Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00371774
First received: August 31, 2006
Last updated: November 15, 2011
Last verified: November 2011
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Purpose
Purpose:
To develop a real time national clinical database to support and share best practices,
- To generate hypotheses for future clinical research
- To understand how AMEVIVE is used in routine clinical practice/real world setting.
Each patient visit will include the following observational endpoints:
- AMEVIVE dosing
- Number of courses
- Concomitant treatment
- Response to treatment (patient and physician global assessments)
- Status of other psoriasis-related medical conditions
- Time to re-treatment.
| 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) |
| Groups/Cohorts |
|---|
|
1
Dermatologic patients in Canada for which Amevive is clinically indicated
|
Eligibility| 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
Criteria
Inclusion Criteria:
- Amevive is clinically indicated for the patient
Exclusion Criteria:
- Amevive is contraindicated for the patient
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371774
Locations
| 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 4S8 | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3E1 | |
| 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 | |
| Canada | |
| Quebec, Canada, G1J 1X7 | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Use Central Contact | Astellas Pharma Canada, Inc. |
More Information
Additional Information:
Publications:
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00371774 History of Changes |
| Obsolete Identifiers: | NCT00214799 |
| Other Study ID Numbers: | CA-08 |
| Study First Received: | August 31, 2006 |
| Last Updated: | November 15, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Astellas Pharma Inc:
|
Psoriasis Plaque Psoriasis Amevive® alefacept |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Alefacept |
Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013