Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00161655

First received: September 8, 2005

Last updated: September 25, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

September 25, 2009

Start Date ^ICMJE

April 2005

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00161655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75
and 90. Time to clear or almost clear on PGA.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

Official Title ^ICMJE

A Multicenter, Open-label, Randomized, Pilot-study to Evaluate the Efficacy and Safety of the Combination of Etanercept (ETN) and Methotrexate and of Etanercept (ETN) Alone in Patients With Plaque Psoriasis Despite Methotrexate Therapy

Brief Summary

The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in plaque psoriasis patients, treated with the combination etanercept and methotrexate compared to etanercept alone.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Psoriasis
Arthritis, Psoriatic

Intervention ^ICMJE

Drug: Etanercept
Drug: Methotrexate

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Active plaque psoriasis involving >10% body surface area and/or minimal screening PASI score 8.
Methotrexate >7.5 mg/week for the last 3 months

Exclusion Criteria:

Predominantly guttate, erythrodermic or pustular psoriasis
Other skin conditions than psoriasis

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

Denmark, Finland, Norway, Sweden

Administrative Information

NCT Number ^ICMJE

NCT00161655

Other Study ID Numbers ^ICMJE

0881A-101696

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

Information Provided By

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

September 2009

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

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