Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: September 13, 2005
• First Posted Date: September 19, 2005
• Results First Submitted Date: March 31, 2009
• Results First Posted Date: May 4, 2010
• Last Update Posted Date: February 25, 2013
• Study Start Date: December 2004
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (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 (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 (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 (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: Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Psoriasis
• Intervention: Drug: Etanercept
• Study Arms: Not Provided

Publications *

• Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17.
• Griffiths CE, Luger TA, Brault Y, Germain JM, Mallbris L. Retreatment in patients with psoriasis achieving response with etanercept after relapse due to treatment interruption: results from the CRYSTEL study. J Eur Acad Dermatol Venereol. 2015 Mar;29(3):468-73. doi: 10.1111/jdv.12585. Epub 2014 Aug 4.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 7, 2010): 720
• Original Enrollment (submitted: September 13, 2005): 700
• Actual Study Completion Date: February 2007
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom

Administrative Information

• NCT Number: NCT00195507
• Other Study ID Numbers: 0881A6-101764
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

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

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: April 2010