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

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Chang Gung Medical Foundation

Status and phase

Unknown
Phase 4

Conditions

Psoriasis With Cell-derived Microparticles

Treatments

Drug: Ustekinumab

Study type

Interventional

Funder types

Other

Identifiers

NCT02693470
CGMH-0312A3

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

single-arm study
Other group
Description:
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.
Treatment:
Drug: Ustekinumab

Trial contacts and locations

1

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Central trial contact

Shang-Hung Lin, M.D.; Chih-Hung Lee, M.D.PhD

Data sourced from clinicaltrials.gov

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