Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150982
Status:
COMPLETED
Last Update Posted:
2008-08-07
First Post:
2005-09-06
Brief Title:
Alefacept Mechanism of Action in Psoriasis
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
In Vivo Induction of T Cell Apoptosis by Alefacept LFA-3IgG1 Fusion Protein Amevive in Patients With Psoriasis An Investigator-Initiated Open-Label Mechanism of Action Study
Status:
COMPLETED
Status Verified Date:
2008-08
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:
To determine the mechanism of action of alefacept in patients with psoriasis
Detailed Description:
The purpose of the study is to better understand the mechanism of action of an FDA approved drug alefacept Subjects enrolled will be given alefacept 75 mg intravenously on a weekly basis for 12 weeks Response is assessed by improvement in the PASI score The responders will get no further treatment and the nonresponders will receive additional 4 weeks of therapy Skin biopsies will be obtained throughout the study and T-cell apoptosis will be correlated to clinical response There is no placebo group The duration of the study is approximately 1 year
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