Chronic Plaque Psoriasis Clinical Trial
Official title:
Open-Label Study to Assess the Safety and Efficacy of Apremilast in Patients With Chronic Plaque Psoriasis Who Have Failed One Course of Biologic Therapy.
This is a Phase II, open label, investigator-initiated study to be done at Duke University Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have failed Biologic Therapy with Apremilast 30 mg BID for 24 weeks. At the time of enrollment, the patient must have received biologic therapy without achieving a response of "almost clear" or "clear" according to PGA or has not responded with a 75% reduction of PASI score. Once deemed eligible, subjects will return for a baseline visit and receive Apremilast therapy and instructions. Subjects will be treated at weeks 0,4,8,12,16,20 and 24; subjects will be evaluated 28 days after last dose of Apremilast for safety and efficacy.
Data Analysis Data will be analyzed and reported after all subjects have completed follow-up
phase of study. All subsequent data collected will be analyzed and reported in a follow-up
clinical report.
Data & Safety Monitoring Dr. Murray will be following all laboratory values and adverse
events during this trial. In addition, Celgene will provide a study monitor to, at regular
intervals, review all data. All data will be reported to Celgene.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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