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

NCT ID: NCT03663829

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2052 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-04

Study Completion Date

2019-12-18

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants RA who have received a TNFi

Non-Interventional

Intervention Type OTHER

Non-Interventional

Participants with RA who have received abatacept

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

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Non-Interventional

Non-Interventional

Intervention Type OTHER

Non-Interventional

Non-Interventional

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Canberra City, , Australia

Site Status

Countries

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Australia

Related Links

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Other Identifiers

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IM101-728

Identifier Type: -

Identifier Source: org_study_id

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