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

This study has been terminated.
(The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00454701
First received: March 29, 2007
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Psoriasis
Drug: Alefacept exposure
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment and Tracking of Long-term Alefacept (LFA-3/IgG1 Fusion Protein) Safety (ATLAS)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1897
Study Start Date: June 2003
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1. Amevive Exposure
Patients treated with alefacept for chronic plaque psoriasis
Drug: Alefacept exposure
Observational
Other Names:
  • Amevive
  • ASP0485

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454701

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

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00454701     History of Changes
Other Study ID Numbers: 0485-CL-0001, C-736
Study First Received: March 29, 2007
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board
Canada: Health Canada

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014