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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01137838
Collaborator
(none)
1,810
Enrollment
12
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1810 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Changes in the Use of Opioids, Antidepressants, and Benzodiazepines in Rheumatoid Arthritis Patients Treated With Biologic Agents
    Study Start Date :
    Oct 1, 2009
    Actual Primary Completion Date :
    Oct 1, 2010
    Actual Study Completion Date :
    Oct 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants [0-6 months after index biologic prescription]

    2. Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants [7-12 months after index biologic prescription]

    Secondary Outcome Measures

    1. Prevalence of depression and/or anxiety (ICD-9 diagnosis code) [Between 0-6 months after index biologic prescription]

    2. Prevalence of depression and/or anxiety (ICD-9 diagnosis code) [7-12 months after index biologic prescription]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01137838
    Other Study ID Numbers:
    • IM101-238
    First Posted:
    Jun 7, 2010
    Last Update Posted:
    May 17, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of May 17, 2011