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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136694
• Other study ID #: IM101-230
• Status: Completed
• Phase: N/A
• First received: June 2, 2010
• Last updated: February 9, 2012
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Time Perspective: Prospective with some retrospective analysis of claims data

Recruitment information / eligibility

• Status: Completed
• Enrollment: 695
• Est. completion date: December 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No

External Links

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