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

Psoriasis With Cell-derived Microparticles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02693470
• Other study ID #: CGMH-0312A3
• Status: Recruiting
• Phase: Phase 4
• First received: February 15, 2016
• Last updated: February 25, 2016
• Start date: August 2014
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Chang Gung Memorial Hospital
• Contact: Shang-Hung Lin, M.D.
• Phone: +886-7-7317123
• Email: hongfufu[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis With Cell-derived Microparticles

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department of Dermatology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No