- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01141413
Dose Escalation With Remicade® and Orencia®
Comparison of Dosing and Costs Between Rheumatoid Arthritis Patients Treated With Remicade® Versus Orencia®
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
RA patients using Remicade®
|
RA patients using Orencia®
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Escalation in dosing amount or frequency
Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Switch/discontinuation of index therapy
Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Number of infusions
Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Average dose per infusion
Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Frequency of infusions
Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Average costs per infusion
Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Health care resource utilization
Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Health care costs
Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Concurrent medication use
Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Time to maximum dose
Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Time to dose escalation
Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Throughout follow-up period (variable, between 6 weeks and 39 months)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IM101-255
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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