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Transitioning From Cyclosporine to Alefacept in Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00143806
First received: August 31, 2005
Last updated: December 31, 2008
Last verified: December 2008
History of Changes
  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: 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:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 New Jersey
Biogen Idec
Investigators
Principal Investigator: Alice Gottlieb, MD, PhD University of Medicine and Dentistry New Jersey
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00143806     History of Changes
Other Study ID Numbers: 4513
Study First Received: August 31, 2005
Last Updated: December 31, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry 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
Pharmacologic Actions
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013