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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 29, 2007
First Posted Date April 2, 2007
Last Update Posted Date December 11, 2013
Study Start Date June 2003
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2008)
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 ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00454701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 3, 2009)
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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment and Tracking of Long-term Alefacept Safety
Official Title Assessment and Tracking of Long-term Alefacept (LFA-3/IgG1 Fusion Protein) Safety (ATLAS)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated with alefacept for chronic plaque psoriasis
Condition Psoriasis
Intervention Drug: Alefacept exposure
Observational
Other Names:
  • Amevive
  • ASP0485
Study Groups/Cohorts 1. Amevive Exposure
Patients treated with alefacept for chronic plaque psoriasis
Intervention: Drug: Alefacept exposure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 6, 2012)
1897
Original Enrollment Not Provided
Actual Study Completion Date February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Psoriasis patients who are prescribed alefacept consistent with product labeling are eligible for enrollment.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States,   Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00454701
Other Study ID Numbers 0485-CL-0001
C-736
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Astellas Pharma Inc
Study Sponsor Astellas Pharma Inc
Collaborators Not Provided
Investigators
Study Director: Vice President Medical Affairs Astellas Pharma Global Development
PRS Account Astellas Pharma Inc
Verification Date December 2013