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| ID | Type | Description | Link |
|---|---|---|---|
| Amgen Protocol 20060514 | Other Identifier | Amgen 20060514 |
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The purpose of this research study is to see how well (compared to placebo) Enbrel® (etanercept) 50 mg twice a week for 12 weeks affects plaque psoriasis of the hands and/or feet (palmoplantar psoriasis).
This multicenter investigation is a 12 week, double-blind, randomized trial of etanercept, 50 mg twice weekly versus placebo in subjects with palmoplantar psoriasis (PPP). Subjects who meet the eligibility criteria will be randomized to either 50 mg etanercept twice weekly or placebo. Subcutaneous injections will occur twice weekly at approximately the same time of day over the 12-week treatment period. The primary efficacy endpoint will be assessed after 12 weeks of treatment. At the end of the first 12 weeks, all patients (both treatment and placebo arms) will be treated with etanercept 50 mg twice a week (BIW) for an additional 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Etanercept (Enbrel) 50mg twice weekly injections for 12 weeks |
|
| Placebo Group | Placebo Comparator | Placebo Injections twice weekly for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Biological | Subcutaneous injections 50 mg Etanercept will occur twice weekly over a 12-week treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks. | Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index (PPPASI) is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4, with 4 being the most severe. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald D Weinstein, M.D. | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine Dermatology Clinical Research Center | Irvine | California | 92697 | United States | ||
| Wake Forest University School of Medicine |
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Subjects were recruited from the dermatology clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks | Subjects were randomized to receive etanercept 50mg twice weekly injection for 12 weeks. Subjects were then treated for another 12 weeks with etanercept 50 mg twice weekly. An additional follow-up visit performed on week 28. |
| FG001 | Subjects Receiving Placebo for 12 Weeks | Subjects randomized to receive placebo injection twice weekly for 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50 mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks | Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. |
| BG001 | Subjects Receiving Placebo for 12 Weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks. | Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index (PPPASI) is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4, with 4 being the most severe. | Intention to treat | Posted | Number | participants | Week 12 |
|
Adverse event data were collected over a 28 week period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks | Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Feldman, MD, PhD | Wake Forest Baptist Health, Department of Dermatology | 336-716-3775 | sfeldman@wakehealth.edu |
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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 |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Placebo injections | Other | Placebo injections twice weekly for 12 weeks. |
|
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| Dermatology Associates, PLLC | Seattle | Washington | 98101 | United States |
Subjects randomized to placebo injection twice weekly for 12 weeks.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Subjects Receiving Placebo for the First 12 Weeks |
Subjects randomized placebo injection for 12 weeks. |
|
|
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | Subjects Receiving Placebo for 12 Weeks | Subjects randomized placebo injection for 12 weeks. An additional follow-up visit was performed on week 28. | 0 | 12 | 4 | 12 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |