Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

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NCT00482170

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Study Location
Brugge, , 08000, Belgium
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Contact
1-800-718-1021
[email protected]
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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Compare 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 Auto-injector and the Etanercept Prefilled Syringe) in Patients With Psoriasis.
Brief Summary 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.
Detailed Description 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.
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 Psoriasis
Intervention  ICMJE
  • Device: Enbrel (etanercept)
    Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly
  • Device: Etanercept
    Arm 2 = Enbrel 50 mg Autoinjector twice weekly
Study Arms  ICMJE
  • 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
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: March 1, 2012)		421
Original Enrollment  ICMJE
 (submitted: June 1, 2007)		524
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 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.
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 Belgium,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Norway,   Spain,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00482170
Other Study ID Numbers  ICMJE 0881A6-3326
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 March 2012

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