Etanercept (Enbrel®) in Psoriasis - Pediatrics
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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: NCT00078819 |
Recruitment Status
:
Completed
First Posted
: March 9, 2004
Last Update Posted
: July 30, 2013
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
Tracking Information | ||||
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First Submitted Date ICMJE | March 5, 2004 | |||
First Posted Date ICMJE | March 9, 2004 | |||
Last Update Posted Date | July 30, 2013 | |||
Study Start Date ICMJE | August 2004 | |||
Actual Primary Completion Date | February 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
PASI (Psoriasis Area and Severity Index) 75 response at week 12, defined as a 75% or greater decrease in PASI score (i.e., improvement) from baseline at week 12. [ Time Frame: 12 weeks ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00078819 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Etanercept (Enbrel®) in Psoriasis - Pediatrics | |||
Official Title ICMJE | Placebo-controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS) | |||
Brief Summary | This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with Psoriasis. This is a Phase 3 blinded, placebo-controlled study. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Psoriasis | |||
Intervention ICMJE |
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Study Arms |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
211 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date | June 2007 | |||
Actual Primary Completion Date | February 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE |
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Sex/Gender |
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Ages | 4 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | Canada, United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00078819 | |||
Other Study ID Numbers ICMJE | 20030211 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Amgen | |||
Study Sponsor ICMJE | Amgen | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Amgen | |||
Verification Date | July 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |