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An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-Injector in Subjects With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00346294
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : February 20, 2009
Sponsor:
Collaborator:
Immunex Corporation
Information provided by:
Amgen

Tracking Information
First Submitted Date  ICMJE June 27, 2006
First Posted Date  ICMJE June 29, 2006
Last Update Posted Date February 20, 2009
Study Start Date  ICMJE January 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2008)
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects. [ Time Frame: 22 Days ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2006)
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.
Change History Complete list of historical versions of study NCT00346294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2008)
  • To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects. [ Time Frame: 22 Days ]
  • To determine the rate of failed drug deliveries (as opposed to device failures). [ Time Frame: 22 Days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2006)
  • To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects.
  • To determine the rate of failed drug deliveries (as opposed to device failures).
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-Injector in Subjects With Rheumatoid Arthritis
Official Title  ICMJE An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-Injector in Subjects With Rheumatoid Arthritis
Brief Summary An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Other: Etanercept
Intervention type was to study the drug delivery method.
Study Arms Single-Arm
Open-lable Single Arm Study
Intervention: Other: Etanercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2006)
115
Original Enrollment  ICMJE Same as current
Actual Study Completion Date July 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: - Diagnosis of rheumatoid arthritis

  • RA subjects
  • 18 years or older
  • Currently taking etanercept in pre-filled syringes for at least 4 weeks
  • Subjects must give written informed consent
  • Subjects must be able to read and write in English Exclusion Criteria: - Subject is not using adequate contraception
  • Subject is pregnant or breast feeding
  • Significant concurrent medical diseases
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00346294
Other Study ID Numbers  ICMJE 20050207
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Global Development Leader, Amgen Inc.
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Immunex Corporation
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date February 2009

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