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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01137851
• Lead Sponsor: Bristol-Myers Squibb

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-30
• Last Update Posted: 2010-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3940

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of patient cost share on discontinuation	Assessed from first prescription date and followed for 1-year

Secondary Outcome Measures

Name	Time	Method
RA-related healthcare utilization and costs	Post-period: Index date+365 days
All-cause healthcare utilization and costs	Post-period: Index date+365 days