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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Non-Interventional

• Registration Number: NCT03663829
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2017-10-04
• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Primary Completion: 2019-03-05
• Study Completion: 2019-12-18
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2052

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

Read More

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/exclusion criteria could apply

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with RA who have received abatacept	Non-Interventional	-
Participants RA who have received a TNFi	Non-Interventional	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score	12 months plus or minus 3 months	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 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
Number of participants with treatment discontinuation	Approximately 11 years and 5 months
Number of participants identified as taking abatacept	Index
Number of participants identified as taking TNFi (tumor necrosis factor inhibitor)	Index
CDAI (clinical disease activity index) score	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 persistence	Approximately 11 years and 5 months
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