Etanercept (Enbrel®) in Psoriasis - Pediatrics

Condition(s) targeted: Psoriasis

Intervention: Enbrel® (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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

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

Official title: Placebo-Controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

PASI 50 response at week 12

PASI 90 response at week 12

Clear or almost clear status of sPGA (Static Physician Global Assessment of psoriasis) at week 12

Percent improvement from baseline in CDLQI (Children's Dermatology Life Quality Index) at week 12

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

Pharmacokinetics

Minimum age: 4 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

- Patients with plaque psoriasis - Patient may not receive certain psoriasis medications

during the study

AmgenTrials clinical trials website

Starting date: August 2004
Ending date: June 2007
Last updated: March 6, 2008