The application of anti-cyclic citrullinated peptide autoantibody and soluble HLA-DR tests to the detection of early rheumatoid arthritis in New Zealand patients.

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12606000277549

Enrollment

Registered

2006-07-03

Start date

2004-08-09

Completion date

2013-08-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

Patients with undifferentiated arthritis will be observed for a minimum of 2 years

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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.

Outcome results