Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00094341
First received: October 16, 2004
Last updated: December 4, 2008
Last verified: December 2008

October 16, 2004
December 4, 2008
October 2004
Not Provided
The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.
Not Provided
Complete list of historical versions of study NCT00094341 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes
An Open-Label, Randomized, Crossover Study to Assess Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes

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®.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: Etanercept
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00094341
20040201
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP