Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis (AWARE-2)
This study has been terminated.
(The study was terminated early due to insufficient subject enrolment in order to meet the primary and secondary endpoints)
Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00795353
First received: November 11, 2008
Last updated: February 27, 2013
Last verified: March 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Plaque Psoriasis |
Drug: Amevive exposure |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
10mL blood sample - Biomarker Substudy only
| Enrollment: | 64 |
| Study Start Date: | July 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1. Amevive Exposure
Canadian subjects with moderate to severe chronic plaque psoriasis
|
Drug: Amevive exposure
Commercial alefacept prescribed by Physician
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Canadian subjects with moderate to severe chronic plaque psoriasis for which Amevive is clinically indicated
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795353
Locations
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6J 5E5 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R3C 0N2 | |
| Winnipeg, Manitoba, Canada, R3C 1R4 | |
| Canada, New Brunswick | |
| Bathurst, New Brunswick, Canada, E1A 2YA | |
| Quispamsis, New Brunswick, Canada, E2E 4Y7 | |
| Canada, Newfoundland and Labrador | |
| St. Johns, Newfoundland and Labrador, Canada, A1C 2H5 | |
| St. Johns, Newfoundland and Labrador, Canada, A1B 3E1 | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada, B3H 1Z4 | |
| Canada, 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 | |
| Canada, Quebec | |
| Alma, Quebec, Canada, G8B 2V5 | |
| Montreal, Quebec, Canada, H2K 4L5 | |
| Quebec City, Quebec, Canada, G1J 1X7 | |
| St. Hyacinthe, Quebec, Canada, J2S 6L6 | |
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Canada, Inc.
Investigators
| Study Director: | Use Central Contact | Astellas Pharma Canada, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00795353 History of Changes |
| Other Study ID Numbers: | A.W.A.R.E.-2 |
| Study First Received: | November 11, 2008 |
| Last Updated: | February 27, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Astellas Pharma Inc:
|
plaque psoriasis psoriasis alefacept Amevive |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Alefacept |
Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013