Chronic Plaque Psoriasis Clinical Trial
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
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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