Dose Escalation With Remicade® and Orencia®

Rheumatoid Arthritis Clinical Trial

Official title:

Comparison of Dosing and Costs Between Rheumatoid Arthritis Patients Treated With Remicade® Versus Orencia®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141413
• Other study ID #: IM101-255
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: April 3, 2012
• Start date: January 2010
• Est. completion date: August 2010

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

The purpose of this study is to describe infliximab and abatacept dosing patterns (i.e., dosing amount and frequency) and costs among a population of managed care enrollees with RA. This study will also identify changes in infliximab and abatacept dosing over time and the implication these changes may have on the costs of medication administration.

Description:

This study will be conducted in two parts. The primary analysis is a longitudinal analysis, where patients' health care claims from a period during which the patient was continuously enrolled in the health plan will be used to evaluate the primary outcome (i.e., dose escalation). The second analysis will be cross-sectional, where patients' health care claims from a fixed period of time (i.e., 2008) will be used to examine health care cost.

The final enrollment for the longitudinal portion of the study was 2,001 (1,306 infliximab and 695 abatacept patients). Final enrollment for the cross-sectional portion was 3,450 (2,646 infliximab and 806 abatacept patients). There may be some overlap in these numbers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5451
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Commercial health plan enrollees with medical and pharmacy coverage

• At least 3 claims on separate days for infliximab (HCPCS J1745) or abatacept (HCPCS C9230, J0129, J3590) administration during the subject identification period

• The 3 initial claims for abatacept occurred within a 6-week period inclusive of the index date and the three initial claims for infliximab occur within a 9-week period inclusive of the index date

• Presence of a diagnosis of RA (ICD-9-CM 714.xx)

• Continuous enrollment during the baseline and follow-up periods

• At least 18 years of age or older on the index date

Exclusion Criteria:

• Prior exposure to the index medication during the baseline period

• Diagnosis of psoriasis (ICD-9-CM 696.1), psoriatic arthritis (696.0), ankylosing spondylitis (720.0), Crohn's disease (555.x), or ulcerative colitis (556.x) in any position at any time during the study period

• Exposure to alefacept (HCPCS J0215, C9211, C9212) or efalizumab (HCPCS S0162) at any time during the study 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	Escalation in dosing amount or frequency		Throughout follow-up period (variable, between 6 weeks and 39 months)	No
Secondary	Switch/discontinuation of index therapy		Throughout follow-up period (variable, between 6 weeks and 39 months)	No
Secondary	Number of infusions		Throughout follow-up period (variable, between 6 weeks and 39 months)	No
Secondary	Average dose per infusion		Throughout follow-up period (variable, between 6 weeks and 39 months)	No
Secondary	Frequency of infusions		Throughout follow-up period (variable, between 6 weeks and 39 months)	No
Secondary	Average costs per infusion		Throughout follow-up period (variable, between 6 weeks and 39 months)	No
Secondary	Health care resource utilization		Throughout follow-up period (variable, between 6 weeks and 39 months)	No
Secondary	Health care costs		Throughout follow-up period (variable, between 6 weeks and 39 months)	No
Secondary	Concurrent medication use		Throughout follow-up period (variable, between 6 weeks and 39 months)	No
Secondary	Time to maximum dose		Throughout follow-up period (variable, between 6 weeks and 39 months)	No
Secondary	Time to dose escalation		Throughout follow-up period (variable, between 6 weeks and 39 months)	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