Etanercept (Enbrel®) in Psoriasis - Pediatrics

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. Identifier: NCT00078819
Recruitment Status : Completed
First Posted : March 9, 2004
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):

March 5, 2004
March 9, 2004
July 30, 2013
August 2004
February 2006   (Final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00078819 on Archive Site
  • PASI 50 response at week 12 [ Time Frame: 12 Weeks ]
  • PASI 90 response at week 12 [ Time Frame: 12 weeks ]
  • Clear or almost clear status of sPGA (Static Physician Global Assessment of psoriasis) at week 12 [ Time Frame: 12 weeks ]
  • Percent improvement from baseline in CDLQI (Children's Dermatology Life Quality Index) at week 12 [ Time Frame: 12 weeks ]
  • Safety as measured by adverse events, infections, injection site reaction, lab toxicity, vital signs, antibodies to etanercept, and disease rebound during the investigational product withdrawal period [ Time Frame: 48 weeks ]
  • Pharmacokinetics [ Time Frame: 48 weeks ]
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Etanercept (Enbrel®) in Psoriasis - Pediatrics
Placebo-controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS)

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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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: Enbrel®
    0.8 mg/kg (up to an intended dose of 50 mg) once weekly
  • Drug: Placebo
    0.8 mg/kg (up to an intended dose of 50 mg) once weekly
  • Placebo Comparator: Placebo
    100 subjects - 12 weeks
    Intervention: Drug: Placebo
  • Experimental: Enbrel
    100 subjects
    Intervention: Drug: Enbrel®

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2007
February 2006   (Final data collection date for primary outcome measure)
  • Patients with plaque psoriasis - Patient may not receive certain psoriasis medications during the study
Sexes Eligible for Study: All
4 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
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Canada,   United States
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Study Director: MD Amgen
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP