Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078819
Status:
COMPLETED
Last Update Posted:
2019-07-29
First Post:
2004-03-05
Brief Title:
Etanercept Enbrel in Psoriasis - Pediatrics
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
Placebo-controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis PEDS
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None