Changes in the Use of Opioids, Antidepressants, and Benzodiazepines in Rheumatoid Arthritis Patients Treated With Biologic Agents

Rheumatoid Arthritis Clinical Trial

Official title:

Changes in the Use of Opioids, Antidepressants, and Benzodiazepines in Rheumatoid Arthritis Patients Treated With Biologic Agents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137838
• Other study ID #: IM101-238
• Status: Completed
• Phase: N/A
• First received: June 2, 2010
• Last updated: May 16, 2011
• Start date: October 2009
• Est. completion date: October 2010

Study information

• 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

Clinical 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

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

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form