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The purpose of this study is to evaluate the risk of infections and malignancies among Rheumatoid Arthritis (RA) patients treated with Abatacept compared to other RA treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA patients who are prescribed Abatacept | Abatacept |
| |
| Patients who are prescribed other RA treatments |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Lung Cancer | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug | Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years) |
| Risk of lymphoma | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug | Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years) |
| Risk of breast cancer | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug | Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years) |
| Risk of non-melanoma skin cancer | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug | Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years) |
| Risk of all malignancies | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug | Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years) |
| Risk of hospitalized infections | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of lupus | The index date is defined as the date that the patient initiates Abatacept | Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years) |
| Incidence of multiple sclerosis |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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Patients will be selected from 4 US claims databases
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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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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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year) |
| Risk of pneumonia | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug | Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year) |
| Risk of opportunistic infections | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug | Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year) |
| Risk of tuberculosis | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug | Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year) |
The index date is defined as the date that the patient initiates Abatacept |
| Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years) |
| Incidence of psoriasis | The index date is defined as the date that the patient initiates Abatacept | Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years) |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |