Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes
Phase 4
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00094341
- Lead Sponsor
- Amgen
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 215
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.
- Secondary Outcome Measures
Name Time Method Ease of use Convenience of use and 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: Confidence with the injection Hand discomfort during the injection Time involved with the injection 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 Satisfaction with number of steps Nervousness with injection