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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111449
• Other study ID #: 20030117
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2005
• Last updated: May 13, 2013
• Start date: June 2003

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Etanercept

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Wyeth is now a wholly owned subsidiary of Pfizer

References & Publications (3)

Krishnan R, Cella D, Leonardi C, Papp K, Gottlieb AB, Dunn M, Chiou CF, Patel V, Jahreis A. Effects of etanercept therapy on fatigue and symptoms of depression in subjects treated for moderate to severe plaque psoriasis for up to 96 weeks. Br J Dermatol. — View Citation

Tyring S, Gordon KB, Poulin Y, Langley RG, Gottlieb AB, Dunn M, Jahreis A. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol. 2007 Jun;143(6):719-26. — View Citation

Tyring S, Gottlieb A, Papp K, Gordon K, Leonardi C, Wang A, Lalla D, Woolley M, Jahreis A, Zitnik R, Cella D, Krishnan R. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. L — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
Secondary	Dermatology Live Quality Index (DLQI) response at week 12
Secondary	Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12
Secondary	Psoriasis pain (VAS) at week 12
Secondary	Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12
Secondary	PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy
Secondary	Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy
Secondary	Adverse events, infections injection site reactions during long-term therapy
Secondary	Serious adverse events and infections during long-term therapy
Secondary	Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling