Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis
NCT00195507
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Stable, active plaque psoriasis
- Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate
- 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
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Descriptive Information | ||||||||||||||||||||||||||||||||||
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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 * |
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* 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 | 720 | |||||||||||||||||||||||||||||||||
Original Enrollment ICMJE | 700 | |||||||||||||||||||||||||||||||||
Actual Study Completion Date ICMJE | February 2007 | |||||||||||||||||||||||||||||||||
Primary Completion Date | Not Provided | |||||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |