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Completed

NCT Number: NCT00111436

Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.

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Key information

Conditions

Psoriasis Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type 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 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol)

Exclusion criteria

  • Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
  • Pregnant or breast-feeding females
  • Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis

Treatment and study plan

etanercept

Drug

Enbrel 50 mg once weekly or 50 mg twice weekly

Primary outcomes

  1. Subject incidence of adverse events, including infectious episodes

    Time frame: 72 weeks

  2. Changes from baseline in laboratory values

    Time frame: 72 weeks

Secondary outcomes

  1. Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study

    Time frame: 72 weeks

  2. Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis

    Time frame: 72 weeks

  3. Patient Global Assessment of psoriasis

    Time frame: 72 weeks

  4. Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores

    Time frame: 72 weeks

  5. Changes from baseline in SF-36 Health Survey scores

    Time frame: 72 weeks

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • Immunex Corporation
  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
May 23, 2005
Registry last updated
Apr 26, 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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