Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
DRUGAbatacept
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Patient has at least two claims for RA (714.xx) in the 180 days prior to and including the index date (baseline period) * Patient is aged 18 years or older on the index date * Patient was enrolled in the database for at least 180 days before the index date * Patient is newly prescribed Abatacept or another RA treatment and has at least two claims for the treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of tuberculosis | 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 or a comparison anti-rheumatic drug |
| Risk of hospitalized infections | 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 or a comparison anti-rheumatic drug |
| Risk of pneumonia | 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 or a comparison anti-rheumatic drug |
| Risk of opportunistic infections | 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 or a comparison anti-rheumatic drug |
| Risk of Lung Cancer | 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) | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug |
| Risk of lymphoma | 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) | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug |
| Risk of breast cancer | 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) | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug |
| Risk of non-melanoma skin cancer | 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) | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug |
| Risk of all malignancies | 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) | The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of multiple sclerosis | 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) | The index date is defined as the date that the patient initiates Abatacept |
| Incidence of psoriasis | 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) | The index date is defined as the date that the patient initiates Abatacept |
| Incidence of lupus | 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) | The index date is defined as the date that the patient initiates Abatacept |
Outcome results
None listed