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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants RA who have received a TNFi |
| ||
| Participants with RA who have received abatacept |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Non-Interventional |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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Patients with a diagnosis of rheumatoid arthritis (RA) who have received a TNFi or abatacept and registered in the OPAL registry
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canberra City | Australia |
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| Label | URL |
|---|---|
| BMS (Bristol-Myers Squibb) Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| Non-Interventional |
| Other |
Non-Interventional |
|
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 |
| View source |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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