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

Observational Real-world Evaluation of Cost of Infections of RA Patients on Biologics

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01166620
Enrollment
4000
Registered
2010-07-21
Start date
2010-06-30
Completion date
2012-03-31
Last updated
2012-04-13

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

Conditions

Rheumatoid Arthritis

Brief summary

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

Interventions

None listed

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Design outcomes

Primary

MeasureTime frame
Incremental total and component (inpatient, outpatient and pharmacy) direct costs due to infection in patients treated with etanercept, adalimumab or infliximab versus abatacept6 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026