Rheumatoid Arthritis
Conditions
Keywords
Arthritis, Rheumatology
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®.
Interventions
DRUGEtanercept
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ease of use | — |
| Hand discomfort during the injection | — |
| Satisfaction with number of steps | — |
| Time involved with the injection | — |
| 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 | — |
| 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 | — |
| Nervousness with injection | — |
Outcome results
None listed