Impact of Anti-citrullinated Protein Antibody Status on Treatment Response and Treatment Persistence in Participants With Rheumatoid Arthritis (RA) Who Are Treated With Abatacept or Tumor Necrosis Factor Inhibitors in Australia

Impact of Anti-citrullinated Protein Antibody Status on Treatment Response and Treatment Persistence in Patients With Rheumatoid Arthritis Who Are Treated With Abatacept or Tumour Necrosis Factor Inhibitors. An Analysis From the Optimising Patient Outcome in Australian Rheumatology (OPAL) Registry.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03663829

Enrollment

2052

Registered

2018-09-10

Start date

2017-10-04

Completion date

2019-12-18

Last updated

2022-03-09

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

Conditions

Rheumatoid Arthritis

Brief summary

An observational study assessing the impact of anti-citrullinated antibody (ACPA) in rheumatoid arthritis (RA) participants who have received abatacept or tumour necrosis factor inhibitors (TNFi) from the Optimising Patient outcome in Australian rheumatoLogy (OPAL) registry

Interventions

OTHERNon-Interventional

Non-Interventional

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

Inclusion criteria

* Diagnosed with rheumatoid arthritis * Have a baseline ACPA recorded * Received either abatacept or a TNFi (adalimumab, certolizumab, etanercept or golimumab) during the sample selection window 1 August 2006 to 30 June 2017

Exclusion criteria

* Patients who have died * Patients with concomitant inflammatory diseases (e.g. ankylosing spondylitis, psoriatic arthritis, Crohn's disease, ulcerative colitis) * Patients who have no visit data recorded (even if medication data is available) Other protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame	Description
ACPA (Anti-cyclic citrullinated peptide) status	Pre-Index	ACPA-positive greater than or equal to 5 Ru/mL in Australia, greater than or equal to 20 Ru/mL in US

Secondary

Measure	Time frame	Description
Number of participants with negative ACPA	Index	ACPA-negative less than or equal to 5 Ru/mL in Australia, less than or equal to 20 Ru/mL in US
CDAI (clinical disease activity index) score	Index plus or minus 1 month	Remission CDAI \<2.9 Low disease activity CDAI ≥ 2.9 but \<10.0 Moderate disease activity CDAI ≥ 10.1 but \<22.0 High disease activity CDAI ≥ 22.0
DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score	Index plus or minus 1 month	The DAS-28 CRP-3 is a measure of disease activity in rheumatoid arthritis (RA) that assesses 28 joints in RA commonly affected. The DAS-28 CRP 3 takes into account tender and swollen joint counts and CRP level (measure of inflammation in the blood). The DAS-28 CRP 3 measure does not include patient global assessment of health.
Number of participants with treatment persistence	Approximately 11 years and 5 months	—
Number of participants with positive ACPA	Index	ACPA-positive greater than or equal to 5 Ru/mL in Australia, greater than or equal to 20 Ru/mL in US
Number of participants identified as taking abatacept	Index	—
Number of participants identified as taking TNFi (tumor necrosis factor inhibitor)	Index	—
Number of participants that achieved remission	12 months plus or minus 3 months	Remission CDAI \<2.9 Low disease activity CDAI ≥ 2.9 but \<10.0 Moderate disease activity CDAI ≥ 10.1 but \<22.0 High disease activity CDAI ≥ 22.0
Number of participants with treatment discontinuation	Approximately 11 years and 5 months	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026