Factors Associated With Biologic DMARD Switching

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02346942

Enrollment

4099

Registered

2015-01-27

Start date

2006-06-30

Completion date

2015-12-31

Last updated

2016-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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 12 months	biologic disease modifying anti-rheumatic drug (bDMARD)
Measure the reasons for switching to another bDMARD based on Provider documentation in chart notes	12 month post index follow up	—

Secondary

Measure	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

Outcome results