Psoriasis
Conditions
Keywords
psoriasis, cyclosporine, transition, alefacept
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.
Interventions
DRUGTransitioning patients from cyclosporine to alefacept
Sponsors
Biogen
University of Medicine and Dentistry of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult psoriasis patients (18 to 80 years old), who are well controlled on cyclosporine (Static PGA score of mild, minimal or clear) and who need or desire to stop cyclosporine and start alefacept.
Exclusion criteria
* CD4 \<400 * Active infection (other than trivial URI, etc.) * History of AIDS or Hepatitis B, C * Inability to understand consent or comply with study requirements * Pregnancy or Lactation * History of heart or liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Static physicians global assessment (PGA) and quality of life as measured by DLQI | — |
Countries
United States
Outcome results
None listed