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Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

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NCT00482170

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Brugge, , 08000 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
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

- Treatment of adults with moderate to severe plaque psoriasis who failed to respond to,
or who have a contraindication to, or are intolerant to other systemic therapy
including cyclosporine, methotrexate or PUVA

- Eligible for treatment with etanercept according to Summary of Product Characteristics
(SmPC), and applicable local guidelines.

- Aged 18 years or more

- Willing and able to self-inject etanercept.

- Able to store test drug at 2-8oC.

- Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week
0) for all women of childbearing potential. Sexually active women of childbearing
potential must use a medically acceptable form of contraception. Medically acceptable
forms of contraception include oral contraceptives, injectable or implantable methods,
intrauterine devices, or properly used barrier contraception. Sexually active men must
agree to use a reliable form of contraception during the study.

- Capable of understanding and willing to provide signed and dated written voluntary
informed consent before any protocol-specific procedures are performed.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior experience of biologics and anti-TNF treatment for their Psoriasis including
etanercept.

- Sepsis or risk of sepsis.

- Current or recent infections, including chronic or localized.

- Latex sensitivity.

- Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination
during the course of the study.

NCT00482170
Pfizer
Completed
Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

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Compare 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 Auto-injector and the Etanercept Prefilled Syringe) in Patients With Psoriasis.
Primary objective of this study is to compare patient satisfaction with the prefilled syringe (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary evaluation focus on the identification of patient and device attributes associated with patient satisfaction.
For the measures of patient's satisfaction with and perceptions of, their device, standard Likert scales are used. This allows the magnitude of individual's perceptions and satisfaction to be measured on a multipoint scale anchored at each end. In addition, the study will describe 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, injection site pain, injection anxiety, injection confidence) will be captured using a questionnaire. 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, demographics, social and educational status psychological status, willingness to self-manage, injection experience) and Psoriasis characteristics (e.g. disease severity, disease duration, co morbidities, prior treatment, quality of life). The study will also take the opportunity to measure health outcome measures as there may be important differences in cost of training and patient support between the two devices.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Psoriasis
  • Device: Enbrel (etanercept)
    Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly
  • Device: Etanercept
    Arm 2 = Enbrel 50 mg Autoinjector twice weekly
  • Experimental: 1
    Arm 1: Enbrel 50 mg Prefilled Syringe
    Intervention: Device: Enbrel (etanercept)
  • Active Comparator: 2
    Arm 2 Enbrel 50 mg Autoinjector
    Intervention: Device: Etanercept
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
421
September 2009
April 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA
  • Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
  • Aged 18 years or more
  • Willing and able to self-inject etanercept.
  • Able to store test drug at 2-8oC.
  • Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week 0) for all women of childbearing potential. Sexually active women of childbearing potential must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a reliable form of contraception during the study.
  • Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed.

Exclusion Criteria:

  • Prior experience of biologics and anti-TNF treatment for their Psoriasis including etanercept.
  • Sepsis or risk of sepsis.
  • Current or recent infections, including chronic or localized.
  • Latex sensitivity.
  • Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Norway,   Spain,   Sweden
 
 
NCT00482170
0881A6-3326
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
March 2012

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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1-800-718-1021

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[email protected]



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