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The study was terminated early due to insufficient subject enrolment in order to meet the primary and secondary endpoints
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| Name | Class |
|---|---|
| Astellas Pharma Canada, Inc. | INDUSTRY |
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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 includes a bio-marker sub-study to determine differences in responders vs. non-responders. Additional consent is required for the sub-study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Amevive Exposure | Canadian subjects with moderate to severe chronic plaque psoriasis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amevive exposure | Drug | Commercial alefacept prescribed by Physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis | 8 Weeks following last dose of each treatment course throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index | 8 Weeks following last dose of each treatment course throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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Canadian subjects with moderate to severe chronic plaque psoriasis for which Amevive is clinically indicated
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Canada, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edmonton | Alberta | T6J 5E5 | Canada | |||
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10mL blood sample - Biomarker Substudy only
| Winnipeg |
| Manitoba |
| R3C 0N2 |
| Canada |
| Winnipeg | Manitoba | R3C 1R4 | Canada |
| Bathurst | New Brunswick | E1A 2YA | Canada |
| Quispamsis | New Brunswick | E2E 4Y7 | Canada |
| St. John's | Newfoundland and Labrador | A1B 3E1 | Canada |
| St. John's | Newfoundland and Labrador | A1C 2H5 | Canada |
| Halifax | Nova Scotia | B3H 1Z4 | Canada |
| Hamilton | Ontario | L8K 6R5 | Canada |
| London | Ontario | N6A 3H7 | Canada |
| London | Ontario | N6H 1S9 | Canada |
| Markham | Ontario | L3P 1A8 | Canada |
| Oakville | Ontario | L6J 7W5 | Canada |
| Peterborough | Ontario | K9J 1Z2 | Canada |
| Toronto | Ontario | M4V2V6 | Canada |
| Waterloo | Ontario | N2J 1C4 | Canada |
| Welland | Ontario | L3C 3W4 | Canada |
| Alma | Quebec | G8B 2V5 | Canada |
| Montreal | Quebec | H2K 4L5 | Canada |
| Québec | Quebec | G1J 1X7 | Canada |
| Saint-Hyacinthe | Quebec | J2S 6L6 | Canada |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077944 | Alefacept |
| ID | Term |
|---|---|
| D018968 | CD58 Antigens |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008565 | Membrane Proteins |
| D011993 | Recombinant Fusion Proteins |
| D011994 | Recombinant Proteins |
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