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| ID | Type | Description | Link |
|---|---|---|---|
| CBT/IST 64 |
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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.
Male and female subjects at least 18 years of age with moderate to severe plaque psoriasis treated with 12 weeks of alefacept 15 mg IM and who have not achieved the desired response.
Dosing Groups: Subjects will receive either 4, 8, or 12 doses of alefacept 15 mg IM weekly immediately (within 14 days) following a standard 12-dose course of AMEVIVE® 15 mg IM. Determination of number of doses will be based on physician qualitative assessment at weeks 4 and 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alefacept | Drug | IM |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of treating subjects with up to 12 additional doses of alefacept 15 mg IM following a standard 12-week course of AMEVIVE. | 16 weeks, 20 weeks or 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study, | End of study | |
| The cumulative change in PQA score from screening visit to best PQA score at any time in the study, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gold | GoldSkin Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monheit Dermatology Associates | Birmingham | Alabama | 35203 | United States | ||
| Bayshore Dermatology |
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| End of study |
| Association of the total number of doses received with the best efficacy reached, as assessed by PQA score, at any time during the study, | End of study |
| Time to re-treatment for subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study, | End of study |
| The cumulative change in SSA score from screening visit to best SSA score at any time in the study, | End of study |
| Association of the total number of doses received with the best efficacy reached, as assessed by SSA score, at any time during the study, and | End of study |
| Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively. | End of study |
| Fairhope |
| Alabama |
| 36532 |
| United States |
| Jayne Fortson | Anchorage | Alaska | 99501 | United States |
| Bakersfield Dermatology & Skin Cancer Medical Group | Bakersfield | California | 93301 | United States |
| Integrated Research Group | Riverside | California | 92501 | United States |
| Robert Greenberg | San Ramon | California | 94582 | United States |
| Front Dermatology | Denver | Colorado | 80014 | United States |
| Skin and Cancer Associates | Tamarac | Florida | 33309 | United States |
| Michael Scannon | Tampa | Florida | 33602 | United States |
| Atlanta Derm, Vein & Research Center | Alpharetta | Georgia | 30004 | United States |
| Pearlridge Dermatology | ‘Aiea | Hawaii | 96701 | United States |
| Altman Dermatology Associates | Arlington Heights | Illinois | 60004 | United States |
| Calumet Dermatology Associates | Calumet City | Illinois | 60477 | United States |
| Michael Greenberg | Elk Grove Village | Illinois | 60007 | United States |
| David J. Coynik | Peru | Illinois | 61354 | United States |
| Melissa Knuckles | Corbin | Kentucky | 40701 | United States |
| Richard Eisen | Plymouth | Massachusetts | 02360 | United States |
| Psoriasis Treatment Center | Grand Rapids | Michigan | 49503 | United States |
| Woodson Clinical Studies Group, Inc. | Las Vegas | Nevada | 89101 | United States |
| Nashua Dermatology | Nashua | New Hampshire | 03060 | United States |
| Jerry Bagel | East Windsor | New Jersey | 08512 | United States |
| Catskill Dermatology | Monticello | New York | 12701 | United States |
| Marina I Peredo | Smithtown | New York | 11787 | United States |
| Buffalo Medical Group | Williamsville | New York | 14221 | United States |
| Wilmington Health Associates Dermatology | Wilmington | North Carolina | 28401 | United States |
| Robert Brodell | Warren | Ohio | 44481 | United States |
| Dermatology & Laser Center of Roseberg | Roseburg | Oregon | 97470 | United States |
| Dermatology Assoc of Plymouth Meeting | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Dermatology Associates of Knoxville | Knoxville | Tennessee | 37902 | United States |
| Gold Skin Care | Nashville | Tennessee | 37201 | United States |
| Bellaire Dermatology Associates | Bellaire | Texas | 77401 | United States |
| Texas Dermatology Research | Dallas | Texas | 75201 | United States |
| Mark Wallis | Longview | Texas | 75601 | United States |
| Stephen Miller | San Antonio | Texas | 78201 | United States |
| Stephen Flax | Winchester | Virginia | 22601 | United States |
| Dermatology & Laser Center | Bellingham | Washington | 98225 | United States |
| 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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