Assessment and Tracking of Long-term Alefacept Safety (ATLAS)
Subjects exposed to alefacept are to be enrolled. Subjects will be contacted every 6 months to gather general health information.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment and Tracking of Long-term Alefacept (LFA-3/IgG1 Fusion Protein) Safety (ATLAS)|
- To measure the rates of non-Hodgkin's lymphoma (NHL) and infections that require hospitalization occurring in psoriasis patients treated with alefacept [ Time Frame: At six month intervals for five years ] [ Designated as safety issue: No ]
- To estimate the rates of lung cancer, breast cancer (female), prostate cancer, colorectal cancer, melanoma and active tuberculosis within a population of patients with psoriasis treated with alefacept. [ Time Frame: At six month intervals for five years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2003|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
1. Amevive Exposure
Patients treated with alefacept for chronic plaque psoriasis
Drug: Alefacept exposure
There are no study-mandated tests, visits or clinical interventions after the 1st (enrolling) visit. After the patient is enrolled in the study, they will be contacted every 6 months to complete structured telephone interviews conducted by the ATLAS Study Center.
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|Study Director:||Vice President Medical Affairs||Astellas Pharma Global Development|