Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

NCT00459706

Last updated date
Study Location
Frederiksberg, , 02000, Denmark
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
Official Title  ICMJE A 3-Month, Randomised, Open-Label, Parallel-Group, Descriptive Study To Explore And Compare Perceptions and Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis
Brief Summary The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in patients with rheumatoid arthritis (RA).
Detailed Description

This study describes patient perceptions related to device attributes, which are of importance in describing overall patient perception. A range of potential device benefits (e.g. ease of use, convenience, confidence, presence or absence of fear, side effects related to administration) is captured using a questionnaire based on the outputs of patient interviews.

The study aims to characterize patient attributes that will indicate when one device may result in greater patient satisfaction than another. Patient attributes are composed of patient characteristics (e.g. age, sex, self efficacy, expectations of treatment, perception of their illness) and RA characteristics (e.g. disease severity, disease duration, prior treatment, functional impairment).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Device: Enbrel 50 mg Prefilled Syringe
    Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
  • Device: Enbrel 50 mg Autoinjector
    Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
Study Arms  ICMJE
  • Experimental: Enbrel 50 mg Prefilled Syringe
    Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
    Intervention: Device: Enbrel 50 mg Prefilled Syringe
  • Experimental: Enbrel 50 mg Autoinjector
    Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
    Intervention: Device: Enbrel 50 mg Autoinjector
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: February 20, 2013)
640
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion:

  • Diagnosis of RA according to the ACR-Criteria.
  • Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
  • Willing and able to self-inject etanercept.

Exclusion:

  • Prior experience of biologics and anti-TNF treatment for their RA including etanercept.
  • Sepsis or risk of sepsis.
  • Current or recent infections, including chronic or localized.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Finland,   France,   Germany,   Italy,   Netherlands,   Norway,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00459706
Other Study ID Numbers  ICMJE 0881K1-6000
B1801017 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date February 2013

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