Trial record 1 of 1 for:
NCT00195507
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:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
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 |
Compare the efficacy of continuous versus intermittent etanercept treatment regimens over 54 weeks in subjects with psoriasis | |||||||||||||||||||||||||||||||||
Change History | ||||||||||||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
|
|||||||||||||||||||||||||||||||||
Original Secondary Outcome Measures ICMJE |
|
|||||||||||||||||||||||||||||||||
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 |
720 | |||||||||||||||||||||||||||||||||
Original Enrollment ICMJE |
700 | |||||||||||||||||||||||||||||||||
Actual Study Completion Date ICMJE | February 2007 | |||||||||||||||||||||||||||||||||
Primary Completion Date | Not Provided | |||||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||||||||||||||||||||||||||
Sex/Gender ICMJE |
|
|||||||||||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||||||||||
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 |