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


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Réunion

 




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

This study is no longer 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 Information


Washington
      Research Site, Renton,  Washington,  United States

More Information

AmgenTrials clinical trials website

CenterWatch Clinical Trials Listing Service

Study ID Numbers:  20040201
Record last reviewed:  November 2004
Last Updated:  November 17, 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 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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