Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis
NCT ID: NCT03288584
Last Updated: 2020-04-03
Study Results
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Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2017-10-27
2020-12-31
Brief Summary
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Detailed Description
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For this purpose, we studied 60 patients with RA (American Rheumatism Association criteria). All the above subjects had an inadequate response to disease modifying antirheumatic drugs (DMARDs) and corticosteroids and were going to initiate treatment with IL-6 activity inhibitor (tocilizumab). All patients were on treatment with statins and cardioactive medications respectively, for the last 6 months.
All patients were randomized to receive a single injection of tocilizumab (150 mg s.c.), or other biological agent (TNFa inhibitor, abatacept, rituximab, IL-1Ra) or enhanced treatment with corticosteroid and non-biological agents.
Twenty asymptomatic subjects matched for age and sex as the RA patients and with a normal ECG, echocardiogram, and treadmill test were selected as healthy control subjects among subjects attending the cardiology outpatients' clinic.
At baseline in all RA subjects and controls as well as 3 months after the single injection of tocilizumab in RA subjects, we assessed the following parameters a)carotid-femoral pulse wave velocity (PWV), b) the LV dimensions,fractional shortening and wall motion score index (WMSI) c) the systolic (Sm), early diastolic (Em) and late diastolic (Am) myocardial velocities of the mitral annulus by using of tissue Doppler (TDI) as well as the ratio of E wave of the mitral inflow measured by pulsed wave Doppler to the mean Em as an index of LV diastolic filling pressures d) the LV longitudinal, circumferential and radial strain and strain rate, as well as Global Longitudinal strain and Torsion using speckle tracking echocardiography e) the coronary flow reserve (CFR)after adenosine infusion to assess coronary vasomotor function f) the flow-mediated endothelial-dependent dilation of the brachial artery (FMD) to assess peripheral endothelial function g) the diameters of aorta at systole and diastole to calculate the aortic strain as an index of local aortic properties, h) perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5-25μm) using Sideview, Darkfield imaging (Microscan, Glycocheck). Increased PBR is considered an accurate index of reduced endothelial glucocalyx thickness because of a deeper red blood cells (RBC) penetration in the glucocalyx. At the same time periods, we measured in blood samples a) nitrotyrosine (NT), protein carbonyls (PC) and malondialdehyde (MDA) to assess oxidative stress, b) soluble Fas and Fas-ligand to assess apoptosis, and c) interleukin-6 and tumor necrosis factor-a to assess inflammation.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Tocilizumab
Inhibition of Interleukin-6 activity by tocilizumab (Actemra®) 150mg od, sc injection
Tocilizumab (Actemra®)
Inhibition of Interleukin-6 activity by tocilizumab (Actemra®) 150mg od, sc injection
Other biological agent
Other biological agent (TNFa inhibitor, abatacept, rituximab, IL-1Ra)
Other biological agent
Other biological agent (TNFa inhibitor, abatacept, rituximab, IL-1Ra)
Corticosteroid and non-biological agents.
Enhanced treatment with corticosteroid and non-biological agents.
Corticosteroid and non-biological agents.
Enhanced treatment with corticosteroid and non-biological agents.
Interventions
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Tocilizumab (Actemra®)
Inhibition of Interleukin-6 activity by tocilizumab (Actemra®) 150mg od, sc injection
Other biological agent
Other biological agent (TNFa inhibitor, abatacept, rituximab, IL-1Ra)
Corticosteroid and non-biological agents.
Enhanced treatment with corticosteroid and non-biological agents.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Diabetes mellitus
* Chronic obstructive pulmonary disease or asthma
* Moderate or severe valvular heart disease
* Primary cardiomyopathies
* Malignant tumors
18 Years
80 Years
ALL
Yes
Sponsors
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University of Athens
OTHER
Responsible Party
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Ignatios Ikonomidis
Associate Professor of Cardiology
Principal Investigators
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Ignatios Ikonomidis, MD
Role: PRINCIPAL_INVESTIGATOR
National and Kapodistrain University of Athens
Locations
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Attikon Hospital
Athens, Haidari, Greece
Countries
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Central Contacts
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Facility Contacts
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References
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Ikonomidis I, Pavlidis G, Katsimbri P, Lambadiari V, Parissis J, Andreadou I, Tsoumani M, Boumpas D, Kouretas D, Iliodromitis E. Tocilizumab improves oxidative stress and endothelial glycocalyx: A mechanism that may explain the effects of biological treatment on COVID-19. Food Chem Toxicol. 2020 Nov;145:111694. doi: 10.1016/j.fct.2020.111694. Epub 2020 Aug 18.
Ikonomidis I, Pavlidis G, Katsimbri P, Andreadou I, Triantafyllidi H, Tsoumani M, Varoudi M, Vlastos D, Makavos G, Kostelli G, Betaenas D, Lekakis J, Parissis J, Boumpas D, Alexopoulos D, Iliodromitis E. Differential effects of inhibition of interleukin 1 and 6 on myocardial, coronary and vascular function. Clin Res Cardiol. 2019 Oct;108(10):1093-1101. doi: 10.1007/s00392-019-01443-9. Epub 2019 Mar 11.
Other Identifiers
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RA-IL6-ATTIKON
Identifier Type: -
Identifier Source: org_study_id
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