Psoriasis With Cell-derived MicroparticlesPhase 4NCT02693470
The Difference of Microparticles in Patients With Psoriasis Vulgaris Who Received Stelara(Ustekinumab)
A Phase 4 study testing Ustekinumab in people with Psoriasis With Cell-derived Microparticles, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis With Cell-derived Microparticles
- What is being tested?
- Ustekinumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2014to Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The psoriatic patients and healthy controls who have pregnancy or infection (such as tuberculosis or sepsis) are excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Dermatology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan
Kaohsiung, Taiwan, 833
Chih-Hung Lee, M.D., PhD, +886-7-7317123 ext. 2424, dermlee@gmail.com
About this study
Official title: The Difference of Circulating Endothelial-derived and Platelet-derived Microparticles in Patients With Psoriasis Successfully Treated With Stelara(Ustekinumab)
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.
Read the 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.
- Being tested
- Ustekinumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Also called Stelara
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 group | Role | What they receive |
|---|---|---|
| single-arm study | Other | 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. Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of CD41a and CD31 positive microparticles in patients with severe psoriasis before and after ustekinumab treatment.
Measured: The levels of CD41a and CD31 positive microparticles are checked in patients with psoriasis before and 4 months after ustekinumab.
Secondary outcomes (1)
The difference of CD41a and CD31 positive microparticles between normal control and patients with severe psoriasis
Measured: Patients with severe psoriasis: microparticles are checked at baseline. Control group: microparticles are checked at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startAug 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis With Cell-derived MicroparticlesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Hung Lee, M.D.PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693470
- Sponsor's protocol ID
- CGMH-0312A3
- Status last verified
- Feb 2016
- First submitted
- 15 Feb 2016
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference of Circulating Endothelial-derived and Platelet-derived Microparticles in Patients With Psoriasis Successfully Treated With Stelara(Ustekinumab)
- ClinicalTrials.gov ID
- NCT02693470
- Acronym / sponsor ID
- CGMH-0312A3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm study | Other | Drug: Ustekinumab50 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- The psoriatic patients and healthy controls who have pregnancy or infection (such as tuberculosis or sepsis) are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabAlso: Stelara50 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. | Drug | single-arm study |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Hung Lee, M.D.PhD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ustekinumab in people with Psoriasis With Cell-derived Microparticles, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shang-Hung Lin, M.D. (+886-7-7317123 ext. 2424, hongfufu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.