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

NCT ID: NCT01137851

Last Updated: 2010-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3940 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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New to bDMARD

New to bDMARD RA patients with high and low cost share who continue or discontinue treatment

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

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http://www.bms.com/clinical_trials/Pages/home.aspx

BMS Clinical Trials Disclosure

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Other Identifiers

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IM101-256

Identifier Type: -

Identifier Source: org_study_id