Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00245960

First received: October 26, 2005

Last updated: March 31, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 26, 2005

Last Updated Date

March 31, 2009

Start Date ^ICMJE

December 2005

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy of Two Different Treatment Regimens of Etanercept in Treating Skin Manifestations of Psoriasis Subjects With Psoriatic Arthritis. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To compare the efficacy of the two different treatment regimens of etanercept in treating the skin manifestations of psoriasis subjects with psoriatic arthritis over 12 weeks.

Change History

Complete list of historical versions of study NCT00245960 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy of Two Different Treatment Regimens of Etanercept in Treating Joint Disease. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Compare the efficacy of two different treatment regimens of etanercept in treating the skin manifestations over 24 weeks and joint disease over 12 and 24 weeks.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

Official Title ^ICMJE

A Randomized, Double-Blind, Two-Period Study to Evaluate the Safety and Efficacy of Etanercept on Skin and Joint Disease in Psoriasis Subjects With Psoriatic Arthritis.

Brief Summary

To assess the efficacy of two different treatment regimens of etanercept in psoriasis subjects with psoriatic arthritis with respect to both the skin and joint manifestations.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Psoriatic Arthritis

Intervention ^ICMJE

Drug: etanercept

Group A: Period 1: 50mg BIW. Period 2: 50 mg QW. Group B: Period 1 and 2: 50mg QW.

Study Arm (s)

Active Comparator: A
Intervention: Drug: etanercept
Active Comparator: B
Intervention: Drug: etanercept

Publications *

* 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

752

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 years of age or older at time of consent
Active Psoriatic Arthritis
Clinically stable, plaque psoriasis involving more than 10% of the body surface area

Exclusion Criteria:

Evidence of skin conditions other than psoriasis that would interfere with skin examinations.
Systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation
Prior exposure to any TNF-inhibitor, including etanercept

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, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Saudi Arabia, Serbia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00245960

Other Study ID Numbers ^ICMJE

0881A5-401

Has Data Monitoring Committee

Not Provided

Responsible Party

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

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Trial Manager	For Argentina, scheima@wyeth.com or rendop@wyeth.com
Principal Investigator:	Trial Manager	For Belgium, trials-BEL@wyeth.com
Principal Investigator:	Trial Manager	For Denmark, Finland, Sweden, MedInfoNord@wyeth.com
Principal Investigator:	Trial Manager	For Germany, medinfoDEU@wyeth.com
Principal Investigator:	Trial Manager	For Greece, decresg@wyeth.com
Principal Investigator:	Trial Manger	For Hungary, WPBUMED@wyeth.com
Principal Investigator:	Trial Manager	For Australia, Korea, Taiwan, medinfo@wyeth.com
Principal Investigator:	Trial Manager	For Mexico, gomezlj@wyeth.com
Principal Investigator:	Trial Manager	For Netherlands, trials-NL@wyeth.com
Principal Investigator:	Trial Manager	For Poland, WPWZMED@wyeth.com
Principal Investigator:	Trial manager	For Switzerland, med@wyeth.com
Principal Investigator:	Trial Manager	For Turkey, Erisc@wyeth.com
Principal Investigator:	Trial Manager	For UK, ukmedinfo@wyeth.comÂ
Principal Investigator:	Trial Manager	For Austria, WPVIMED@wyeth.com
Principal Investigator:	Trial Manager	For Portugal,Saudi Arabia, clintrialparticipation@wyeth.com
Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:	Trial Manager	For France, infomedfrance@wyeth.com
Principal Investigator:	Trial Manager	For Italy, descresg@wyeth.com
Principal Investigator:	Trial Manager	For Spain, infomed@wyeth.com

Information Provided By

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

March 2009

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

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