Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00195507
Previous Study | Return to List | Next Study

Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00195507
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : May 4, 2010
Last Update Posted : February 25, 2013
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 19, 2005
Results First Submitted Date  ICMJE March 31, 2009
Results First Posted Date  ICMJE May 4, 2010
Last Update Posted Date February 25, 2013
Study Start Date  ICMJE December 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks [ Time Frame: 54 weeks ]
Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Compare the efficacy of continuous versus intermittent etanercept treatment regimens over 54 weeks in subjects with psoriasis
Change History Complete list of historical versions of study NCT00195507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2010)
  • Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline [ Time Frame: 54 weeks ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Compare the effectiveness of two etanercept (ETN) treatment regimens as measure 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis
Official Title  ICMJE A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis
Brief Summary This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Drug: Etanercept
Study Arms  ICMJE Not Provided
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
Actual Enrollment  ICMJE
 (submitted: April 7, 2010)
720
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
700
Actual Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Norway,   Poland,   Portugal,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195507
Other Study ID Numbers  ICMJE 0881A6-101764
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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
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
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2010

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