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

NCT01137838 | Completed

• 1 other identifier: IM101-238
• Study Type: observational
• Target: 1,810
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants

  0-6 months after index biologic prescription

• Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants

  7-12 months after index biologic prescription

Secondary Outcomes (2)

• Prevalence of depression and/or anxiety (ICD-9 diagnosis code)

  Between 0-6 months after index biologic prescription

• Prevalence of depression and/or anxiety (ICD-9 diagnosis code)

  7-12 months after index biologic prescription

Study Arms (4)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Commercial insurance claims database

You may qualify if:

• 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

You may not qualify if:

• Prescription claims for another biologic during the observation period (including rituximab and anakinra)
• Prescriptions not continuous for at least 6 months

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 7, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 17, 2011

Record last verified: 2011-05