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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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To assess the efficacy and safety of Alefacept compared to placebo for the treatment of Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and inappropriate
Patients who completed the initial 24-week treatment course (12 weeks of weekly dosing following b y 12 weeks of follow-up) and met the eligibility criteria continued in the 24-week open label extension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Course A1 | Experimental |
| |
| Course A2 | Placebo Comparator |
| |
| Course B | Experimental | Open label extension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alefacept | Drug | Intramuscular (IM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50 | 14 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving a PASI score of ≥ 50 any time during study | Throughout study | |
| Proportion of patients achieving a PASI score of ≥ 75 | 14 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use central contact | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irvine | California | 92697 | United States | |||
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| placebo | Drug | Intramuscular (IM) |
|
| Santa Monica |
| California |
| 90404 |
| United States |
| Omaha | Nebraska | 68144 | United States |
| New Brunswick | New Jersey | 08903 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Goodlettsville | Tennessee | 37072 | United States |
| Dallas | Texas | 75246 | United States |
| Salt Lake City | Utah | 84132 | United States |
| Norfolk | Virginia | 23507 | United States |
| Seattle | Washington | 98104 | United States |
| Vienna | 1090 | Austria |
| Brussels | 1070 | Belgium |
| Edegem | 2650 | Belgium |
| Liège | 4020 | Belgium |
| Edmonton | Alberta | T5J 3S9 | Canada |
| St. John's | Newfoundland and Labrador | A1B 4S8 | Canada |
| Halifax | Nova Scotia | B3H 1Z4 | Canada |
| Concord | Ontario | L4K 5V2 | Canada |
| Hamilton | Ontario | L8N 1V6 | Canada |
| London | Ontario | N6K 1L6 | Canada |
| Windsor | Ontario | N8W 5L7 | Canada |
| Montreal | Quebec | H2K 4L5 | Canada |
| Sainte-Foy | Quebec | G1V 4X7 | Canada |
| Bochum | 44791 | Germany |
| Dresden | 01307 | Germany |
| Düsseldorf | 40225 | Germany |
| Essen | 45147 | Germany |
| Frankfurt | 60596 | Germany |
| Göttingen | 37075 | Germany |
| Hamburg | 20246 | Germany |
| Hanover | 30449 | Germany |
| Homburg-Saar | 66421 | Germany |
| Mannheim | 68135 | Germany |
| Münster | 48149 | Germany |
| 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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