Community Based Trial for AMEVIVE®

Study Overview
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Brief Summary
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To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.

Detailed Description
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Male and female subjects at least 18 years of age with moderate to severe plaque psoriasis treated with 12 weeks of alefacept 15 mg IM and who have not achieved the desired response. Dosing Groups: Subjects will receive either 4, 8, or 12 doses of alefacept 15 mg IM weekly immediately (within 14 days) following a standard 12-dose course of AMEVIVE® 15 mg IM. Determination of number of doses will be based on physician qualitative assessment at weeks 4 and 8.

Official Title
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An Open-Label Community-Based Study to Determine the Safety and Efficacy of an Extended Course of Alefacept, Following a Standard 12-Week Course of Amevive®, With Commonly Used Clinical Assessment Tools

Conditions
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Moderate to Severe Chronic Plaque Psoriasis

Intervention / Treatment
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* Drug: Alefacept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must give written informed consent. Must have had moderate, moderately severe or severe chronic plaque psoriasis as determined by the investigator prior to initial treatment (baseline) with AMEVIVE. Must be 18 years of age or older. Must have completed a standard 12-week course of AMEVIVE and have received at least 10 doses. Response to current AMEVIVE therapy must be less than a desired response as determined by the physician, and subject and some residual psoriasis must be present. Exclusion Criteria: Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or not willing to practice effective contraception during the study. Nursing mothers, pregnant women, and women planning to become pregnant Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy. Treatment with another investigational drug, or approved therapy for investigational use, within 3 months of investigational drug administration. Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mycophenolate mofetil or other systemic immunosuppressant agents within 4 weeks of investigational drug administration. Treatment with Ultraviolet B (UVB) phototherapy or Psoralen + Ultraviolet A (PUVA), within 4 weeks of investigational drug administration. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug. History of >3 cutaneous squamous cell carcinomas or any systemic malignancy. Skin lesions suspicious for malignancy. Known HIV, viral hepatitis, or tuberculosis infection. History of severe allergic or anaphylactic reactions. ALT or AST greater than three times the upper limit of normal. Significantly abnormal hematology (hemoglobin, hematocrit, platelets, white blood cells), as determined by the investigator. CD4+ T lymphocyte count at screening visit less than 250 cells/mm3. Known hypersensitivity to AMEVIVE or any of its components. Subject's inability to comply with study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Alefacept<br>* IM<br>* Other names: ASP0485;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of treating subjects with up to 12 additional doses of alefacept 15 mg IM following a standard 12-week course of AMEVIVE. |  | 16 weeks, 20 weeks or 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study, |  | End of study | 
| The cumulative change in PQA score from screening visit to best PQA score at any time in the study, |  | End of study | 
| Association of the total number of doses received with the best efficacy reached, as assessed by PQA score, at any time during the study, |  | End of study | 
| Time to re-treatment for subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study, |  | End of study | 
| The cumulative change in SSA score from screening visit to best SSA score at any time in the study, |  | End of study | 
| Association of the total number of doses received with the best efficacy reached, as assessed by SSA score, at any time during the study, and |  | End of study | 
| Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively. |  | End of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extended dosing, alefacept