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The Difference of Microparticles in Patients With Psoriasis Vulgaris Who Received Stelara(Ustekinumab)

  Purpose

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 Intervention Phase
Psoriasis With Cell-derived Microparticles Drug: Ustekinumab Phase 4

Study Type: Interventional
Study Design:Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title:The Difference of Circulating Endothelial-derived and Platelet-derived Microparticles in Patients With Psoriasis Successfully Treated With Stelara(Ustekinumab)

Resource links provided by NLM:

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:

  • 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. ]

Secondary Outcome Measures:

  • 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. ]

Estimated Enrollment:100
Study Start Date:August 2014
Estimated Study Completion Date:July 2016
Estimated Primary Completion Date:July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single-arm study

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.

Drug: Ustekinumab

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

Detailed Description:

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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