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

• ClinicalTrials.gov Identifier: NCT03663829
• Recruitment Status: Completed
• First Posted: September 10, 2018
• Last Update Posted: March 9, 2022
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

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

Condition or disease	Intervention/treatment
Rheumatoid Arthritis	Other: Non-Interventional

Study Design

• Study Type: Observational
• Actual Enrollment: 2052 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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.
• Actual Study Start Date: October 4, 2017
• Actual Primary Completion Date: March 5, 2019
• Actual Study Completion Date: December 18, 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. ACPA (Anti-cyclic citrullinated peptide) status [ Time Frame: 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 :

1. Number of participants with positive ACPA [ Time Frame: Index ]
   ACPA-positive greater than or equal to 5 Ru/mL in Australia, greater than or equal to 20 Ru/mL in US
2. Number of participants with negative ACPA [ Time Frame: Index ]
   ACPA-negative less than or equal to 5 Ru/mL in Australia, less than or equal to 20 Ru/mL in US
3. CDAI (clinical disease activity index) score [ Time Frame: 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
4. CDAI (clinical disease activity index) score [ Time Frame: 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
5. DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score [ Time Frame: 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.
6. DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score [ Time Frame: 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.
7. Number of participants with treatment persistence [ Time Frame: Approximately 11 years and 5 months ]
8. Number of participants with treatment discontinuation [ Time Frame: Approximately 11 years and 5 months ]
9. Number of participants identified as taking abatacept [ Time Frame: Index ]
10. Number of participants identified as taking TNFi (tumor necrosis factor inhibitor) [ Time Frame: Index ]
11. Number of participants that achieved remission [ Time Frame: 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Australia

Canberra City, Australia

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

BMS (Bristol-Myers Squibb) Clinical Trial Information 

Investigator Inquiry Form 

FDA Safety Alerts and Recalls 

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03663829
• Other Study ID Numbers: IM101-728
• First Posted: September 10, 2018
• Last Update Posted: March 9, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Necrosis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes