Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Rush University Medical Center Astellas Pharma US, Inc. |
---|---|
Information provided by: | Rush University Medical Center |
ClinicalTrials.gov Identifier: | NCT00832585 |
This study will assess the safety, tolerability, and efficacy of Alefacept in patient with moderate to severe atopic dermatitis who could not be adequately controlled with topical therapies.
Condition | Intervention | Phase |
---|---|---|
Atopic Dermatitis |
Drug: Alefacept |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV, Open Label Study to Evaluate the Safety and Efficacy of Intramuscular (IM) Alefacept (Amevive) 15mg/wk in Subjects 18 Years and Older With Moderate to Severe Atopic Dermatitis |
Estimated Enrollment: | 10 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Alefacept: Experimental
Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes.
|
Drug: Alefacept
Alefacept 15mg IM every week for 12 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
EXCLUSION CRITERIA
Subjects with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled in the study
Exclusion Criteria:
-
Contact: Claudia R. Malik, BSN | 312-563-4001 | claudia.riechelamnn-malik@rush.edu |
Contact: Danica Uzelac, BSN | 312-563-4001 | danica.uzelac@rush.edu |
United States, Illinois | |
Rush University Medical Center - Department of Dermatology | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Claudia R Malik, BSN 312-563-4001 claudia.riechelmann-malik@rush.edu | |
Contact: Danica Uzelac, BSN 312-563-4001 danica.uzelac@rush.edu | |
Principal Investigator: Michael D Tharp, MD |
Principal Investigator: | Michael D. Tharp, MD | Rush University Medical Center |
Responsible Party: | Rush University Medical Center ( Michael D. Tharp ) |
Study ID Numbers: | AC 07-001 |
Study First Received: | January 28, 2009 |
Last Updated: | June 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00832585 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Atopic Dermatitis chronic skin |
Alefacept Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases |
Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |
Alefacept Dermatitis, Atopic Skin Diseases Immune System Diseases Pharmacologic Actions Hypersensitivity Genetic Diseases, Inborn |
Therapeutic Uses Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatologic Agents Dermatitis |