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

Sponsor
Chang Gung Memorial Hospital
Study ID
NCT02693470
Phase
PHASE4
Status
Unknown

Conditions

  • Psoriasis With Cell-derived Microparticles

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Ustekinumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2014
Status verified
Feb 2016
Primary completion
Jul 31, 2016
Completion
Jul 31, 2016

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: single-arm study
    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 Measure

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. ]

Central Contacts