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
  Purpose

This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with Psoriasis.

This is a Phase 3 blinded, placebo-controlled study.


Condition Intervention Phase
Psoriasis
Drug: Enbrel®
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 211
Study Start Date: August 2004
Study Completion Date: June 2007
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
100 subjects - 12 weeks
Drug: Placebo
0.8 mg/kg (up to an intended dose of 50 mg) once weekly
Experimental: Enbrel
100 subjects
Drug: Enbrel®
0.8 mg/kg (up to an intended dose of 50 mg) once weekly

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Patients with plaque psoriasis - Patient may not receive certain psoriasis medications during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00078819

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00078819     History of Changes
Other Study ID Numbers: 20030211
Study First Received: March 5, 2004
Last Updated: July 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Pediatric Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014