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Completed

NCT Number: NCT00581165

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

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.

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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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

etanercept

Drug

recommended dose of enbrel is 25mg administered twice weekly.

Primary outcomes

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

    Time frame: 18 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Evaluating Safety in Patients With Moderate to Severe Psoriasis Treated With Etanercept

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 27, 2007
Registry last updated
Dec 27, 2007

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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