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

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ClinicalTrials.gov Identifier: NCT01137838
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

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
Rheumatoid Arthritis

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 : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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

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

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01137838     History of Changes
Other Study ID Numbers: IM101-238
First Posted: June 7, 2010    Key Record Dates
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