Changes in the Use of Opioids, Antidepressants, and Benzo... | NCT01137838

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

NCT01137838

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

May 17, 2011Estimated

Enrollment

1,810Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jun 2, 2010

First Submission Date that Met QC Criteria

Jun 4, 2010

First Posted Date

Jun 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2011

Last Update Posted Date

May 17, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,810Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants		0-6 months after index biologic prescription
Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants		7-12 months after index biologic prescription

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of depression and/or anxiety (ICD-9 diagnosis code)		Between 0-6 months after index biologic prescription
Prevalence of depression and/or anxiety (ICD-9 diagnosis code)		7-12 months after index biologic prescription

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Commercial insurance claims database

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

References Module

Citations

Not provided

Label	URL
BMS Clinical Trials Disclosure	View source
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm	View source

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases