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Study of the Drug Efalizumab (Raptiva), for Adult Patients with Moderate to Severe Plaque Psoriasis - Article


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Efalizumab

Raptiva



Clinical Trial: Study of the Drug Efalizumab (Raptiva), for Adult Patients with Moderate to Severe Plaque Psoriasis

This study is currently recruiting patients.

Sponsors and Collaborators: Rockefeller University
Genentech
Information provided by: Rockefeller University

Purpose

Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is to study the action and the effects of Efalizumab, on psoriasis. This medication has been studied extensively and has been found to be effective and safe in the treatment of psoriasis. The eligible patient will have 10% of his/her body surface area involved with psoriasis vulgaris.
Condition Intervention Phase
Psoriasis
 Drug: Efalizumab
Phase III

MedlinePlus related topics:  Psoriasis

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title: A Phase IIIB Study to Evaluate the Mechanism of Action of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults with Moderate to Severe Plaque Psoriasis who are Candidates for Systemic Therapy

Further Study Details: 

Expected Total Enrollment:  30

Study start: October 2003

The eligible patient will receive the drug Efalizumab, weekly for 12 weeks, by injection. The patient will be seen weekly for 12 weeks and every other week for the 12 weeks of follow up. At those visits, the patient can expect that a physical and skin exam will be done. At specific weeks, blood work will be drawn, clinical photography taken and a skin biopsy done. Two types of skin biopsies will be done after local anesthesia has been administered. One is a punch biopsy where a small piece of skin will be taken, the approximate size of a pencil eraser. The second type of skin biopsy is shave biopsy, where a postage sized piece of skin will be taken.

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Men and women with 10% of body surface area involved with psoriasis vulgaris

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00115076


New York
      Rockefeller University, New York,  New York,  10021,  United States; Recruiting
Patricia Gilleaudeau, RN,MSN,FNP  212-327-8333    gilleap@rockefeller.edu 
Mary M. Sullivan-Whalen, RN,MSN,FNP  212-437-7212    whalems@rockefeller.edu 
James G. Krueger, MD,PhD,  Principal Investigator

More Information

Study ID Numbers:  JKR-0511-0604
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 20, 2005
ClinicalTrials.gov Identifier:  NCT00115076
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05

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November 18, 2008



Page Updated: September 6, 2005
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