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

Rheumatoid Arthritis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663829
• Other study ID #: IM101-728
• Status: Completed
• Start date: October 4, 2017
• Est. completion date: December 18, 2019

Study information

• Verified date: February 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2052
• Est. completion date: December 18, 2019
• Est. primary completion date: March 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Necrosis
• Rheumatoid Arthritis

Intervention

Other:
• Non-Interventional
Non-Interventional
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of participants with treatment persistence		Approximately 11 years and 5 months
Secondary	Number of participants with treatment discontinuation		Approximately 11 years and 5 months
Secondary	Number of participants identified as taking abatacept		Index
Secondary	Number of participants identified as taking TNFi (tumor necrosis factor inhibitor)		Index
Secondary	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

External Links

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