The Difference of Microparticles in Patients With Psoriasis Vulgaris Who Received Stelara(Ustekinumab)
Primary Purpose
Psoriasis With Cell-derived Microparticles
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Ustekinumab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis With Cell-derived Microparticles
Eligibility Criteria
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.
Sites / Locations
- Department of Dermatology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, TaiwanRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
single-arm study
Arm 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.
Outcomes
Primary Outcome Measures
The difference of CD41a and CD31 positive microparticles in patients with severe psoriasis before and after ustekinumab treatment.
Secondary Outcome Measures
The difference of CD41a and CD31 positive microparticles between normal control and patients with severe psoriasis
Full Information
NCT ID
NCT02693470
First Posted
February 15, 2016
Last Updated
February 25, 2016
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02693470
Brief Title
The Difference of Microparticles in Patients With Psoriasis Vulgaris Who Received Stelara(Ustekinumab)
Official Title
The Difference of Circulating Endothelial-derived and Platelet-derived Microparticles in Patients With Psoriasis Successfully Treated With Stelara(Ustekinumab)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis With Cell-derived Microparticles
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single-arm study
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Other Intervention Name(s)
Stelara
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shang-Hung Lin, M.D.
Phone
+886-7-7317123
Ext
2424
Email
hongfufu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Hung Lee, M.D.PhD
Phone
+886-7-7317123
Ext
2424
Email
dermlee@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Hung Lee, M.D.PhD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Dermatology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Hung Lee, M.D., PhD
Phone
+886-7-7317123
Ext
2424
Email
dermlee@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Difference of Microparticles in Patients With Psoriasis Vulgaris Who Received Stelara(Ustekinumab)
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