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OpenTrials
Completed

NCT Number: NCT01137838

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants

    Time frame: 0-6 months after index biologic prescription

  2. Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants

    Time frame: 7-12 months after index biologic prescription

Secondary outcomes

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

    Time frame: Between 0-6 months after index biologic prescription

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

    Time frame: 7-12 months after index biologic prescription

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 7, 2010
Registry last updated
May 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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