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This is a Phase IV randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of SC efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis involving the hands and/or feet who have had no previous exposure to efalizumab. The study will consist of a screening period, a treatment period, and an observation period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efalizumab | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy outcome measure is the proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 84. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 42 | ||
| The proportion of patients who achieve a PGA rating of clear (0) or almost clear (1) at Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivor Caro, M.D. | Genentech, Inc. | Study Director |
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| 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 |
|---|---|
| C472181 | efalizumab |
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| The change from Day 0 to Day 84 in the following PRO measures: SF 36, PDS, Work Loss Questionnaire |
| The change from Day 0 in PGA rating (i.e., the number of categories changed) at Day 84 |