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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166620
• Other study ID #: IM101-244
• Status: Completed
• Phase: N/A
• First received: July 19, 2010
• Last updated: April 12, 2012
• Start date: June 2010
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: March 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form