Rheumatoid Arthritis Clinical Trial
Official title:
Changes in the Use of Opioids, Antidepressants, and Benzodiazepines in Rheumatoid Arthritis Patients Treated With Biologic Agents
Verified date | May 2011 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: No Health Authority |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1810 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Prescription claims for another biologic during the observation period (including rituximab and anakinra) - Prescriptions not continuous for at least 6 months |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants | 0-6 months after index biologic prescription | No | |
Primary | Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants | 7-12 months after index biologic prescription | No | |
Secondary | Prevalence of depression and/or anxiety (ICD-9 diagnosis code) | Between 0-6 months after index biologic prescription | No | |
Secondary | Prevalence of depression and/or anxiety (ICD-9 diagnosis code) | 7-12 months after index biologic prescription | No |
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