Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00143806
Status:
COMPLETED
Last Update Posted:
2009-01-05
First Post:
2005-08-31
Brief Title:
Transitioning From Cyclosporine to Alefacept in Psoriasis
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Investigator-Initiated Use Study of Alefacept Amevive in Combination With Tapering Doses of Cyclosporine in Patients With Moderate to Severe Psoriasis
Status:
COMPLETED
Status Verified Date:
2008-12
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 devise a safe and effective method for transitioning patients from cyclosporine to alefacept
Detailed Description:
The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept Patients in the study are well controlled on cyclosporine and desire to switch to alefacept The study is done in three phases In Phase 1 12 week duration the two drugs will be overlapped with cyclosporine slowly tapering Both drugs will be discontinued after 12 weeks In Phase 2 12 weeks duration patients are off both drugs In Phase 3 24 weeks long patients are on a second course of alefacept alone for 12 weeks and then off for 12 weeks Topical and UV light treatments are allowed throughout the study Total length of study is one 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