Clinical trial NCT02346942: Factors Associated With Biologic DMARD Switching
Official title: Factors Associated With Biologic Disease Modifying Antirheumatic Drugs Switching and Impact of Healthcare Resource Utilization in a Managed Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 4099
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individual patients with RA will be identified using electronic medical records from 01/01/2007 to 10/31/2012. The medical file contains data on diagnostic and therapeutic services rendered in both inpatient and outpatient settings. The diagnoses and procedures for these services are coded using ICD-9-CM, Current Procedural Terminology (CPT), and Diagnosis-Related Group (DRG) codes with service dates.

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Approximately 12 months
measure: 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
timeFrame: Approximately 6 months
measure: Measure the reasons for switching to another bDMARD based on Provider documentation in chart notes
timeFrame: 12 month post index follow up
measure: Measure the reasons for switching to another bDMARD based on Provider documentation in chart notes
timeFrame: 6 months pre-index date
Secondary outcomes:
measure: 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
timeFrame: 6 month pre-index and 6 months pre-index date and 12 month post index follow up
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: