Transitioning From Cyclosporine to Alefacept in Psoriasis
The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept.
Drug: Transitioning patients from cyclosporine to alefacept
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Investigator-Initiated, Use Study of Alefacept (Amevive) in Combination With Tapering Doses of Cyclosporine in Patients With Moderate to Severe Psoriasis|
- Static physicians global assessment (PGA) and quality of life as measured by DLQI
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||May 2007|
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.
|United States, New Jersey|
|UMDNJ Clinical Research Center|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Alice Gottlieb, MD, PhD||University of Medicine and Dentistry New Jersey|