Factors Associated With Biologic DMARD Switching

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02346942
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-27
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4099

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	6 months pre-index date

Secondary Outcome Measures

Name	Time	Method
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