Transitioning From Cyclosporine to Alefacept in Psoriasis

University of Medicine and Dentistry of New Jersey

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Transitioning patients from cyclosporine to alefacept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00143806

4513

Details and patient eligibility

About

The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)