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Completed

NCT Number: NCT00111449

Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis

The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.

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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

- Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis

Treatment and study plan

etanercept

Drug

Primary outcomes

  1. Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.

Secondary outcomes

  1. Dermatology Live Quality Index (DLQI) response at week 12

  2. Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12

  3. Psoriasis pain (VAS) at week 12

  4. Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12

  5. PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy

  6. Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy

  7. Adverse events, infections injection site reactions during long-term therapy

  8. Serious adverse events and infections during long-term therapy

  9. Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis

Important dates

Study start
2003
First posted
May 23, 2005
Registry last updated
May 15, 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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