Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis

Psoriasis Clinical Trial

Official title:

A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333034
• Other study ID #: 0881A6-318
• Status: Completed
• Phase: Phase 3
• First received: May 23, 2006
• Last updated: December 4, 2007
• Start date: June 2006
• Est. completion date: May 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: -Adults greater than or equal to 18 years of age with clinically stable plaque psoriasis involving greater than or equal to 10% of the body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening. -Failure to respond to, or have a contraindication to, or intolerant to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration: Methotrexate (MTX), Acitretin, Cyclosporine, Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and Ultraviolet A (PUVA), Fumarate Exclusion Criteria: -Previous treatment with etanercept, antibody to TNF or other TNF inhibitors. -Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline.

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
Wyeth is now a wholly owned subsidiary of Pfizer	Amgen

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the PASI 75 response at week 12. PASI 75 is defined as a 75% or greater improvement in PASI score from baseline.
Secondary	The secondary efficacy endpoints will include but not limited to: PASI 50, PASI 75 (at visit other than week 12, PASI 90, PASI score PGA of 0 or 1 (clear or minimal, Patient global assessment of psoriasis, DLQI,
Secondary	EQ5D, FACIT-F.