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Dose Escalation With Remicade® and Orencia®

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Phase: N/A

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: Escalation in dosing amount or frequency

Secondary outcome:

Switch/discontinuation of index therapy

Number of infusions

Average dose per infusion

Frequency of infusions

Average costs per infusion

Health care resource utilization

Health care costs

Concurrent medication use

Time to maximum dose

Time to dose escalation

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

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

Starting date: January 2010
Last updated: April 3, 2012

Page last updated: August 23, 2015

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