Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis - Tabular View

Tracking Information

First Received Date ^ICMJE

April 17, 2008

Last Updated Date

September 30, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in PASI Scores from at Week 24. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00663052 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effect of Etanercept on the QoL of each Treatment Group. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

Official Title ^ICMJE

A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe Psoriasis

Brief Summary

The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Plaque Psoriasis
Psoriasis

Intervention ^ICMJE

Drug: Etanercept

Study Arms / Comparison Groups

Experimental: A
Experimental: B

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

250

Estimated Completion Date

October 2009

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria

18 years of age or older at time of consent.
Active, moderate to severe chronic plaque psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving greater than or equal to 10% body surface area (BSA) or PASI greater than or equal to 10.
In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine and psoralen plus ultraviolet A radiation (PUVA) therapy.

Exclusion Criteria

Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
Rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
Active or recent (within 2 years) tuberculosis (TB) infection.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina, Austria, Belgium, Czech Republic, Germany, Greece, Hungary, Italy, Korea, Republic of, Mexico, Spain, Taiwan, Thailand

Administrative Information

NCT ID ^ICMJE

NCT00663052

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth

Study ID Numbers ^ICMJE

0881A6-4425

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP