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Completed

NCT Number: NCT00143806

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UMDNJ Clinical Research Center

New Brunswick, New Jersey, 08903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transitioning patients from cyclosporine to alefacept

Drug

Primary outcomes

  1. Static physicians global assessment (PGA) and quality of life as measured by DLQI

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • Biogen

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2007
First posted
Sep 2, 2005
Registry last updated
Jan 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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