Back to resultsTransitioning From Cyclosporine to Alefacept in Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Transitioning patients from cyclosporine to alefacept
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, cyclosporine, transition, alefacept
Eligibility 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
Sites / Locations
- UMDNJ Clinical Research Center
Outcomes
Primary Outcome Measures
Static physicians global assessment (PGA) and quality of life as measured by DLQI
Secondary Outcome Measures
Full Information
NCT ID
NCT00143806
First Posted
August 31, 2005
Last Updated
December 31, 2008
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Biogen
1. Study Identification
Unique Protocol Identification Number
NCT00143806
Brief Title
Transitioning From Cyclosporine to Alefacept in Psoriasis
Official Title
Investigator-Initiated, Use Study of Alefacept (Amevive) in Combination With Tapering Doses of Cyclosporine in Patients With Moderate to Severe Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, cyclosporine, transition, alefacept
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Transitioning patients from cyclosporine to alefacept
Primary Outcome Measure Information:
Title
Static physicians global assessment (PGA) and quality of life as measured by DLQI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Gottlieb, MD, PhD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMDNJ Clinical Research Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
12. IPD Sharing Statement
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Transitioning From Cyclosporine to Alefacept in Psoriasis
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