Clinical Trial: Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (etanercept) Auto-Injector versus Enbrel® Pre-Filled Syringes


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

This study is currently recruiting patients.

Sponsored by:	Amgen
Information provided by:	Amgen

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	Treatment or Intervention	Phase
Rheumatoid Arthritis	Drug: Etanercept	Phase IV

MedlinePlus related topics: Rheumatoid Arthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Crossover Assignment

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

Further Study Details:

Study start: October 2004

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

> 18 years at the screening baseline visit
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

Location and Contact Information

Amgen Call Center 866-572-6436

Washington
Research Site, Renton, Washington, United States; Recruiting

More Information

AmgenTrials clinical trials website

CenterWatch Clinical Trials Listing Service

Study ID Numbers: 20040201
Record last reviewed: October 2004
Record first received: October 16, 2004
ClinicalTrials.gov Identifier: NCT00094341
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10

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