Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept
NCT00992394
ABOUT THIS STUDY
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- Eighteen (18) years of age or older at the time of consent.
- Previously treated with etanercept for chronic plaque psoriasis for at least 12 weeks prior to the screening visit and received a total weekly dose of 50 mg per week for at least the 6 weeks preceding the day of the screening visit
- Having shown clinical response with a PGA inferior or equal to 1 at the screening visit.
- PGA inferior or equal to 1 at the baseline visit.
- Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere
with evaluations of the effect of study medication on psoriasis.
- Evidence of active or previously known medical history of inflammatory arthritis (eg,
rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis).
- Any biologics other than etanercept within the 20 weeks prior to the screening visit.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept | |||
Official Title ICMJE | Randomized Open-label Study Comparing 2 Different Strategies For Management Of Subjects With Plaque Psoriasis Who Have Responded To Etanercept Treatment | |||
Brief Summary | This study proposes to compare 2 different methods for managing a subject with psoriasis who has achieved good disease control, as defined by a clinical response with a Physician Global Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment. The first method involves stopping etanercept treatment on entry into the study, with the option to reinitiate etanercept at 50 mg once weekly after medical review and agreement between the subject and the investigator. The second method involves continuing on etanercept at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical review and agreement between the subject and the investigator. Subjects will be randomized into one of these two study arms. | |||
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 |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* 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 | 174 | |||
Original Estimated Enrollment ICMJE | 298 | |||
Actual Study Completion Date ICMJE | April 2013 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
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 | France, Germany, Greece, Hungary, Italy, Spain, Turkey, United Arab Emirates, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00992394 | |||
Other Study ID Numbers ICMJE | 0881X1-4535 B1801021 ( Other Identifier: Alias Study Number ) 2008-004439-39 ( EudraCT Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |