Status:
TERMINATED
Alefacept in Subjects With Chronic Plaque Psoriasis Who Failed to Respond to Anti-TNF Therapy
Lead Sponsor:
John Murray
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Chronic Plaque Psoriasis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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. Enrollmen...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00953329
Start Date
February 1 2008
End Date
December 1 2008
Last Update
February 22 2013
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