PsoriasisPhase 4NCT02144857
Effects of Treatment With Biological Agents on Vascular and Cardiac Function in Psoriasis
A Phase 4 study testing etanercept, ustekinumab and cyclosporine in people with Psoriasis, run by University of Athens at 1 site in Greece.
Trial summary
Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction and myocardial dysfunction are impaired in patients with psoriasis compared to normal controls ,coronary artery disease patients and… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- etanercept, ustekinumab and cyclosporine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 30 May 2014to 31 Dec 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with psoriasis
- Age and sex matched patients with CAD, with untreated hypertension and healthy subjects
Who cannot join
- for psoriasis patients were presence of wall motion abnormalities and ejection fraction ≤ 50%, psoriatic arthritis, history of acute coronary syndrome, familial hyperlipidemia, insulin dependent-diabetes mellitus, chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart disease, primary cardiomyopathies and malignant tumors. CAD was excluded in psoriasis patients by absence of clinical history, angina and reversible myocardial ischemia, as assessed by dobutamine stress echocardiography or thallium scintigraphy
- regarding the group of CAD patients, we only included patients without history of ST elevation myocardial infarction in order to exclude the presence of transmural scar compromising myocardial function indices. Thus, CAD patients with wall motion abnormalities and ejection fraction of ≤ 50% were excluded. In addition, exclusion criteria, were history of acute coronary syndrome without ST-segment elevation within the last year, familial hyperlipidemia, insulin dependent-diabetes mellitus, chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart disease, primary cardiomyopathies and malignant tumor
- in normal controls, CAD was excluded by the presence of normal ECG, absence of clinical history and absence of reversible ischemia by means of treadmill test or dobutamine stress echocardiography
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Attikon Hospital
Athens, 12462
Ignatios Ikonomidis, Dr, +302105832187, ignoik@gmail.com
Ignatios Ikonomidis, Dr
About this study
Official title: Effects of Treatment With Biological Agents on Endothelial Glycocalyx,Arterial Elastic Properties, Coronary Flow, Myocardial Deformation and Twisting in Psoriasis. Comparative Study With Patients With CAD or Untreated Hypertension.
Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction and myocardial dysfunction are impaired in patients with psoriasis compared to normal controls ,coronary artery disease patients and untreated hypertension subjects. The investigators also examined the effect of treatment with biological vs no biological agents on vascular and LV function in psoriasis.
Read the detailed description
The investigators will compare patients with psoriasis with age and sex matched normal controls as well as patients with angiographically documented CAD and patients with untreated hypertension (HYP) used as positive control groups
Patients with psoriasis (PS) will be randomized to receive an anti-tumor necrosis-a (TNF-a) ,an anti- interleukin 12/23 regimen, an interleukin 17A antagonist, apremilast (inhibitor of phosphodiesterase-4) or a cyclosporine regimen.
The anti-TNF-agent, Etanercept will be given at a dose 50mg twice weekly for 12 weeks and after then once weekly.
The anti-IL12/23 regimen, Ustekinumab will be given at a dose 45 mg at the first visit, at 4 weeks and every 12 weeks if body weight is up to 90 kgr. For body weight >90kgr dose will be adjusted accordingly.
The IL-17A antagonist regimen namely secukinumab 300 mg SC at weeks 0, 1, 2, 3, and 4 and 300 mg SC once monthly afterwards Apremilast will be given at a dose of 30mg orally twice daily Cyclosporine will be administered at a dose 2.5-3mg/kgr daily.
At baseline , after 12 weeks and one year of treatment, the investigators will measure:
- pulse wave velocity (PWVc) augmentation index (AI) central systolic blood pressure (cSBP) (Complior, Alam Medical and Arteriograph,TensioMed)
- flow-mediated dilation of the brachial artery (FMD)
- carotid intima-media thickness (IMT) by ultrasonography
- coronary flow reserve of the LAD (CFR) by Doppler echocardiography
- E'/A of mitral annular velocities ,LV longitudinal (GLS -%),strain, and strain rate (LongSr-l/s), peak twisting (Tw -deg),peak twisting (Tw-deg/sec)velocity,untwisting at mitral valve opening (unTw) and untwisting (unTw) velocity using speckle tracking echocardiography .
- Perfused boundary region (PBR)of the sublingual arterial microvessels (ranged from 5-25 microns) using Sideview Darkfield imaging. (Microscan, Glycocheck) .The PBR in microvessels is the cell-poor layer which results from the phase separation between the flowing red blood cells (RBC) and plasma.The PBR includes the most luminal part of glycocalyx that does allow cell penetration. Increased PBR is considered an accurate index of reduced endothelial glycocalyx thickness because of a deeper RBC penetration in the glycocalyx.
