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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01166620
First received: July 19, 2010
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Real-world Evaluation of Cost of Infections of RA Patients on Biologics

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 4000
Study Start Date: June 2010
Study Completion Date: March 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with rheumatoid arthritis new to abatacept.
Patients with rheumatoid arthritis new to etanercept
Patients with rheumatoid arthritis new to adalimumab
Patients with rheumatoid arthritis new to infliximab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Commercial health plan members

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01166620

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01166620     History of Changes
Other Study ID Numbers: IM101-244
Study First Received: July 19, 2010
Last Updated: April 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014