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

NCT03663829 | Completed

• 1 other identifier: IM101-728
• Study Type: observational
• Target: 2,052
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Number of participants with positive ACPA

  Index

• Number of participants with negative ACPA

  Index

• CDAI (clinical disease activity index) score

  Index plus or minus 1 month

• CDAI (clinical disease activity index) score

  12 months plus or minus 3 months

• DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score

  Index plus or minus 1 month

Study Arms (2)

Participants RA who have received a TNFi

Other: Non-Interventional

Participants with RA who have received abatacept

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Non-Interventional

Participants RA who have received a TNFi

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Unknown Facility

Canberra City, Australia

Location

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: October 4, 2017
• Primary Completion: March 5, 2019
• Study Completion: December 18, 2019
• Last Updated: March 9, 2022

Record last verified: 2022-02

Locations

AU (1)