Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes
This study has been completed.
Information provided by:
First received: October 16, 2004
Last updated: December 4, 2008
Last verified: December 2008
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 Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Amgen:
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
|Study Start Date:||October 2004|
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