Clinical trial NCT00078819
Conditions: Psoriasis
Keywords: Pediatric Psoriasis
Sponsor: Amgen
Start date: 2004-09-08; Completion date: 2007-06-01
Enrollment: 211 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

Detailed 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.

Arms: arm 1: Participants received placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.

Participants received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).

At week 36, participants with PASI 50 at week 24 or PASI 75 at week 36 were re-randomized to placebo or etanercept in the 12-week double-blind, withdrawal-retreatment period (weeks 37 to 48). arm 2: Participants received 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.

Participants received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).

At week 36, participants with PASI 50 at week 24 or PASI 75 at week 36 were re-randomized to placebo or etanercept in the 12-week double-blind, withdrawal-retreatment period (weeks 37 to 48).
Interventions: intervention 1: Etanercept intervention 2: Placebo
Intervention descriptions: intervention 1: Etanercept 0.8 mg/kg (up to an intended dose of 50 mg) by subcutaneous injection once a week intervention 2: Placebo matching to etanercept administered by subcutaneous injection once a week

Protocol documents: