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

Phase 4

• Conditions: Psoriasis With Cell-derived Microparticles
• Interventions: Drug: Ustekinumab

• Registration Number: NCT02693470
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2014-08
• Status Verified: 2016-02
• Study First Submitted: 2016-02-15
• Study First Submitted QC: 2016-02-25
• Last Update Submitted: 2016-02-25
• Study First Posted: 2016-02-26
• Last Update Posted: 2016-02-26
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single-arm study	Ustekinumab	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Dermatology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan; 🇨🇳 Kaohsiung, Taiwan