Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis (AWARE-2)

February 27, 2013 updated by: Astellas Pharma Inc

Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study

The study is a prospective, multi-centre, observational study designed to assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study includes a bio-marker sub-study to determine differences in responders vs. non-responders. Additional consent is required for the sub-study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6J 5E5
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
      • Winnipeg, Manitoba, Canada, R3C 1R4
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E1A 2YA
      • Quispamsis, New Brunswick, Canada, E2E 4Y7
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3E1
      • St. Johns, Newfoundland and Labrador, Canada, A1C 2H5
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1Z4
    • Ontario
      • Hamilton, Ontario, Canada, L8K 6R5
      • London, Ontario, Canada, N6A 3H7
      • London, Ontario, Canada, N6H 1S9
      • Markham, Ontario, Canada, L3P 1A8
      • Oakville, Ontario, Canada, L6J 7W5
      • Peterborough, Ontario, Canada, K9J 1Z2
      • Toronto, Ontario, Canada, M4V2V6
      • Waterloo, Ontario, Canada, N2J 1C4
      • Welland, Ontario, Canada, L3C 3W4
    • Quebec
      • Alma, Quebec, Canada, G8B 2V5
      • Montreal, Quebec, Canada, H2K 4L5
      • Quebec City, Quebec, Canada, G1J 1X7
      • St. Hyacinthe, Quebec, Canada, J2S 6L6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Canadian subjects with moderate to severe chronic plaque psoriasis for which Amevive is clinically indicated

Description

Inclusion Criteria:

  • Subjects with moderate to severe chronic plaque psoriasis who receive a new prescription for alefacept

Exclusion Criteria:

  • Subjects with a contraindication to alefacept
  • Subjects with a history of cancer except for adequately treated basal cell carcinoma (maximum of 2 lesions)
  • Subjects with any active cancer, including skin cancer
  • Subjects having a serious local infection (eg. cellulitis, abscess) or serious systemic infection (eg. pneumonia, septicemia, tuberculosis), within the 3 months prior to the first dose of alefacept.
  • Subjects known to be infected with the AIDS virus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
1. Amevive Exposure
Canadian subjects with moderate to severe chronic plaque psoriasis
Drug: Amevive exposure
Commercial alefacept prescribed by Physician
Other Names:
  • ASP0485
  • alefacept

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis
Time Frame: 8 Weeks following last dose of each treatment course throughout study
8 Weeks following last dose of each treatment course throughout study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index
Time Frame: 8 Weeks following last dose of each treatment course throughout study
8 Weeks following last dose of each treatment course throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Astellas Pharma Canada, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A.W.A.R.E.-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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