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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01137838
First Posted: June 7, 2010
Last Update Posted: May 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
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
Rheumatoid Arthritis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants [ Time Frame: 0-6 months after index biologic prescription ]
  • Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants [ Time Frame: 7-12 months after index biologic prescription ]

Secondary Outcome Measures:
  • Prevalence of depression and/or anxiety (ICD-9 diagnosis code) [ Time Frame: Between 0-6 months after index biologic prescription ]
  • Prevalence of depression and/or anxiety (ICD-9 diagnosis code) [ Time Frame: 7-12 months after index biologic prescription ]

Enrollment: 1810
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Commercial insurance claims database
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137838


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01137838     History of Changes
Other Study ID Numbers: IM101-238
First Submitted: June 2, 2010
First Posted: June 7, 2010
Last Update Posted: May 17, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antidepressive Agents
Psychotropic Drugs