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A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants taking abatacept |
| ||
| Participants taking abatacept with methotrexate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Non-Interventional |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of increased risk of serious infection while taking abatacept | With methotrexate | Approximately 7 years |
| Incidence of malignancy while taking abatacept | With methotrexate | Approximately 7 years |
| Incidence of increased risk of serious infection while taking abatacept | Without methotrexate | Approximately 7 years |
| Incidence of malignancy while taking abatacept | Without methotrexate | Approximately 7 years |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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Rheumatoid arthritis (RA) participant, population-based cohort study approach within the US-based Truven MarketScan population and Supplemental US Medicare database
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Princeton | New Jersey | 08540 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Non-Interventional |
| Other |
Non-Interventional |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |