Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes

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

Clinical Phase

PHASE4

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Brief Summary

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The purpose of this study is to determine the preference of RA patients for the new Enbrel® (etanercept) pre-filled syringe in patients who are already taking Enbrel®.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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Arthritis Rheumatology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Etanercept

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have established RA diagnosis as determined by ACR criteria
* Be current user of etanercept-lyophilized preparation for at least 4 consecutive weeks of etanercept dosing on either a once weekly or twice weekly regimen
* Subject must be able to self inject
* Give written informed consent

Exclusion Criteria

* Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
* Subject of childbearing potential is pregnant (e.g., positive HCG test) or is breast-feeding
* Elective surgery is planned during study period
* Subjects allergic to latex

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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United States

Other Identifiers

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20040201

Identifier Type: -

Identifier Source: org_study_id