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

Study Overview
=================
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

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.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: Non-Interventional
* Other: Non-Interventional


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants RA who have received a TNFi<br> | Other: Non-Interventional<br>* Non-Interventional<br>|
| Participants with RA who have received abatacept<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

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 |