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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094341
• Other study ID #: 20040201
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2004
• Last updated: December 4, 2008
• Start date: October 2004

Study information

• Verified date: December 2008
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Etanercept

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.
Secondary	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:
Secondary	Ease of use
Secondary	Hand discomfort during the injection
Secondary	Satisfaction with number of steps
Secondary	Time involved with the injection
Secondary	Nervousness with injection
Secondary	Confidence with the injection
Secondary	Convenience of use and
Secondary	Overall preference with the auto-injector or pre-filled syringes compared to the lyophilized preparation.
Secondary	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

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling