Dose Escalation With Remicade® and Orencia®
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01141413
First received: June 9, 2010
Last updated: April 3, 2012
Last verified: April 2012
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Purpose
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.
| Condition |
|---|
|
Rheumatoid Arthritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Comparison of Dosing and Costs Between Rheumatoid Arthritis Patients Treated With Remicade® Versus Orencia® |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Escalation in dosing amount or frequency [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Switch/discontinuation of index therapy [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
- Number of infusions [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
- Average dose per infusion [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
- Frequency of infusions [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
- Average costs per infusion [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
- Health care resource utilization [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
- Health care costs [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
- Concurrent medication use [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
- Time to maximum dose [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
- Time to dose escalation [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
| Enrollment: | 5451 |
| Study Start Date: | January 2010 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| RA patients using Remicade® |
| RA patients using Orencia® |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Commercial health plan members
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01141413 History of Changes |
| Other Study ID Numbers: | IM101-255 |
| Study First Received: | June 9, 2010 |
| Last Updated: | April 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Infliximab Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013