Etanercept (Enbrel®) in Psoriasis - Pediatrics

Psoriasis Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

On enrollment, participants underwent randomization in a 1:1 ratio to receive placebo or etanercept during the initial double-blind period. Participants could enter an escape group and receive open-label etanercept until week 12 if, at or after week 4, their Psoriasis Area and Severity Index (PASI) score either increased by more than 50% over baseline and by a minimum of 4 points at one visit or increased by more than 25% and by a minimum of 4 points at each of two consecutive visits.

During the open-label treatment period, all patients (including those who entered the escape group) received open-label etanercept. Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 could discontinue the study or add topical standard-of-care therapy (low-to-moderate-potency topical corticosteroids) and continue to receive open-label etanercept until week 48.

At week 36, participants with PASI 50 at week 24 or PASI 75 at week 36 were randomly assigned to placebo or etanercept for 12 weeks in the withdrawal period. Participants in whom PASI 75 was lost resumed open-label etanercept through week 48 in the re-treatment period. ;

Related Conditions & MeSH terms

• Psoriasis

• NCT number: NCT00078819
• Study type: Interventional
• Source: Amgen
• Status: Completed
• Phase: Phase 3
• Start date: September 8, 2004
• Completion date: June 1, 2007