CClinicalTrials.gg
CompletedNCT00143806Updated Jan 5, 2009

Transitioning From Cyclosporine to Alefacept in Psoriasis

A Phase 2 interventional study of Transitioning patients from cyclosporine to alefacept in Psoriasis, sponsored by University of Medicine and Dentistry of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-01-05.

Sponsored by University of Medicine and Dentistry of New Jersey · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Psoriasis

Browse trials for

Keywords

  • psoriasis
  • cyclosporine
  • transition
  • alefacept
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 13 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

University of Medicine and Dentistry of New Jersey is the lead sponsor of 103 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants

Interventions

  • DrugTransitioning patients from cyclosporine to alefacept
06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • UMDNJ Clinical Research Center
    New Brunswick, New Jersey 08903, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00143806
Lead sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Biogen
First posted
Sep 2, 2005
Start date
Oct 2003
Completion
May 2007
Last update
Jan 5, 2009

Study contacts

Alice Gottlieb, MD, PhD
principal investigator · Rutgers, The State University of New Jersey

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion