Assessment and Tracking of Long-term Alefacept Safety

Assessment and Tracking of Long-term Alefacept (LFA-3/IgG1 Fusion Protein) Safety (ATLAS)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00454701

Acronym

ATLAS

Enrollment

1897

Registered

2007-04-02

Start date

2003-06-30

Completion date

2012-02-29

Last updated

2013-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Psoriasis, Alefacept, Amevive®, Drug exposure

Brief summary

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

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.

Interventions

DRUGAlefacept exposure

Observational

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To measure the rates of non-Hodgkin's lymphoma (NHL) and infections that require hospitalization occurring in psoriasis patients treated with alefacept	At six month intervals for five years

Secondary

Measure	Time frame
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.	At six month intervals for five years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026