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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown.
In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab 40mg | Experimental | Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] Dose administered every other week for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] | Drug | 40mg subcutaneously, every other week for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Endothelial Function Compared to Baseline. | Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in IL-6 Profile Compared to Baseline | IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months. | 6 months |
| Changes in Adiponectin Profile Compared to Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aida Lugo-Somolinos, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Dermatology Clinical Trials Unit | Chapel Hill | North Carolina | 27516 | United States |
no plan to share data
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | active Adalimumab: 40mg subcutaneously, every other week for 6 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | active Adalimumab: 40mg subcutaneously, every other week for 6 months |
| 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 Change in Endothelial Function Compared to Baseline. | Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%). | 17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed. | Posted | Mean | 95% Confidence Interval | percent change | 6 months |
|
Duration of study- 6 months
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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 | Adalimumab | active Adalimumab: 40mg subcutaneously, every other week for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| allergic drug reaction | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
Smaller number of subjects analyzed due to low enrollment. Technical problems with Elisa measurement leading to unreliable or uninterpretable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aida Lugo-Somolinos MD | University of North Carolina | 919-843-9447 | alugosom@med.unc.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 |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.
| 24 weeks |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Changes in IL-6 Profile Compared to Baseline | IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months. | 17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed. | Posted | Mean | 95% Confidence Interval | pg/ml | 6 months |
|
|
|
|
| Secondary | Changes in Adiponectin Profile Compared to Baseline | Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months. | 17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed. | Posted | Mean | 95% Confidence Interval | pg/ml | 24 weeks |
|
|
|
|
| 1 |
| 18 |
| 5 |
| 18 |
| heartburn | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| elbow strain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |