Back to resultsPreference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Arthritis, Rheumatology
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00094341
Brief Title
Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes
Official Title
An Open-Label, Randomized, Crossover Study to Assess Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Arthritis, Rheumatology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Etanercept
Primary Outcome Measure Information:
Title
The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.
Secondary Outcome Measure Information:
Title
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:
Title
Ease of use
Title
Hand discomfort during the injection
Title
Satisfaction with number of steps
Title
Time involved with the injection
Title
Nervousness with injection
Title
Confidence with the injection
Title
Convenience of use and
Title
Overall preference with the auto-injector or pre-filled syringes compared to the lyophilized preparation.
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.enbrel.com/
Description
FDA-approved Drug Labeling
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_916_ENBREL_20040201.pdf
Description
To access clinical trial results information click on this link
Learn more about this trial
Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes
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