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

Tracking Information

First Received Date ^ICMJE

October 16, 2004

Last Updated Date

December 4, 2008

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00094341 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-Label, Randomized, Crossover Study to Assess Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes

Brief Summary

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Crossover Assignment

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: Etanercept

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

215

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00094341

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20040201

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP