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To Study the Use of Humanized CD25 in Preventing the Relapse of Psoriasis Vulgaris

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Rockefeller University
PDL BioPharma, Inc.
Information provided by: Rockefeller University
ClinicalTrials.gov Identifier: NCT00050661
  Purpose

This study is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse.


Condition Intervention Phase
Psoriasis
Drug: Daclizumab
Phase I
Phase II

MedlinePlus related topics:   Psoriasis   

Drug Information available for:   Cyclosporine    Cyclosporin    Dacliximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody/ Placebo to Prevent Relapse of Psoriasis Vulgaris Following NBUVB Therapy

Further study details as provided by Rockefeller University:

Estimated Enrollment:   30
Study Start Date:   October 1997
Estimated Study Completion Date:   December 2004

Detailed Description:

The first part of the study involves NB-UVB light treatment, a well-established treatment to treat psoriasis. In the second part, we are testing a drug known as Humanized CD25 Monoclonal Antibody (anti-TAC) or placebo to prevent disease relapse. Anti-TAC is an injectable medicine that is also designed to treat psoriasis by blocking a part of the immune system that we believe contributes to the disease.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

  • extensive active psoriasis vulgaris, body surface area more than 10% if accompanied by psoriatic arthritis
  • negative hepatitis and HIV
  • no treatment with systemic drugs for 1 month prior to the start of a study
  • no treatment with topical medications for 2 weeks prior to the start of a study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050661

Locations
United States, New York
Rockefeller University    
      New York, New York, United States, 10021
Rockefeller University Hospital    
      New York, New York, United States, 10021

Sponsors and Collaborators
Rockefeller University
PDL BioPharma, Inc.

Investigators
Principal Investigator:     James Krueger, MD, PHD     Rockefeller University    
  More Information


Rockefeller University Hospital Clinical Studies  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   JKR-0337
First Received:   December 17, 2002
Last Updated:   April 18, 2007
ClinicalTrials.gov Identifier:   NCT00050661
Health Authority:   United States: Food and Drug Administration

Keywords provided by Rockefeller University:
psoriasis  
Cyclosporine  
Daclizamub  
anti-TAC  
dermatology
skin
lesions

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Cyclosporine
Skin Diseases
Psoriasis
Daclizumab
Cyclosporins
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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