Observational Real-world Evaluation of Cost of Infections of Rheumatoid Arthritis (RA) Patients on Biologics

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01166620
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

To quantify the incremental cost of infections in patients treated with etanercept, adalimumab or infliximab versus abatacept.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Primary Completion: 2011-09
• Study Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-12
• Last Update Posted: 2012-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• 18 years of age and older;
• Have a diagnosis of of rheumatoid arthritis (ICD-9:714x.xx);
• Have been enrolled for at least 6 months for the 6 months assessment and 12 months for the 12 months assessment;
• are enrolled in a health plan between February 2006 and June 2009
• have claims indicating at least one use of either abatacept, etanercept, adalimumab or infliximab for at least 6 months for teh 6 months assessment and 12 months for the 12 months assessment

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Exclusion Criteria

• Patients not continuously eligible for health plan benefits for the same evaluation periods will be excluded
• Patients who are on other biologics in the 6 and 12 month post-index period will be excluded (ex. those in the abatacept cohort will be excluded if they also have claims for etanercept in the 6 and 12 month post-index period).
• Patients on biologics 6 months prior to the biologic index date will also be excluded
• Patients with diagnosis for other non-RA conditions commonly treated with biologics (ex. Crohn's disease) during the 6 month pre-index period.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incremental total and component (inpatient, outpatient and pharmacy) direct costs due to infection in patients treated with etanercept, adalimumab or infliximab versus abatacept	6 months
Incremental total and component (inpatient, outpatient and pharmacy) direct costs due to infection in patients treated with etanercept, adalimumab or infliximab versus abatacept.	1 year