Factors Associated With Biologic DMARD Switching

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346942
• Other study ID #: IM101-474
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: February 3, 2016
• Start date: June 2006
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4099
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Approximately 12 months	No
Primary	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	No
Primary	Measure the reasons for switching to another bDMARD based on Provider documentation in chart notes		12 month post index follow up	No
Primary	Measure the reasons for switching to another bDMARD based on Provider documentation in chart notes		6 months pre-index date	No
Secondary	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	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
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