Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Mount Sinai School of Medicine Astellas Pharma Inc |
---|---|
Information provided by: | Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00815633 |
The purpose of this study is to determine whether the biologic medication alefacept (Amevive) is effective and safe in the treatment of Pityriasis Rubra Pilaris.
Condition | Intervention | Phase |
---|---|---|
Pityriasis Rubra Pilaris |
Drug: Alefacept |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris. |
Estimated Enrollment: | 10 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Alefacept: Experimental
Treatment Group (only one group)
|
Drug: Alefacept
15mg intramuscular injection weekly for 12 weeks
|
Pityriasis Rubra Pilaris (PRP) is a therapeutic challenge, and many different medication regimens exist to treat the condition. Clinical response is variable, and no single treatment has emerged as a leading therapy. Biologic agents have emerged as effective treatments for many skin diseases, including psoriasis. Given the clinical overlap between PRP and psoriasis, it is logical to attempt to use these agents for PRP. Since the majority of patients with PRP are unresponsive to current therapies, new treatment modalities must be evaluated. This study will evaluate the treatment of adult 30 years or older with a diagnosis of PRP, either subtypes 1 or 2. In this study, the safety and efficacy of alefacept will be evaluated in adult patients with PRP refractory to current treatments. Alefacept is a dimeric fusion protein containing the CD2 extracellular binding region of human leukocyte function antigen-3 (LFA-3) linked to the Fc portion of human IgG1. The drug binds to the T-lymphocyte antigen CD2 and blocks its interaction with LFA-3 on antigen presenting cells in the body. The CD2/LFA-3 interaction is a key co-stimulatory signal in the activation of T-lymphocytes central to the pathophysiology of psoriasis. It is theorized this interaction plays a role in the pathophysiology of PRP. Alefacept is currently approved for the treatment of adults with moderate to severe, chronic, plaque-type psoriasis. The medication is administered as weekly intramuscular injections for 12 week courses. In this study, a dose of 15mg alefacept will be administered intramuscularly at weekly intervals for 12 weeks. This is the dosing regimen currently approved for the treatment of psoriasis. Patients will be followed for a total of 24 weeks.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Mount Sinai School of Medicine | Recruiting |
New York, New York, United States, 10029 | |
Contact: Giselle Singer 212-241-3288 giselle.singer@mssm.edu | |
Contact: Jason Emer, MD 212-241-3288 jason.emer@mssm.edu | |
Principal Investigator: Joshua Zeichner, MD | |
Sub-Investigator: Jason Emer, MD |
Principal Investigator: | Joshua Zeichner, MD | Mount Sinai School of Medicine |
Responsible Party: | Mount Sinai School of Medicine ( Joshua Zeichner, MD ) |
Study ID Numbers: | 08-0514, JM-08-001 |
Study First Received: | December 29, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00815633 |
Health Authority: | United States: Food and Drug Administration |
PRP Pityriasis Rubra Pilaris Amevive Alefacept |
Biologic Immunosuppressant Severe skin disease |
Alefacept Exfoliative dermatitis Pityriasis Rubra Pilaris Skin Diseases Pityriasis rubra pilaris |
Skin Diseases, Eczematous Dermatitis, Exfoliative Pityriasis Skin Diseases, Papulosquamous Dermatitis |
Therapeutic Uses Dermatologic Agents Pharmacologic Actions |