Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02693470
Recruitment Status : Unknown
Verified February 2016 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : February 26, 2016
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Psoriasis With Cell-derived Microparticles Drug: Ustekinumab Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Difference of Circulating Endothelial-derived and Platelet-derived Microparticles in Patients With Psoriasis Successfully Treated With Stelara(Ustekinumab)
Study Start Date : August 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ustekinumab

Arm Intervention/treatment
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.

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.
Other Name: Stelara




Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693470


Contacts
Layout table for location contacts
Contact: Shang-Hung Lin, M.D. +886-7-7317123 ext 2424 hongfufu@gmail.com
Contact: Chih-Hung Lee, M.D.PhD +886-7-7317123 ext 2424 dermlee@gmail.com

Locations
Layout table for location information
Taiwan
Department of Dermatology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan Recruiting
Kaohsiung, Taiwan, 833
Contact: Chih-Hung Lee, M.D., PhD    +886-7-7317123 ext 2424    dermlee@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Layout table for investigator information
Study Director: Chih-Hung Lee, M.D.PhD Chang Gung Memorial Hospital

Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02693470     History of Changes
Other Study ID Numbers: CGMH-0312A3
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Dermatologic Agents