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OpenTrials
Completed

NCT Number: NCT01166620

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 21, 2010
Registry last updated
Apr 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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