Factors Associated With Biologic DMARD Switching

Study Overview
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Brief Summary
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The Primary objective of this study is to understand the rheumatoid arthritis (RA) population in national integrated delivery network who are treated with first- or second-line biologic disease modifying anti-rheumatic drug (bDMARD) therapy (with or without Methotrexate) and to evaluate switching patterns and reasons for switching to another bDMARD.

Official Title
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Factors Associated With Biologic Disease Modifying Antirheumatic Drugs Switching and Impact of Healthcare Resource Utilization in a Managed Care Setting

Conditions
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Rheumatoid Arthritis

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: Diagnosis of RA (ICD-9 714.xx) anytime during the study time period of 1/1/2007 to 10/31/2012 Patients ≥18 years of age at diagnosis date Required to have to have 6 months pre-index and 12 months post-index continuous membership and drug benefit eligibility in the database Exclusion Criteria: Patients less than 18 years of age on diagnosis date If they had a diagnosis of Crohn's disease, psoriasis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, regional enteritis, or anal fistula during the pre-index period Patients who had <7 days supply of adalimumab or etanercept Patients currently in a clinical trial during our study If patients are in the second-line cohort and have more than 1 prior bDMARD

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 |
| --- | --- |
| Patients who have no history of bDMARD therapy use<br> | |
| Patients who have a prior history of bDMARD therapy use<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the change in population of patients who are treated with first- or second-line bDMARD therapy (with or without Methotrexate) to another bDMARD therapy | biologic disease modifying anti-rheumatic drug (bDMARD) | Approximately 12 months | 
| Measure the change in population of patients who are treated with first- or second-line bDMARD therapy (with or without Methotrexate) to another bDMARD therapy |  | Approximately 6 months | 
| Measure the reasons for switching to another bDMARD based on Provider documentation in chart notes |  | 12 month post index follow up | 
| Measure the reasons for switching to another bDMARD based on Provider documentation in chart notes |  | 6 months pre-index date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate RA related and all cause healthcare resource utilization of doctor visits, hospitalizations and ER visits as patients switch bDMARDs measured from Patient heath claims data from KPSC integrated healthcare data |  | 6 month pre-index and 6 months pre-index date and 12 month post index follow up |