- Fetuin serum levels, markers of oxidative stress such as malondialdehyde (MDA) serum levels, protein carbonyls aw well as thrombosis and inflammation biomarkers
- Conditions
- Psoriasis
- Being tested
- etanercept, ustekinumab, cyclosporine, Secukinumab, Apremilast
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
Also called Enbrel
50 mg
ustekinumabDrug
Also called Stelara
45 mg
cyclosporineDrug
Also called Neoral
Cyclosporine 2.5-3 mg/kgr
SecukinumabDrug
Also called Cosentyx
300 mg
ApremilastDrug
Also called Otezla
30mg
| Study group | Role | What they receive |
|---|---|---|
| Anti-TNFa regimen | Active comparator | Etanercept 50 mg Receives: Drug: etanercept |
| Anti IL12/23 regimen | Active comparator | ustekinumab 45 mg Receives: Drug: ustekinumab |
| Cyclosporine regimen | Active comparator | Cyclosporine 2.5-3 mg/kg Receives: Drug: cyclosporine |
| anti-interleukin 17 A regimen | Active comparator | secukinumab 300 mg Receives: Drug: Secukinumab |
| inhibitor of phosphodiesterase-4 | Active comparator | apremilast 30mg Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis
Comparison of effect (improvement or deterioration) of treatment with biological agents (anti-tumor necrosis factor-a, anti-interleukin 12/23, anti-interleukin 17A, or apremilast regimen) with the effects of cyclosporine on endothelial function as assessed by flow mediated dilatation of the brachial artery, coronary flow reserve and endothelial glycocalyx thickness
Measured: 12 weeks
Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis
Comparison of effect (improvement or deterioration) of treatment with biological agents (anti-tumor necrosis factor-a, anti-interleukin 12/23, anti-interleukin 17A, or apremilast regimen) with the effects of cyclosporine on vascular function as assessed by pulse wave velocity, augmentation index and central aortic blood pressure,
Measured: 12 weeks
Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis
Comparison of effect (improvement or deterioration) of treatment with biological agents (anti-tumor necrosis factor-a, anti-interleukin 12/23 ,anti-interleukin 17A, or apremilast regimen) with the effects of cyclosporine on cardiac function as assessed by longitudinal myocardial deformation, twisting and untwisting of the left ventricle
Measured: 12 weeks
Secondary outcomes (4)
Differences and similarities in endothelial function between psoriasis and control groups
Differences in endothelial function between psoriasis and normal controls, and similarities in endothelial function between psoriasis and coronary artery disease patients and untreated hypertension patients before and after 4 week of anti-inflammatory treatment in patients with psoriasis .The following parameters will be compared among the study subgroups endothelial function as assessed by flow mediated dilatation of the brachial artery, coronary flow reserve and endothelial glycocalyx thickness
Measured: 0 and 12 weeks
Differences and similarities in vascular function between psoriasis and control groups
Differences in vascular function between psoriasis and normal controls, and similarities in vascular function between psoriasis and coronary artery disease patients and untreated hypertension patients before and after 4 week of anti-inflammatory treatment in patients with psoriasis .The following parameters will be compared among the study subgroups vascular function as assessed by pulse wave velocity, augmentation index and central aortic blood pressure,
Measured: 0 and 12 weeks
Differences and similarities in cardiac function between psoriasis and control groups
Differences in cardiac function between psoriasis and normal controls, and similarities in cardiac function between psoriasis and coronary artery disease patients and untreated hypertension patients before and after 4 week of anti-inflammatory treatment in patients with psoriasis The following parameters will be compared among the study subgroups cardiac function as assessed by longitudinal myocardial deformation, twisting and untwisting of the left ventricle
Measured: 0 and 12 weeks
Effects of anti-inflammatory treatment on prognosis for major adverse cardiovascular events
Effects of anti-inflammatory treatment on myocardial infarction, stroke, hospitalization because of heart failure, and cardiovascular death
Measured: 4-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study start30 May 2014
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
- Investigators
- Ignatios Ikonomidis, Dr, Principal investigator, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144857
- Sponsor's protocol ID
- 213/19-6-12
- Status last verified
- May 2023
- First submitted
- 12 May 2014
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Ikonomidis I, Pavlidis G, Lambadiari V, Rafouli-Stergiou P, Makavos G, Thymis J, Kostelli G, Varoudi M, Katogiannis K, Theodoropoulos K, Katsimbri P, Parissis J, Papadavid E. Endothelial glycocalyx and microvascular perfusion are associated with carotid intima-media thickness and impaired myocardial deformation in psoriatic disease. J Hum Hypertens. 2022 Dec;36(12):1113-1120. doi: 10.1038/s41371-021-00640-2. Epub 2021 Nov 25.
