact person for public queries

Name

Lisa Stamp

Address

Department of Medicine P.O.Box 4345 christchurch

Country

New Zealand

Phone

+64 3 364 0253

Fax

[email protected]

Contact person for scientific queries

Name

Lisa Stamp

Address

Department of Medicine P.O.Box 4345 christchurch

Country

New Zealand

Phone

+64 3 364 0253

Fax

[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.

Trial Review

Documents added manually

Documents added automatically