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

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Etanercept (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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®.

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

Study design: Treatment, Randomized, Open Label, Crossover Assignment

Primary outcome: The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Research Site, Phoenix, Arizona, United States

Research Site, Victorville, California, United States

Research Site, Pasadena, California, United States

Research Site, Santa Cruz, California, United States

Research Site, N. Hollywood, California, United States

Research Site, Los Angeles, California, United States

Research Site, Jupiter, Florida, United States

Research Site, Pensacola, Florida, United States

Research Site, Tamarac, Florida, United States

Research Site, Boise, Idaho, United States

Research Site, Fort Wayne, Indiana, United States

Research Site, Louisville, Kentucky, United States

Research Site, Owensboro, Kentucky, United States

Research Site, Portland, Maine, United States

Research Site, Annapolis, Maryland, United States

Research Site, Rochester Hills, Michigan, United States

Research Site, Riverdale, New Jersey, United States

Research Site, Manalapan, New Jersey, United States

Research Site, Jericho, New York, United States

Research Site, Orchard Park, New York, United States

Research Site, Columbus, Ohio, United States

Research Site, Duncansville, Pennsylvania, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Wynnewood, Pennsylvania, United States

Research Site, Johnston, Rhode Island, United States

Research Site, Cordova, Tennessee, United States

Research Site, Knoxville, Tennessee, United States

Research Site, Sugar Land, Texas, United States

Research Site, Fort Worth, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Reston, Virginia, United States

Research Site, Richmond, Virginia, United States

Research Site, Edmonds, Washington, United States

Research Site, Renton, Washington, United States

Research Site, Spokane, Washington, United States

AmgenTrials clinical trials website

Starting date: October 2004
Last updated: May 30, 2008