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 therapyNumber 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
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