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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Frederiksberg, , 02000 Denmark
Contact
1-800-718-1021
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
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00459706
Pfizer
Completed
Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

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

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).

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
640
September 2009
April 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Finland,   France,   Germany,   Italy,   Netherlands,   Norway,   Sweden,   United Kingdom
 
 
NCT00459706
0881K1-6000
B1801017 ( Other Identifier: Pfizer )
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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