Alefacept Mechanism of Action in Psoriasis
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
1 other identifier
interventional
9
1 country
1
Brief Summary
To determine the mechanism of action of alefacept in patients with psoriasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2003
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedAugust 7, 2008
August 1, 2008
September 6, 2005
August 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Medicine and Dentistry of New Jerseylead
- Biogencollaborator
Study Sites (1)
UMDNJ Clinical Research Center
New Brunswick, New Jersey, 08903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alice Gottlieb, MD, PhD
Rutgers, The State University of New Jersey
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
September 1, 2003
Study Completion
February 1, 2005
Last Updated
August 7, 2008
Record last verified: 2008-08