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

NCT ID: NCT01136694

Last Updated: 2012-02-10

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

695 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Time Perspective: Prospective with some retrospective analysis of claims data

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RA patients who are new bDMARD users

No interventions assigned to this group

RA patients who are existing DMARD users

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 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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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

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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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IM101-230

Identifier Type: -

Identifier Source: org_study_id

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