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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:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01137838
First received: June 2, 2010
Last updated: May 16, 2011
Last verified: May 2011
  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 ] [ Designated as safety issue: No ]
  • Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants [ Time Frame: 7-12 months after index biologic prescription ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of depression and/or anxiety (ICD-9 diagnosis code) [ Time Frame: Between 0-6 months after index biologic prescription ] [ Designated as safety issue: No ]
  • Prevalence of depression and/or anxiety (ICD-9 diagnosis code) [ Time Frame: 7-12 months after index biologic prescription ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137838

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

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01137838     History of Changes
Other Study ID Numbers: IM101-238
Study First Received: June 2, 2010
Last Updated: May 16, 2011
Health Authority: United States: No Health Authority

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014