Factors Associated With Biologic DMARD Switching

Bristol-Myers Squibb4,099 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

4,099

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: Approximately 6 months

Measure the reasons for switching to another bDMARD based on Provider documentation in chart notes

Time frame: 12 month post index follow up

Measure the reasons for switching to another bDMARD based on Provider documentation in chart notes

Time frame: 6 months pre-index date

Secondary Outcomes

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

Time frame: 6 month pre-index and 6 months pre-index date and 12 month post index follow up

Data from ClinicalTrials.gov

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