Alefacept Mechanism of Action in Psoriasis
This study has been completed.
Information provided by:
Rutgers, The State University of New Jersey
First received: September 6, 2005
Last updated: August 6, 2008
Last verified: August 2008
To determine the mechanism of action of alefacept in patients with psoriasis.
Drug: Mechanism of action of alefacept
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||In Vivo Induction of T Cell Apoptosis by Alefacept (LFA-3/IgG1 Fusion Protein, Amevive) in Patients With Psoriasis: An Investigator-Initiated, Open-Label, Mechanism of Action Study
Primary Outcome Measures:
- To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo
Secondary Outcome Measures:
- To determine if apoptosis of circulating or plaque T cells in vivo is a better predictor of clinical response than are circulating CD4 T cell counts.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
The purpose of the study is to better understand the mechanism of action of an FDA approved drug (alefacept). Subjects enrolled will be given alefacept 7.5 mg intravenously on a weekly basis for 12 weeks. Response is assessed by improvement in the PASI score. The responders will get no further treatment and the nonresponders will receive additional 4 weeks of therapy. Skin biopsies will be obtained throughout the study and T-cell apoptosis will be correlated to clinical response. There is no placebo group. The duration of the study is approximately 1 year.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Alefacept is indicated for the treatment of adult patients (18 years or older) with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Patients must have at least one plaque of least 2.5 cm in diameter (for biopsies).
- CD4 < 400/ml
- WBC less than lower level of normal for the reporting laboratory
- < 5% Body Surface Area involved with psoriasis
- Serious infection e.g., latent or active tuberculosis
- History of AIDS or Hepatitis B,C, all internal cancers, lymphoma, untreated cutaneous basal or squamous cell carcinoma
- Systemic anti-psoriasis medications and phototherapy within 28 days of the first dose of Alefacept
- Topical anti-psoriasis medications within 14 days of the first dose of Alefacept, except for moisturizers, tar shampoos (exception, Elidel is permitted to be applied on the face, groin and axillae areas. These areas are not biopsied.)
- Inability to understand consent form or comply with study requirements
- Pregnancy or lactation
- Concurrent medical illness that would make participation in this clinical trial ill-advised
- Any contraindications to using alefacept
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150982
|UMDNJ Clinical Research Center
|New Brunswick, New Jersey, United States, 08903 |
University of Medicine and Dentistry of New Jersey
||Alice Gottlieb, MD, PhD
||Rutgers, The State University of New Jersey
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 6, 2005
||August 6, 2008
||United States: Institutional Review Board
Keywords provided by Rutgers, The State University of New Jersey:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2014
Skin Diseases, Papulosquamous