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

Amgen215 enrolled

Overview

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®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

215

Conditions

Rheumatoid Arthritis

Interventions

EtanerceptDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.

Secondary Outcomes

The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe as well as to the lyophilized preparation in the following categories:

Ease of use

Hand discomfort during the injection

Satisfaction with number of steps

Time involved with the injection

Nervousness with injection

Confidence with the injection

Convenience of use and

Overall preference with the auto-injector or pre-filled syringes compared to the lyophilized preparation.

To characterize the ability of patients to properly use by themselves either device independently and identify any sections of the instructions that were not clear, that may have led to loss of sterility to incomplete dosing

Data from ClinicalTrials.gov

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