Rheumatoid Arthritis (DMARD) Intervention and UtilizationStudy

NCT ID: NCT00116714

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

4968 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-10-31

Study Completion Date

2008-10-31

Brief Summary

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The Rheumatoid Arthritis DMARD Intervention and Utilization Study (RADIUS 1) is designed to systematically collect and document use patterns, effectiveness, and safety of DMARD treatments currently used in the management of rheumatoid arthritis (RA). It is anticipated that study data may help improve the quality of information upon which clinical decisions are based.

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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Observation

DMARD

Intervention Type DRUG

All subjects were required to initiate, add or change DMARD therapy at study entry.

Interventions

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DMARD

All subjects were required to initiate, add or change DMARD therapy at study entry.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Fulfillment of the 1987 American Rheumatism Association criteria for RA
* Currently requiring a new DMARD (change or addition)

Exclusion Criteria

* Currently enrolled in a clinical trial with treatments or patient visits imposed by a protocol
* Nursing or pregnant women
* Patients with active infection
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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016.0034

Identifier Type: -

Identifier Source: secondary_id

20021634

Identifier Type: -

Identifier Source: org_study_id

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