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| Name | Class |
|---|---|
| Centocor, Inc. | INDUSTRY |
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The purpose of this study is to determine the short and long term safety and effectiveness of ustekinumab in subjects with moderate to severe chronic palmar plantar psoriasis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab | Drug | Dosing will consist of a 45mg subcutaneous injection for patients weighing less than 100 kg and a 90 mg subcutaneous injection for patients whose weight is greater than 100 kg. Dosing will begin on week 0 followed by subsequent dosing on week 4 and week 16. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PGA Score Over Time From Baseline to Week 24 | Measurement of subject's palmar and plantar psoriasis severity as measured by the Physician's Global Assessment (PGA) scale, which rates the severity of psoriasis using the measures of erythema, scaling and induration. Scores are from 0 to 4, in 1 unit increments. A score of 4 is very severe, and a score of 0 is clear. | Baseline, 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alice B Gottlieb, MD, PhD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
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Washout of 2 weeks for topicals, 4 weeks for all other biologics and systemics prior to baseline dosage.
Recruitment from Apr 2010 to Sept 2011 in the dermatology clinic of a tertiary care hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Main | All participants were treated the same |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screen |
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| ||||||||||||||||||
| Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Main |
| 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 | Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16. | Number of participants completing enrollment. Lost values carried forward as last observation carried forward | Posted | Number | percentage of participants | 16 weeks |
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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 | Main | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Mild Self-Limited Upper Respiratory Infection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alice Gottlieb | Tufts Medical Center | 617-636-7462 | Agottlieb@tuftsmedicalcenter.org |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Pustule Count (if Present at Baseline) From Baseline to Week 24 | Number of pustules present in each subject | Baseline, 24 weeks |
| Fissure Count (if Present at Baseline) From Baseline to Week 24 | Number of discrete fissures on the hands and feet of each subject. | Baseline, 24 weeks |
| Pruritus Visual Analog Scale From Baseline to Week 24 | Patient's score on the questionnaire of "how itchy are you", as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome). | Baseline, 24 weeks |
| Pain Visual Analog Scale From Baseline to Week 24 | Patient's score on the questionnaire of "how much pain are you experiencing from your disease of your hands and feet", as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. Visual Analog Scale (VAS). 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome). | Baseline, 24 weeks |
| Safety Outcome Measures | All adverse events (AE's) will be recorded and monitored. At each of the study visits, patients will be questioned about the occurrence of new AE's since the last visit, or the outcome of any AE's that were reported at previous visits. Upon study completion of the first 10 subjects the principal investigator will review all adverse events to check for trends. | 24 weeks |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | PGA Score Over Time From Baseline to Week 24 | Measurement of subject's palmar and plantar psoriasis severity as measured by the Physician's Global Assessment (PGA) scale, which rates the severity of psoriasis using the measures of erythema, scaling and induration. Scores are from 0 to 4, in 1 unit increments. A score of 4 is very severe, and a score of 0 is clear. | All participants who enrolled. Early terminations were carried as last observation carried forward. | Posted | Median | Full Range | units on a scale | Baseline, 24 weeks |
|
|
|
| Secondary | Pustule Count (if Present at Baseline) From Baseline to Week 24 | Number of pustules present in each subject | All participants who enrolled. Early terminations were carried as last observation carried forward. | Posted | Mean | Standard Deviation | pustules | Baseline, 24 weeks |
|
|
|
| Secondary | Fissure Count (if Present at Baseline) From Baseline to Week 24 | Number of discrete fissures on the hands and feet of each subject. | All participants who enrolled. Early terminations were carried as last observation carried forward. | Posted | Mean | Standard Deviation | fissures | Baseline, 24 weeks |
|
|
|
| Secondary | Pruritus Visual Analog Scale From Baseline to Week 24 | Patient's score on the questionnaire of "how itchy are you", as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome). | All participants who enrolled. Early terminations were carried as last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 24 weeks |
|
|
|
| Secondary | Pain Visual Analog Scale From Baseline to Week 24 | Patient's score on the questionnaire of "how much pain are you experiencing from your disease of your hands and feet", as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. Visual Analog Scale (VAS). 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome). | All participants who enrolled. Early terminations were carried as last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 24 weeks |
|
|
|
| Secondary | Safety Outcome Measures | All adverse events (AE's) will be recorded and monitored. At each of the study visits, patients will be questioned about the occurrence of new AE's since the last visit, or the outcome of any AE's that were reported at previous visits. Upon study completion of the first 10 subjects the principal investigator will review all adverse events to check for trends. | All participants who enrolled. Participants terminating prior to week 24 had their data carried forward as lost to follow-up. | Posted | Number | participants | 24 weeks |
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|
|
| 24 |
| 6 |
| 24 |
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| Acneiform Eruption | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild Acneiform Eruption, Self Limited |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |