Rheumatoid Arthritis Clinical Trial
Official title:
Comparison of Dosing and Costs Between Rheumatoid Arthritis Patients Treated With Remicade® Versus Orencia®
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 |
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.
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
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 |
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