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

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00094341

Purpose

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®.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Etanercept	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	215
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094341

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00094341 History of Changes
Other Study ID Numbers:	20040201
Study First Received:	October 16, 2004
Last Updated:	December 4, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Arthritis
Rheumatology

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012