Rheumatoid Arthritis DMARD Intervention and UtilizationStudy

NCT ID: NCT00116727

Last Updated: 2011-05-06

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

5103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-10-31

Study Completion Date

2008-10-31

Brief Summary

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To systematically collect and document use patterns, effectiveness and safety of DMARD treatments currently used in the management of rheumatoid arthritis. The primary purpose of this study is to estimate the incidence of serious adverse experiences and adverse experiences of interest in patients with rheumatoid arthritis (RA) treated with ENBREL®.

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

PROSPECTIVE

Study Groups

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Drug

etanercept 50 mg/wk SC

ENBREL®

Intervention Type DRUG

50 mg/wk SC

Interventions

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ENBREL®

50 mg/wk SC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Fulfillment of the 1987 American Rheumatism Association criteria for RA
* Currently requiring the addition of ENBREL® therapy (to be taken alone or in addition to their current DMARD therapy)

Exclusion Criteria

* Currently or previously enrolled in RADIUS 1
* Currently enrolled in a clinical trial where treatments or patient visits are imposed by a protocol
* Active infections
* Known allergy to ENBREL® or any of its components
* Current treatment with ENBREL®
* Patients who have previously been demonstrated to be intolerant of or refractory to ENBREL® therapy
* Nursing or pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immunex Corporation

INDUSTRY

Sponsor Role collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

References

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Gibofsky A, Palmer WR, Keystone EC, Schiff MH, Feng J, McCroskery P, Baumgartner SW, Markenson JA. Rheumatoid arthritis disease-modifying antirheumatic drug intervention and utilization study: safety and etanercept utilization analyses from the RADIUS 1 and RADIUS 2 registries. J Rheumatol. 2011 Jan;38(1):21-8. doi: 10.3899/jrheum.100347. Epub 2010 Oct 15.

Reference Type DERIVED
PMID: 20952478 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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016.0035

Identifier Type: -

Identifier Source: secondary_id

20021635

Identifier Type: -

Identifier Source: org_study_id

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