Post-marketing Study Assessing the Long-Term Safety of Abatacept

Study Overview
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Brief Summary
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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.

Official Title
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Post-marketing Study Assessing the Long-Term Safety of Abatacept

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Abatacept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA patients who are prescribed Abatacept<br>Abatacept | Drug: Abatacept<br> <br> |
| Patients who are prescribed other RA treatments<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |