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Background: Psoriasis, a common inflammatory disease, is associated with atherosclerotic vascular diseases, including stroke, myocardial infarction, and impaired microcirculations, among which circulating microparticles play an important role. In severe psoriasis, there are increased endothelial- and platelet- microparticles that are reduced by TNF-α blockers in parallel with clinical improvement. However, whether Stelara(ustekinumab) treatment would decrease the level of microparticles remains unknown.
Objective: The investigators will evaluate the level of microparticles among normal control, severe psoriasis before and 4 months after ustekinumab treatment.
Methods: The investigators will recruit 50 patients with severe psoriasis who received ustekinumab and 50 control subjects without psoriasis from August 2014 to July 2016. Concentrations of microparticles with expression for surface markers (Annexin V, CD31, and CD41a) will be measured in peripheral blood using flow cytometry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-arm study | Other | 50 patients with severe psoriasis who received Stelara(ustekinumab) at 0 and 1 month. The investigators check microparticles level at baseline and 4 months later. 50 patients without psoriasis: the microparticles are checked at baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab | Drug | 50 patients with severe psoriasis received ustekinumab 45mg at 0 and 1 month. There were 50 healthy controls. The levels of circulating CD31 and CD41a positive microparticles are measured. In patients with psoriasis, the investigators measure microparticles in the baseline and 4 months after ustekinumab. For control group, the investigators measure microparticles in the baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| The difference of CD41a and CD31 positive microparticles in patients with severe psoriasis before and after ustekinumab treatment. | The levels of CD41a and CD31 positive microparticles are checked in patients with psoriasis before and 4 months after ustekinumab. |
| Measure | Description | Time Frame |
|---|---|---|
| The difference of CD41a and CD31 positive microparticles between normal control and patients with severe psoriasis | Patients with severe psoriasis: microparticles are checked at baseline. Control group: microparticles are checked at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shang-Hung Lin, M.D. | Contact | +886-7-7317123 | 2424 | hongfufu@gmail.com |
| Chih-Hung Lee, M.D.PhD | Contact | +886-7-7317123 | 2424 | dermlee@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chih-Hung Lee, M.D.PhD | Chang Gung Memorial Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan | Recruiting | Kaohsiung | Taiwan | 833 | Taiwan |
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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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|
|
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |