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.

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Non-Interventional

• Study Type: Observational
• Enrollment (Actual): 2052

Contacts and Locations

Study Locations

• Australia
  • Canberra City, Australia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with a diagnosis of rheumatoid arthritis (RA) who have received a TNFi or abatacept and registered in the OPAL registry

Description

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/exclusion criteria could apply

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants RA who have received a TNFi	Other: Non-Interventional; Non-Interventional
Participants with RA who have received abatacept	Other: Non-Interventional; Non-Interventional

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with positive ACPA	ACPA-positive greater than or equal to 5 Ru/mL in Australia, greater than or equal to 20 Ru/mL in US	Index
Number of participants with negative ACPA	ACPA-negative less than or equal to 5 Ru/mL in Australia, less than or equal to 20 Ru/mL in US	Index
CDAI (clinical disease activity index) score	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	Index plus or minus 1 month
CDAI (clinical disease activity index) score	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	12 months plus or minus 3 months
DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score	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.	Index plus or minus 1 month
DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score	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.	12 months plus or minus 3 months
Number of participants with treatment persistence		Approximately 11 years and 5 months
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
Number of participants that achieved remission	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	12 months plus or minus 3 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• Investigator Inquiry Form
• FDA Safety Alerts and Recalls
• BMS (Bristol-Myers Squibb) Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2017
• Primary Completion (Actual): March 5, 2019
• Study Completion (Actual): December 18, 2019

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Necrosis
• Other Study ID Numbers: IM101-728

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No