PubMed 34819613Ikonomidis I, Papadavid E, Makavos G, Andreadou I, Varoudi M, Gravanis K, Theodoropoulos K, Pavlidis G, Triantafyllidi H, Moutsatsou P, Panagiotou C, Parissis J, Iliodromitis E, Lekakis J, Rigopoulos D. Lowering Interleukin-12 Activity Improves Myocardial and Vascular Function Compared With Tumor Necrosis Factor-a Antagonism or Cyclosporine in Psoriasis. Circ Cardiovasc Imaging. 2017 Sep;10(9):e006283. doi: 10.1161/CIRCIMAGING.117.006283.
PubMed 28899951
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treatment With Biological Agents on Endothelial Glycocalyx,Arterial Elastic Properties, Coronary Flow, Myocardial Deformation and Twisting in Psoriasis. Comparative Study With Patients With CAD or Untreated Hypertension.
- ClinicalTrials.gov ID
- NCT02144857
- Acronym / sponsor ID
- 213/19-6-12
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 30 May 2014 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 May 2014 (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.
Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction and myocardial dysfunction are impaired in patients with psoriasis compared to normal controls ,coronary artery disease patients and untreated hypertension subjects. The investigators also examined the effect of treatment with biological vs no biological agents on vascular and LV function in psoriasis.
Detailed description
The investigators will compare patients with psoriasis with age and sex matched normal controls as well as patients with angiographically documented CAD and patients with untreated hypertension (HYP) used as positive control groups
Patients with psoriasis (PS) will be randomized to receive an anti-tumor necrosis-a (TNF-a) ,an anti- interleukin 12/23 regimen, an interleukin 17A antagonist, apremilast (inhibitor of phosphodiesterase-4) or a cyclosporine regimen.
The anti-TNF-agent, Etanercept will be given at a dose 50mg twice weekly for 12 weeks and after then once weekly.
The anti-IL12/23 regimen, Ustekinumab will be given at a dose 45 mg at the first visit, at 4 weeks and every 12 weeks if body weight is up to 90 kgr. For body weight >90kgr dose will be adjusted accordingly.
The IL-17A antagonist regimen namely secukinumab 300 mg SC at weeks 0, 1, 2, 3, and 4 and 300 mg SC once monthly afterwards Apremilast will be given at a dose of 30mg orally twice daily Cyclosporine will be administered at a dose 2.5-3mg/kgr daily.
At baseline , after 12 weeks and one year of treatment, the investigators will measure:
- pulse wave velocity (PWVc) augmentation index (AI) central systolic blood pressure (cSBP) (Complior, Alam Medical and Arteriograph,TensioMed)
- flow-mediated dilation of the brachial artery (FMD)
- carotid intima-media thickness (IMT) by ultrasonography
- coronary flow reserve of the LAD (CFR) by Doppler echocardiography
- E'/A of mitral annular velocities ,LV longitudinal (GLS -%),strain, and strain rate (LongSr-l/s), peak twisting (Tw -deg),peak twisting (Tw-deg/sec)velocity,untwisting at mitral valve opening (unTw) and untwisting (unTw) velocity using speckle tracking echocardiography .
- Perfused boundary region (PBR)of the sublingual arterial microvessels (ranged from 5-25 microns) using Sideview Darkfield imaging. (Microscan, Glycocheck) .The PBR in microvessels is the cell-poor layer which results from the phase separation between the flowing red blood cells (RBC) and plasma.The PBR includes the most luminal part of glycocalyx that does allow cell penetration. Increased PBR is considered an accurate index of reduced endothelial glycocalyx thickness because of a deeper RBC penetration in the glycocalyx.
