Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: August 31, 2006
Last updated: November 15, 2011
Last verified: November 2011


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.

Condition Phase
Plaque Psoriasis
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Understand how AMEVIVE is used in routine clinical practice/real world setting [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment: 426
Study Start Date: June 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Dermatologic patients in Canada for which Amevive is clinically indicated


Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Dermatologic patients in Canada


Inclusion Criteria:

  • Amevive is clinically indicated for the patient

Exclusion Criteria:

  • Amevive is contraindicated for the patient
  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 identifier: NCT00371774

Canada, Alberta
Calgary, Alberta, Canada, T3A 2N1
Calgary, Alberta, Canada, T2S 3B3
Edmonton, Alberta, Canada, T5J 3S9
Edmonton, Alberta, Canada, T5K 1X3
Canada, British Columbia
Surrey, British Columbia, Canada, V3R6A7
Vancouver, British Columbia, Canada, V5Z 4E8
Vancouver, British Columbia, Canada, V5Z 3Y1
Victoria, British Columbia, Canada, V8V 3P9
Victoria, British Columbia, Canada, V8V 4X3
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C 8X3
Saint John, New Brunswick, Canada, E2M 3W5
Canada, 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
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 124
Canada, Ontario
Barrie, Ontario, Canada, L7M 6L7
Concord, Ontario, Canada, L4K 5V2
Hamilton, Ontario, Canada, L8N 3H7
London, Ontario, Canada, N6H 1S9
London, Ontario, Canada, N6A 3H7
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
Canada, Quebec
Montreal, Quebec, Canada, H2K 4L5
Montreal, Quebec, Canada, H3G 1A1
Sainte-Foy, Quebec, Canada, G1V 4X7
Quebec, Canada, G1J 1X7
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma Canada, Inc.
  More Information