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This is a Phase IV open-label study to evaluate the efficacy and safety of SC efalizumab in adult subjects (18 years of age and older) with chronic moderate or worse plaque psoriasis who have had an inadequate response to treatment with an anti-TNF agent. The study will consist of a screening period, a treatment period, and an observation period. All subjects will begin in the screening period (the length of which is dependent on the previous anti-TNF agent treatment). Approximately 100 eligible subjects will receive treatment from Day 0 through Day 168.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efalizumab | Drug | Subcutaneous repeating dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) | The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe | Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With a PGA Rating of Clear (0), Almost Clear (1), or Mild (2) | The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe | Day 168 |
| Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1) |
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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 | Title | Description |
|---|---|---|
| FG000 | Efalizumab | After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Efalizumab | After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) | The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe | Intent-to-treat (ITT) | Posted | Number | percentage | Day 84 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications Specialist | Genentech, Inc. | 800-821-8590 |
| 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 PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe |
| Day 84 |
| Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1) | The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe | Day 168 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Proportion of Subjects With a PGA Rating of Clear (0), Almost Clear (1), or Mild (2) | The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe | Intent-to-treat (ITT) | Posted | Number | percentage | Day 168 |
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| Secondary | Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1) | The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe | Intent-to-treat (ITT) | Posted | Number | percentage | Day 84 |
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| Secondary | Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1) | The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe | Intent-to-treat (ITT) | Posted | Number | percentage | Day 168 |
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