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Completed

NCT Number: NCT00195507

Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Feldkirch, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable, active plaque psoriasis
  • Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate

Exclusion criteria

  • Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study
  • Systemic psoriasis therapy within 28 days prior

Treatment and study plan

etanercept

Drug

Primary outcomes

  1. Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks

    Time frame: 54 weeks

    Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).

Secondary outcomes

  1. Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline

    Time frame: 54 weeks

    Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.

  2. Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"

    Time frame: 54 weeks

    Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included.

  3. Number of Patients With Survey Response of "Somewhat Satisfied" or Better

    Time frame: 54 weeks

    Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis

Important dates

Study start
2004
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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