Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-29 @ 2:47 PM
Study NCT ID:
NCT00585650
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet
Sponsor:
University of California, Irvine
Organization:
Study Overview
Official Title:
Double-blind, Randomized, Placebo-controlled Study of Recombinant Human Tumor Necrosis Factor Receptor (p75) Fusion Protein Etanercept (Enbrel) in Patients With Moderate to Severe Plaque Psoriasis of the Hands and/or Feet
Status:
COMPLETED
Status Verified Date:
2023-08
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 research study is to see how well (compared to placebo) Enbrel® (etanercept) 50 mg twice a week for 12 weeks affects plaque psoriasis of the hands and/or feet (palmoplantar psoriasis).
Detailed Description:
This multicenter investigation is a 12 week, double-blind, randomized trial of etanercept, 50 mg twice weekly versus placebo in subjects with palmoplantar psoriasis (PPP). Subjects who meet the eligibility criteria will be randomized to either 50 mg etanercept twice weekly or placebo. Subcutaneous injections will occur twice weekly at approximately the same time of day over the 12-week treatment period. The primary efficacy endpoint will be assessed after 12 weeks of treatment. At the end of the first 12 weeks, all patients (both treatment and placebo arms) will be treated with etanercept 50 mg twice a week (BIW) for an additional 12 weeks.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Amgen Protocol 20060514 | OTHER | Amgen 20060514 | View |