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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA patients using Remicade® | |||
| RA patients using Orencia® |
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| Measure | Description | Time Frame |
|---|---|---|
| Escalation in dosing amount or frequency | Throughout follow-up period (variable, between 6 weeks and 39 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Switch/discontinuation of index therapy | Throughout follow-up period (variable, between 6 weeks and 39 months) | |
| Number of infusions | Throughout follow-up period (variable, between 6 weeks and 39 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Commercial health plan members
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Label | URL |
|---|---|
| BMS Clinical Trials Disclosure | View source |
| For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Average dose per infusion | Throughout follow-up period (variable, between 6 weeks and 39 months) |
| Frequency of infusions | Throughout follow-up period (variable, between 6 weeks and 39 months) |
| Average costs per infusion | Throughout follow-up period (variable, between 6 weeks and 39 months) |
| Health care resource utilization | Throughout follow-up period (variable, between 6 weeks and 39 months) |
| Health care costs | Throughout follow-up period (variable, between 6 weeks and 39 months) |
| Concurrent medication use | Throughout follow-up period (variable, between 6 weeks and 39 months) |
| Time to maximum dose | Throughout follow-up period (variable, between 6 weeks and 39 months) |
| Time to dose escalation | Throughout follow-up period (variable, between 6 weeks and 39 months) |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |