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Etanercept (Enbrel®) in Psoriasis - Pediatrics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00078819
First received: March 5, 2004
Last updated: July 26, 2013
Last verified: July 2013
History of Changes

March 5, 2004
July 26, 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00078819 on ClinicalTrials.gov Archive Site
  • PASI 50 response at week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • PASI 90 response at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clear or almost clear status of sPGA (Static Physician Global Assessment of psoriasis) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent improvement from baseline in CDLQI (Children's Dermatology Life Quality Index) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
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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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
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
Both
4 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada,   United States
 
NCT00078819
20030211
Not Provided
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Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2013

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