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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014