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Assessment and Tracking of Long-term Alefacept Safety (ATLAS)

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ClinicalTrials.gov Identifier: NCT00454701
Recruitment Status : Terminated (The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive)
First Posted : April 2, 2007
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
Subjects exposed to alefacept are to be enrolled. Subjects will be contacted every 6 months to gather general health information.

Condition or disease Intervention/treatment
Psoriasis Drug: Alefacept exposure

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 1897 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment and Tracking of Long-term Alefacept (LFA-3/IgG1 Fusion Protein) Safety (ATLAS)
Study Start Date : June 2003
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Group/Cohort Intervention/treatment
1. Amevive Exposure
Patients treated with alefacept for chronic plaque psoriasis
Drug: Alefacept exposure
Observational
Other Names:
  • Amevive
  • ASP0485



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with alefacept for chronic plaque psoriasis
Criteria

Inclusion Criteria:

  • Psoriasis patients who are prescribed alefacept consistent with product labeling are eligible for enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454701


  Show 268 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Vice President Medical Affairs Astellas Pharma Global Development

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00454701     History of Changes
Other Study ID Numbers: 0485-CL-0001
C-736
First Posted: April 2, 2007    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by Astellas Pharma Inc:
Psoriasis
Alefacept
Amevive®
Drug exposure

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Dermatologic Agents