Rheumatoid ArthritisNCT01137838
Changes in the Use of Opioids, Antidepressants, and Benzodiazepines in Rheumatoid Arthritis Patients Treated With Biologic Agents
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
Trial summary
To compare the proportion of rheumatoid arthritis (RA) patients prescribed opioids, benzodiazepines, and antidepressants before versus after starting each of the following biologics: abatacept, infliximab, etanercept, adalimumab, utilizing an administrative claims database. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 1,810 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Commercial insurance claims database
Who may be able to join
- ICD 9 diagnosis RA 714.0
- Documented first biologic prescription ("index" prescription) for abatacept, infliximab, etanercept, or adalimumab
- Continuous therapy (gap between scripts no greater than 150% days supply) for minimum 6 months from index
- Prescription claims data available for 6 months before and 12 months after index biologic prescription
- Continuous eligibility for 6 months before and 12 months after index biologic prescription
Who cannot join
- Prescription claims for another biologic during the observation period (including rituximab and anakinra)
- Prescriptions not continuous for at least 6 months
About this study
To compare the proportion of rheumatoid arthritis (RA) patients prescribed opioids, benzodiazepines, and antidepressants before versus after starting each of the following biologics: abatacept, infliximab, etanercept, adalimumab, utilizing an administrative claims database.
- 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 |
|---|---|---|
| Patients with RA and new to abatacept | Not described | |
| Patients with RA and new to infliximab | Not described | |
| Patients with RA and new to etanercept | Not described | |
| Patients with RA and new to adalimumab | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants
Measured: 0-6 months after index biologic prescription
Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants
Measured: 7-12 months after index biologic prescription
Secondary outcomes (2)
Prevalence of depression and/or anxiety (ICD-9 diagnosis code)
Measured: Between 0-6 months after index biologic prescription
Prevalence of depression and/or anxiety (ICD-9 diagnosis code)
Measured: 7-12 months after index biologic prescription
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 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
- 1,810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137838
- Sponsor's protocol ID
- IM101-238
- Status last verified
- May 2011
- First submitted
- 2 Jun 2010
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Use of Opioids, Antidepressants, and Benzodiazepines in Rheumatoid Arthritis Patients Treated With Biologic Agents
- ClinicalTrials.gov ID
- NCT01137838
- Acronym / sponsor ID
- IM101-238
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,810 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 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.
To compare the proportion of rheumatoid arthritis (RA) patients prescribed opioids, benzodiazepines, and antidepressants before versus after starting each of the following biologics: abatacept, infliximab, etanercept, adalimumab, utilizing an administrative claims database.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with RA and new to abatacept | – | – |
| Patients with RA and new to infliximab | – | – |
| Patients with RA and new to etanercept | – | – |
| Patients with RA and new to adalimumab | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Commercial insurance claims database
Key inclusion criteria (5 listed)
- ICD 9 diagnosis RA 714.0
- Documented first biologic prescription ("index" prescription) for abatacept, infliximab, etanercept, or adalimumab
- Continuous therapy (gap between scripts no greater than 150% days supply) for minimum 6 months from index
- Prescription claims data available for 6 months before and 12 months after index biologic prescription
- Continuous eligibility for 6 months before and 12 months after index biologic prescription
Key exclusion criteria (2 listed)
- Prescription claims for another biologic during the observation period (including rituximab and anakinra)
- Prescriptions not continuous for at least 6 months
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
Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants
Time frame: 0-6 months after index biologic prescription
Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants
Time frame: 7-12 months after index biologic prescription
2 secondary outcomes
Prevalence of depression and/or anxiety (ICD-9 diagnosis code)
Time frame: Between 0-6 months after index biologic prescription
Prevalence of depression and/or anxiety (ICD-9 diagnosis code)
Time frame: 7-12 months after index biologic prescription
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 17 May 2011.
- 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 5 inclusion and 2 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 17 May 2011. 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?
Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants (time frame: 0-6 months after index biologic prescription). The study lists 2 primary outcomes in all. 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 17 May 2011.