Economic Burden in Adult Patients Diagnosed With Rheumatoid Arthritis (RA) Receiving Treatment With Biologic Disease-modifying Antirheumatic Drugs (bDMARDs)

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01136694
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to explore the differences in productivity loss and costs between patients being treated for rheumatoid arthritis (RA) with biologic disease-modifying antirheumatic drugs (bDMARDs) compared to patients treated with conventional DMARDs.

Detailed Description

Time Perspective: Prospective with some retrospective analysis of claims data

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Primary Completion: 2011-04
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-09
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 695

Inclusion Criteria

• Evidence of a bDMARD or DMARD during the identification period (01 February 2009 - 31 July 2009)
• 18 years of age or older at the index year
• At least 12 months of continuous enrollment in a large commercial US health plan affiliated with i3 Innovus, including the at least 6 months and up to 12 months prior the index date (i.e., the pre-index period) and at least 6 months following the index date (i.e., the post-index (follow-up) period)
• Diagnosis of RA (reported on baseline survey)

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Exclusion Criteria

• Diagnosis of psoriasis, plaque psoriasis, or psoriatic arthritis (ICD-9 code 696.0x, or 696.1x), ankylosing spondylitis (720.0x), Crohn's disease (555.x), non-Hodgkins lymphoma (200.xx, 202.0x-202.2x, 202.7x-202.8x), or ulcerative colitis (556.x) in any position at any time during the 18-month identification period

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-reported productivity loss using the Work Limitations Questionnaire (WLQ)	At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD)

Secondary Outcome Measures

Name	Time	Method
Direct and Indirect costs associated with lost productivity (as measured by WLQ)	At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD)
Healthcare utilization and costs (total and RA-related)	At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD)
Functionality (as measured by HAQ-DI)	At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD)
RA severity (as measured by RAPID3)	At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD)
Patient reported quality of life	At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD)
Patient reported treatment satisfaction	At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD)