Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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®.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
Etanercept
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