Effect of Patient Cost Sharing on Treatment Discontinuati... | NCT01137851

Studies
Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients

NCT01137851

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Oct 1, 2010Estimated

Enrollment

3,940Actual

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

Sep 2010

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

Nov 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jun 3, 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

Sep 30, 2010

Last Update Posted Date

Oct 1, 2010Estimated

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

The purpose of this study is to assess the impact of patient cost sharing on treatment discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA)

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

3,940Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
New to bDMARD		New to bDMARD RA patients with high and low cost share who continue or discontinue treatment

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of patient cost share on discontinuation		Assessed from first prescription date and followed for 1-year

Secondary Outcomes

Measure	Description	Time Frame
RA-related healthcare utilization and costs		Pre-index: 6-month period prior to the index drug date
All-cause healthcare utilization and costs		Pre-index: 6-month period prior to the index drug date

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Patients diagnosed with Rheumatoid Arthritis (RA) who newly initiated a biologic DMARD (bDMARD) during a study timeframe of 1/01/06 to 3/31/09.

Inclusion Criteria:

18 to 64 years of age at index date
Diagnosis of RA during the study period (ICD-9CM 714.xx)
Evidence of at least one biologic DMARD of interest during the study timeframe
Continuous enrollment during the study timeframe
Both medical and pharmacy benefits
No evidence of a claim for a bDMARD in the 6-month pre-period

Exclusion Criteria:

Patients are excluded if they have a diagnosis of psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis at any time during the study timeframe; have a claim for Rituxan, IV etanercept, or IV adalimumab; or have Medicare or Medicaid during the study timeframe

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Commercial health plan members

Sampling Method

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