Transitioning From Cyclosporine to Alefacept in Psoriasis

Psoriasis Clinical Trial

Official title:

Investigator-Initiated, Use Study of Alefacept (Amevive) in Combination With Tapering Doses of Cyclosporine in Patients With Moderate to Severe Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143806
• Other study ID #: 4513
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2005
• Last updated: December 31, 2008
• Start date: October 2003
• Est. completion date: May 2007

Study information

• Verified date: December 2008
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Transitioning patients from cyclosporine to alefacept

Locations

Country	Name	City	State
United States	UMDNJ Clinical Research Center	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static physicians global assessment (PGA) and quality of life as measured by DLQI