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

Bristol-Myers Squibb0 sites4,099 target enrollmentJune 2006

ConditionsRheumatoid Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Enrollment: 4099
Primary Endpoint: 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
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

December 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

Time Frame: Approximately 6 months

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(6 month pre-index and 6 months pre-index date and 12 month post index follow up)