Rheumatoid ArthritisNCT01141413
Dose Escalation With Remicade® and Orencia®
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 5,451 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Commercial health plan members
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Comparison of Dosing and Costs Between Rheumatoid Arthritis Patients Treated With Remicade® Versus Orencia®
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RA patients using Remicade® | Not described | |
| RA patients using Orencia® | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Escalation in dosing amount or frequency
Measured: Throughout follow-up period (variable, between 6 weeks and 39 months)
Secondary outcomes (10)
Switch/discontinuation of index therapy
Measured: Throughout follow-up period (variable, between 6 weeks and 39 months)
Number of infusions
Measured: Throughout follow-up period (variable, between 6 weeks and 39 months)
Average dose per infusion
Measured: Throughout follow-up period (variable, between 6 weeks and 39 months)
Frequency of infusions
Measured: Throughout follow-up period (variable, between 6 weeks and 39 months)
Average costs per infusion
Measured: Throughout follow-up period (variable, between 6 weeks and 39 months)
Health care resource utilization
Measured: Throughout follow-up period (variable, between 6 weeks and 39 months)
Health care costs
Measured: Throughout follow-up period (variable, between 6 weeks and 39 months)
Concurrent medication use
Measured: Throughout follow-up period (variable, between 6 weeks and 39 months)
Time to maximum dose
Measured: Throughout follow-up period (variable, between 6 weeks and 39 months)
Time to dose escalation
Measured: Throughout follow-up period (variable, between 6 weeks and 39 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141413
- Sponsor's protocol ID
- IM101-255
- Status last verified
- Apr 2012
- First submitted
- 9 Jun 2010
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dosing and Costs Between Rheumatoid Arthritis Patients Treated With Remicade® Versus Orencia®
- ClinicalTrials.gov ID
- NCT01141413
- Acronym / sponsor ID
- IM101-255
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,451 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients using Remicade® | – | – |
| RA patients using Orencia® | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Commercial health plan members
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Escalation in dosing amount or frequency
Time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)
10 secondary outcomes
Switch/discontinuation of index therapy
Time frame: 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)
Average dose per infusion
Time frame: 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)
Average costs per infusion
Time frame: 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)
Health care costs
Time frame: 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)
Time to maximum dose
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2012.
- For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htmLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Escalation in dosing amount or frequency (time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2012.