Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program

November 15, 2011 updated by: Astellas Pharma Inc

Purpose:

To develop a real time national clinical database to support and share best practices,

  1. To generate hypotheses for future clinical research
  2. To understand how AMEVIVE is used in routine clinical practice/real world setting.

Each patient visit will include the following observational endpoints:

  1. AMEVIVE dosing
  2. Number of courses
  3. Concomitant treatment
  4. Response to treatment (patient and physician global assessments)
  5. Status of other psoriasis-related medical conditions
  6. Time to re-treatment.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

426

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
      • Quebec, Canada, G1J 1X7
    • Alberta
      • Calgary, Alberta, Canada, T2S 3B3
      • Calgary, Alberta, Canada, T3A 2N1
      • Edmonton, Alberta, Canada, T5J 3S9
      • Edmonton, Alberta, Canada, T5K 1X3
    • British Columbia
      • Surrey, British Columbia, Canada, V3R6A7
      • Vancouver, British Columbia, Canada, V5Z 3Y1
      • Vancouver, British Columbia, Canada, V5Z 4E8
      • Victoria, British Columbia, Canada, V8V 3P9
      • Victoria, British Columbia, Canada, V8V 4X3
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 1R4
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
      • Saint John, New Brunswick, Canada, E2M 3W5
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1B 3A1
      • St. John's, Newfoundland and Labrador, Canada, A1B 3E1
      • St. John's, Newfoundland and Labrador, Canada, A1B 4S8
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 124
    • Ontario
      • Barrie, Ontario, Canada, L7M 6L7
      • Concord, Ontario, Canada, L4K 5V2
      • Hamilton, Ontario, Canada, L8N 3H7
      • London, Ontario, Canada, N6A 3H7
      • London, Ontario, Canada, N6H 1S9
      • Markham, Ontario, Canada, L3P 1A8
      • Oakville, Ontario, Canada, L6K 1E1
      • Toronto, Ontario, Canada, M5S 1B6
      • Waterloo, Ontario, Canada, N2J 1C4
      • Windsor, Ontario, Canada, N8W 5L7
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
      • Montreal, Quebec, Canada, H3G 1A1
      • Sainte-Foy, Quebec, Canada, G1V 4X7

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

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Dermatologic patients in Canada

Description

Inclusion Criteria:

  • Amevive is clinically indicated for the patient

Exclusion Criteria:

  • Amevive is contraindicated for the patient

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
1
Dermatologic patients in Canada for which Amevive is clinically indicated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Understand how AMEVIVE is used in routine clinical practice/real world setting
Time Frame: End of study
End of study

Collaborators and Investigators

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

Sponsor

Astellas Pharma 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.

General Publications

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

June 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

August 31, 2006

First Submitted That Met QC Criteria

September 1, 2006

First Posted (Estimate)

September 4, 2006

Study Record Updates

Last Update Posted (Estimate)

November 17, 2011

Last Update Submitted That Met QC Criteria

November 15, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA-08

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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