Status:

COMPLETED

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

18+ years

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2012

Estimated Enrollment :

4000 Patients enrolled

Trial Details

Trial ID

NCT01166620

Start Date

June 1 2010

End Date

March 1 2012

Last Update

April 13 2012

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