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

NCT01166620 | Completed

• 1 other identifier: IM101-244
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Commercial health plan members

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 13, 2012

Record last verified: 2012-04