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Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Etanercept
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Informed consent signed by patients prior to study entry
  2. 18 years of age or older at screening visit
  3. Patients with moderate to severe psoriasis
  4. Patients who have failed conventional systemic treatment
  5. Patients who have a contraindication to conventional systemic therapy
  6. Patients who are intolerant to conventional systemic therapy
  7. A negative serum pregnancy test at screening in women of childbearing potential
  8. Able to self-inject study drug or have a designee who can do so
  9. In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment

    Secondary Outcome Measures

    Reduction and/or withdrawal of systemic therapies, Proportion of patients with plaque psoriasis achieving PASI 50, 75 and 90 at each evaluation and BSA at each evaluation

    Full Information

    First Posted
    December 21, 2007
    Last Updated
    December 26, 2007
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00581165
    Brief Title
    Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept
    Official Title
    Evaluating Safety in Patients With Moderate to Severe Psoriasis Treated With Etanercept
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluate (i) safety of etanercept in patients with moderate to severe psoriasis in Spain; (ii) the incidence of adverse events reported in these patients, and (iii) the role that age and concomitant therapy might play in the development of adverse reactions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    500 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Etanercept
    Intervention Description
    recommended dose of enbrel is 25mg administered twice weekly.
    Primary Outcome Measure Information:
    Title
    Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Reduction and/or withdrawal of systemic therapies, Proportion of patients with plaque psoriasis achieving PASI 50, 75 and 90 at each evaluation and BSA at each evaluation
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Informed consent signed by patients prior to study entry 18 years of age or older at screening visit Patients with moderate to severe psoriasis Patients who have failed conventional systemic treatment Patients who have a contraindication to conventional systemic therapy Patients who are intolerant to conventional systemic therapy A negative serum pregnancy test at screening in women of childbearing potential Able to self-inject study drug or have a designee who can do so In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept

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