Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-03-14 @ 6:35 AM
Study NCT ID:
NCT02274792
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2014-10-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Patients With Plaque Psoriasis
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
A Single-arm Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Subjects With Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2016-10
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:
The purpose of this study is to learn more about the immune response to etanercept produced using a modified process in patients with plaque psoriasis.
Detailed Description:
This is a multicenter, open-label, single-arm phase 4 study in patients with plaque psoriasis who are etanercept-naïve and who are not receiving methotrexate therapy. The study will consist of a screening period of up to 30 days, a 24-week treatment period and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for patients with plaque psoriasis.
Study Oversight
Has Oversight DMC:
False
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?: