Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

This study has been completed.

First Received: September 13, 2005 Last Updated: May 31, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195507

Purpose

This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.

Condition	Intervention	Phase
Psoriasis	Drug: Etanercept	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Compare the efficacy of continuous versus intermittent etanercept treatment regimens over 54 weeks in subjects with psoriasis

Secondary Outcome Measures:

Compare the effectiveness of two etanercept (ETN) treatment regimens as measured by patient reported outcomes.
Compare the time course of initial treatment response of the two ETN treatment regimens.
Evaluate the safety and tolerability profile of the two ETN treatment regimens.

Estimated Enrollment:	700
Study Start Date:	December 2004
Study Completion Date:	February 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stable, active plaque psoriasis
Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate

Exclusion Criteria:

Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study
Systemic psoriasis therapy within 28 days prior

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195507

Show 127 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Italy,Greece, decresg@wyeth.com
Principal Investigator:	Trial Manager	For Denmark, Finland, Sweden, Norway, MedInfoNord@wyeth.com
Principal Investigator:	TRial manager	For Belgium, trials-BEL@wyeth.com
Principal Investigator:	Trial Manager	For Austria, WPVIMED@wyeth.com
Principal Investigator:	Trial Manager	For Netherlands, trials-NL@wyeth.com
Principal Investigator:	Trial Manager	For Hungary, WPBUMED@wyeth.com
Principal Investigator:	Trial Manager	For Turkey, Erisc@wyeth.com
Principal Investigator:	Trial Manager	For Poland, WPWZMED@wyeth.com
Principal Investigator:	Trial Manager	For Germany, MedinfoDEU@wyeth.com
Principal Investigator:	Trial Manager	For UK, ukmedonfo@wyeth.com

More Information

No publications provided

Study ID Numbers:	0881A6-101764
Study First Received:	September 13, 2005
Last Updated:	May 31, 2007
ClinicalTrials.gov Identifier:	NCT00195507 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by Wyeth:

Psoriasis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions
Psoriasis

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on February 09, 2010