Alefacept in Subjects With Chronic Plaque Psoriasis Who Failed to Respond to Anti-TNF Therapy

Study Overview
=================
Brief Summary
-----------------
Study Status: Duke University Health System Institutional Review Board has received notification of study termination; final IRB closure date is 12/12/2008. Study enrollment is now closed. Enrollment Update: Only one subject was entered into this study out of an expected enrollment of 15 patients in this single site clinical trial. With no recruitment interest, the financial sponsor and Sponsor-PI chose to close the clinical trial.

Detailed Description
-----------------
This is an open-label study using alefacept in the treatment of patients with chronic plaque psoriasis who have not responded to treatment with an anti-TNF agent. Patients not responding to Enbrel® 50 mg weekly with a 75% reduction of Psoriasis Area and Severity Index (PASI) Score or a Physician Global Assessment (PGA) score of 'almost clear' or 'clear', will be treated with 15 mg alefacept intramuscularly (IM) once weekly for up to 20 weeks. Patients who have 'cleared' or 'almost cleared' at the end of 12 weeks of treatment with alefacept will have completed the 'standard treatment' phase of the study. Study subjects who have not responded to treatment during the initial 12 weeks will continue with alefacept therapy for an additional 8 weekly doses or until the subject has reached a PGA of 'almost clear' or 'clear'. Alefacept is FDA approved for this indication for 12 weeks of treatment and this clinical trial is extending the treatment window for up to 8 additional weeks. Because of this increased exposure to alefacept, all subjects will be carefully monitored while on treatment and followed post-treatment at 3, 4, 6, 9 and 12 months after the last dose of alefacept is given. Purpose: This open-label study will determine the safety and efficacy of Amevive® 15 mg IM weekly in subjects with chronic plaque psoriasis who have not sufficiently responded to etanercept, an anti-TNF agent. The plan also is to determine the length of response time to point of relapse and to determine the length of time before retreatment with alefacept is necessary. Patient Population: This study is for adult men and women, ages 18 to 80, with chronic plaque psoriasis. At the time of enrollment, the subject must have received 50 mg per week of Enbrel without achieving a response of 'almost clear' or 'clear' according to PGA or has not responded with a 75% reduction of PASI Score.

Official Title
-----------------
An Open-Label Study to Determine the Safety and Efficacy of Alefacept as Monotherapy in Subjects With Chronic Plaque Psoriasis Who Have Failed to Respond to Anti-TNF Therapy

Conditions
-----------------
Chronic Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: alefacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between ages of 18 and 80 years Subjects diagnosed with chronic plaque psoriasis who require systemic therapy. Must be receiving anti-TNF treatment without achieving response of 'almost clear' or 'clear' according to PGA or has not responded with 75% reduction PASI score. Must be willing to receive up to 20 weeks of IM injections weekly CD4 counts must be above 250 cells/mm3 at screening Exclusion Criteria: Diagnosis of unstable erythroderma or pustular psoriasis or guttate psoriasis Serious local infection or systemic infection 3 months prior to receiving study drug. Subjects with CD4 lymphocyte count less than 250 cells/mm3 at study entry

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alefacept 15 mg IM qweek<br>Alefacept will be given to subjects with plaque psoriasis who have failed treatment with Fnbrel. | Drug: alefacept<br>* Alefacept 15 mg IM once a week were to be administered for 12 weeks, which is the FDA approved dosage, duration, and frequency. This study allowed an additional 8 doses if subject did not achieve a 'clear' response with the original 12 weeks of treatment. Each enrolled subject must have failed a response to anti-TNF therapy prior to entering this study.<br>* Other names: Amevive;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Alefacept | Terminated study | 12 weeks (study terminated) |