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Transitioning From Cyclosporine to Alefacept in Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00143806
First Posted: September 2, 2005
Last Update Posted: January 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biogen
Information provided by:
Rutgers, The State University of New Jersey
  Purpose
The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept.

Condition Intervention Phase
Psoriasis Drug: Transitioning patients from cyclosporine to alefacept Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Static physicians global assessment (PGA) and quality of life as measured by DLQI

Estimated Enrollment: 13
Study Start Date: October 2003
Estimated Study Completion Date: May 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143806


Locations
United States, New Jersey
UMDNJ Clinical Research Center
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Biogen
Investigators
Principal Investigator: Alice Gottlieb, MD, PhD Rutgers, The State University of New Jersey
  More Information

ClinicalTrials.gov Identifier: NCT00143806     History of Changes
Other Study ID Numbers: 4513
First Submitted: August 31, 2005
First Posted: September 2, 2005
Last Update Posted: January 5, 2009
Last Verified: December 2008

Keywords provided by Rutgers, The State University of New Jersey:
psoriasis
cyclosporine
transition
alefacept

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Cyclosporins
Cyclosporine
Alefacept
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors