Transitioning From Cyclosporine to Alefacept in Psoriasis - Full Text View

Sponsors and Collaborators:	University of Medicine and Dentistry New Jersey Biogen Idec
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00143806

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 II

MedlinePlus related topics: Psoriasis

Drug Information available for: Cyclosporin Cyclosporine Alefacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Investigator-Initiated, Use Study of Alefacept (Amevive) in Combination With Tapering Doses of Cyclosporine in Patients With Moderate to Severe Psoriasis

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

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

Keywords provided by University of Medicine and Dentistry New Jersey:

psoriasis
cyclosporine
transition
alefacept

Study placed in the following topic categories:

Alefacept
Cyclosporine
Skin Diseases
Clotrimazole
Psoriasis

Miconazole
Tioconazole
Cyclosporins
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009