Assessment and Tracking of Long-term Alefacept Safety - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by (Responsible Party):	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00454701

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 IV

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:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Cancer Psoriasis

Drug Information available for: Alefacept

U.S. FDA Resources

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 ]

Estimated Enrollment:	5000
Study Start Date:	July 2003
Estimated Study Completion Date:	December 2025
Estimated Primary Completion Date:	December 2025 (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

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

Contacts

Contact: Clinsys	866-285-2755
Contact: Astellas Pharma Global Development		clintrials.info@us.astellas.com

Show 382 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Vice President Medical Affairs

Astellas Pharma Global Development

More 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 8, 2011
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 February 09, 2012