ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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 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]

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

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

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]

Not applicable

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

For patients with undifferentiated inflammatory arthritis development of rheumatoid arthritis as defined by American College of Rheumatology Classification Criteria for rheumatoid arthritis

Timepoint [1]

2 years

Primary outcome [2]

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]

annually for at least 10 years

Secondary outcome [1]

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]

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?

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]

New Zealand

State/province [1]

Christchurch

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

University of Otago

Address

2 Riccarton Ave
Christchurch

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Upper South A Regional Ethics Committee

Ethics committee address [1]

Ministry of Health
POBox 3877
Christchurch

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

13/03/2006

Ethics approval number [1]

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

Prof Lisa Stamp

Address

Department of Medicine
P.O.Box 4345
Christchurch 8014

Country

New Zealand

Phone

+6433640953

Fax

lisa.stamp@cdhb.govt.nz

Contact person for public queries

Name

Lisa Stamp

Address

Department of Medicine
POBox 4345
Christchurch

Country

New Zealand

Phone

+6433640953

Fax

lisa.stamp@cdhb.govt.nz

Contact person for scientific queries

Name

Lisa Stamp

Address

Department of Medicine
POBox 4345
Christchurch

Country

New Zealand

Phone

64-3-364-0953

Fax

lisa.stamp@cdhb.govt.nz

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Comparison 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.	2012	https://dx.doi.org/10.3899/jrheum.120226

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically