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):

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Enbrel® Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : August 2004
Actual Primary Completion Date : February 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. PASI 50 response at week 12 [ Time Frame: 12 Weeks ]
  2. PASI 90 response at week 12 [ Time Frame: 12 weeks ]
  3. Clear or almost clear status of sPGA (Static Physician Global Assessment of psoriasis) at week 12 [ Time Frame: 12 weeks ]
  4. Percent improvement from baseline in CDLQI (Children's Dermatology Life Quality Index) at week 12 [ Time Frame: 12 weeks ]
  5. 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 ]
  6. Pharmacokinetics [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Patients with plaque psoriasis - Patient may not receive certain psoriasis medications during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00078819

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Publications of Results:

Responsible Party: Amgen Identifier: NCT00078819     History of Changes
Other Study ID Numbers: 20030211
First Posted: March 9, 2004    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

Keywords provided by Amgen:
Pediatric Psoriasis

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors