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

The Difference of Circulating Endothelial-derived and Platelet-derived Microparticles in Patients With Psoriasis Successfully Treated With Stelara(Ustekinumab)

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02693470
Enrollment
100
Registered
2016-02-26
Start date
2014-08-31
Completion date
2016-07-31
Last updated
2016-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis With Cell-derived Microparticles

Brief summary

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.

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.

Interventions

DRUGUstekinumab

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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with severe psoriasis who receive ustekinumab treatment. * Patients in the control group are examined thoroughly to make sure no psoriatic lesions by two dermatologists. Age, sex, lipid profiles, and blood pressure are recorded for all subjects.

Exclusion criteria

* The psoriatic patients and healthy controls who have pregnancy or infection (such as tuberculosis or sepsis) are excluded.

Design outcomes

Primary

MeasureTime 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.

Secondary

MeasureTime frame
The difference of CD41a and CD31 positive microparticles between normal control and patients with severe psoriasisPatients with severe psoriasis: microparticles are checked at baseline. Control group: microparticles are checked at baseline.

Countries

Taiwan

Contacts

Primary ContactShang-Hung Lin, M.D.
hongfufu@gmail.com+886-7-7317123
Backup ContactChih-Hung Lee, M.D.PhD
dermlee@gmail.com+886-7-7317123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026