NCT00143806

Brief Summary

The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 5, 2009

Status Verified

December 1, 2008

First QC Date

August 31, 2005

Last Update Submit

December 31, 2008

Conditions

Psoriasis

Keywords

psoriasiscyclosporinetransitionalefacept

Outcome Measures

Primary Outcomes (1)

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

Interventions

Transitioning patients from cyclosporine to alefaceptDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMDNJ Clinical Research Center

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alice Gottlieb, MD, PhD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

October 1, 2003

Study Completion

May 1, 2007

Last Updated

January 5, 2009

Record last verified: 2008-12

Locations

US(1)