- Fetuin serum levels, markers of oxidative stress such as malondialdehyde (MDA) serum levels, protein carbonyls aw well as thrombosis and inflammation biomarkers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Anti-TNFa regimen | Active comparator | Drug: etanerceptEtanercept 50 mg |
| Anti IL12/23 regimen | Active comparator | Drug: ustekinumabustekinumab 45 mg |
| Cyclosporine regimen | Active comparator | Drug: cyclosporineCyclosporine 2.5-3 mg/kg |
| anti-interleukin 17 A regimen | Active comparator | Drug: Secukinumabsecukinumab 300 mg |
| inhibitor of phosphodiesterase-4 | Active comparator | Drug: Apremilastapremilast 30mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with psoriasis
- Age and sex matched patients with CAD, with untreated hypertension and healthy subjects
Key exclusion criteria (3 listed)
- for psoriasis patients were presence of wall motion abnormalities and ejection fraction ≤ 50%, psoriatic arthritis, history of acute coronary syndrome, familial hyperlipidemia, insulin dependent-diabetes mellitus, chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart disease, primary cardiomyopathies and malignant tumors. CAD was excluded in psoriasis patients by absence of clinical history, angina and reversible myocardial ischemia, as assessed by dobutamine stress echocardiography or thallium scintigraphy
- regarding the group of CAD patients, we only included patients without history of ST elevation myocardial infarction in order to exclude the presence of transmural scar compromising myocardial function indices. Thus, CAD patients with wall motion abnormalities and ejection fraction of ≤ 50% were excluded. In addition, exclusion criteria, were history of acute coronary syndrome without ST-segment elevation within the last year, familial hyperlipidemia, insulin dependent-diabetes mellitus, chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart disease, primary cardiomyopathies and malignant tumor
- in normal controls, CAD was excluded by the presence of normal ECG, absence of clinical history and absence of reversible ischemia by means of treadmill test or dobutamine stress echocardiography
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 |
|---|---|---|
| etanerceptAlso: Enbrel50 mg | Drug | Anti-TNFa regimen |
| ustekinumabAlso: Stelara45 mg | Drug | Anti IL12/23 regimen |
| cyclosporineAlso: NeoralCyclosporine 2.5-3 mg/kgr | Drug | Cyclosporine regimen |
| SecukinumabAlso: Cosentyx300 mg | Drug | anti-interleukin 17 A regimen |
| ApremilastAlso: Otezla30mg | Drug | inhibitor of phosphodiesterase-4 |
Primary outcome
Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis
Time frame: 12 weeks
Comparison of effect (improvement or deterioration) of treatment with biological agents (anti-tumor necrosis factor-a, anti-interleukin 12/23, anti-interleukin 17A, or apremilast regimen) with the effects of cyclosporine on endothelial function as assessed by flow mediated dilatation of the brachial artery, coronary flow reserve and endothelial glycocalyx thickness
Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis
Time frame: 12 weeks
Comparison of effect (improvement or deterioration) of treatment with biological agents (anti-tumor necrosis factor-a, anti-interleukin 12/23, anti-interleukin 17A, or apremilast regimen) with the effects of cyclosporine on vascular function as assessed by pulse wave velocity, augmentation index and central aortic blood pressure,
Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis
Time frame: 12 weeks
Comparison of effect (improvement or deterioration) of treatment with biological agents (anti-tumor necrosis factor-a, anti-interleukin 12/23 ,anti-interleukin 17A, or apremilast regimen) with the effects of cyclosporine on cardiac function as assessed by longitudinal myocardial deformation, twisting and untwisting of the left ventricle
4 secondary outcomes
Differences and similarities in endothelial function between psoriasis and control groups
Time frame: 0 and 12 weeks
Differences and similarities in vascular function between psoriasis and control groups
Time frame: 0 and 12 weeks
Differences and similarities in cardiac function between psoriasis and control groups
Time frame: 0 and 12 weeks
Effects of anti-inflammatory treatment on prognosis for major adverse cardiovascular events
Time frame: 4-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 34819613Ikonomidis I, Pavlidis G, Lambadiari V, Rafouli-Stergiou P, Makavos G, Thymis J, Kostelli G, Varoudi M, Katogiannis K, Theodoropoulos K, Katsimbri P, Parissis J, Papadavid E. Endothelial glycocalyx and microvascular perfusion are associated with carotid intima-media thickness and impaired myocardial deformation in psoriatic disease. J Hum Hypertens. 2022 Dec;36(12):1113-1120. doi: 10.1038/s41371-021-00640-2. Epub 2021 Nov 25.
- Derived from this study: PubMed 28899951Ikonomidis I, Papadavid E, Makavos G, Andreadou I, Varoudi M, Gravanis K, Theodoropoulos K, Pavlidis G, Triantafyllidi H, Moutsatsou P, Panagiotou C, Parissis J, Iliodromitis E, Lekakis J, Rigopoulos D. Lowering Interleukin-12 Activity Improves Myocardial and Vascular Function Compared With Tumor Necrosis Factor-a Antagonism or Cyclosporine in Psoriasis. Circ Cardiovasc Imaging. 2017 Sep;10(9):e006283. doi: 10.1161/CIRCIMAGING.117.006283.
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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.
Ignatios Ikonomidis, Dr principal investigator
University of Athens
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 etanercept, ustekinumab and cyclosporine in people with Psoriasis, run by University of Athens at 1 site in Greece.
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 3 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 16 May 2023. 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 Greece. 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 Ignatios Ikonomidis, Dr (2105831264, ignoik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02144857, which also lists 2 linked publications.
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 16 May 2023.