Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis - Full Text View

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear).

Secondary Outcome Measures:

Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.
Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear" [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included.
Number of Patients With Survey Response of "Somewhat Satisfied" or Better [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied.

Enrollment:	720
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 is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
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

ClinicalTrials.gov Identifier:	NCT00195507 History of Changes
Other Study ID Numbers:	0881A6-101764
Study First Received:	September 13, 2005
Results First Received:	March 31, 2009
Last Updated:	April 7, 2010
Health Authority:	European Union: European Medicines Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Psoriasis

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012