The Difference of Microparticles in Patients With Psoriasis Vulgaris Who Received Stelara(Ustekinumab)
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|ClinicalTrials.gov Identifier: NCT02693470|
Recruitment Status : Unknown
Verified February 2016 by Chang Gung Memorial Hospital.
Recruitment status was: Recruiting
First Posted : February 26, 2016
Last Update Posted : February 26, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis With Cell-derived Microparticles||Drug: Ustekinumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Difference of Circulating Endothelial-derived and Platelet-derived Microparticles in Patients With Psoriasis Successfully Treated With Stelara(Ustekinumab)|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
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.
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.
Other Name: Stelara
- The difference of CD41a and CD31 positive microparticles in patients with severe psoriasis before and after ustekinumab treatment. [ Time Frame: The levels of CD41a and CD31 positive microparticles are checked in patients with psoriasis before and 4 months after ustekinumab. ]
- The difference of CD41a and CD31 positive microparticles between normal control and patients with severe psoriasis [ Time Frame: Patients with severe psoriasis: microparticles are checked at baseline. Control group: microparticles are checked at baseline. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693470
|Contact: Shang-Hung Lin, M.D.||+886-7-7317123 ext email@example.com|
|Contact: Chih-Hung Lee, M.D.PhD||+886-7-7317123 ext firstname.lastname@example.org|
|Department of Dermatology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan||Recruiting|
|Kaohsiung, Taiwan, 833|
|Contact: Chih-Hung Lee, M.D., PhD +886-7-7317123 ext 2424 email@example.com|
|Study Director:||Chih-Hung Lee, M.D.PhD||Chang Gung Memorial Hospital|