An observational study in Rheumatoid Arthritis and Inflammation, sponsored by University of Athens. Status unknown at 1 site in Greece. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-03.
Sponsored by University of Athens · Observational
Recent studies show beneficial effect of the inhibition of interleukin-6 (IL-6) activity on vascular and left ventricular (LV) function. The purpose of this study is to investigate whether anakinra, an IL-6 receptor antagonist, improves vascular, endothelial and LV function in patients with rheumatoid arthritis (RA).
The inflammatory processes observed in patients with rheumatoid arthritis (RA) are strongly linked to enhanced interleukin-6 (IL-6) activity. Increased IL-6 activity causes myocardial cell damage and endothelial dysfunction. The adverse effects of IL-6 on myocardial and endothelial cells are mediated by an enhanced nitrooxidative stress and the promotion of apoptotic cardiomyocyte death through increased nitrooxidative stress and inflammation. Tocilizumab, a recombinant form of human IL-6 receptor antagonist, is commonly used for the treatment of RA. However it has not been defined whether inhibition of IL-6 activity by tocilizumab shows beneficial effects on endothelial, coronary, arterial and LV systolic and diastolic function in patients with RA.
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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 60 is below the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →University of Athens is the lead sponsor of 139 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with rheumatoid arthritis who had an inadequate response to disease modifying antirheumatic drugs (DMARDs) and corticosteroids and were going to initiate treatment with interleukin-6 inhibitor.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inhibition of Interleukin-6 activity by tocilizumab (Actemra®) 150mg od, sc injection
Drug: Tocilizumab (Actemra®)
Other biological agent (TNFa inhibitor, abatacept, rituximab, IL-1Ra)
Drug: Other biological agent
Enhanced treatment with corticosteroid and non-biological agents.
Drug: Corticosteroid and non-biological agents.
Inhibition of Interleukin-6 activity by tocilizumab (Actemra®) 150mg od, sc injection
Other biological agent (TNFa inhibitor, abatacept, rituximab, IL-1Ra)
Enhanced treatment with corticosteroid and non-biological agents.
Reduction of pulse wave velocity after treatment with tocilizumab
Reduction of pulse wave velocity (PWV, m/sec) using tonometry after administration of tocilizumab
Time frame: 3 months after treatment
Increase of global longitudinal strain after treatment with tocilizumab
Increase of left ventricular global longitudinal strain (GLS, %) using speckle tracking echocardiography after administration of tocilizumab
Time frame: 3 months after treatment
Reduction of malondialdehyde after treatment with tocilizumab
Reduction of malondialdehyde (MDA, nmol/L) using spectrophotometry after treatment with tocilizumab
Time frame: 3 months after treatment
Reduction of protein carbonyls after treatment with tocilizumab
Reduction of protein carbonyls (PCs, nmol/mg protein) using spectrophotometry after treatment with tocilizumab
Time frame: 3 months after treatment
Increased of endothelial glycocalyx thickness after treatment with tocilizumab
Increased of endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels after treatment with tocilizumab
Time frame: 3 months after treatment
Plan to share: No
Started Oct 2017 (actual). Primary completion is estimated for Dec 2020, 38 months after the start.
Of 234 non-industry observational studies under Arthritis, Rheumatoid, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 145. This study's planned 38 months is below that.
Counting every sponsor, half of 389 studies reached it within 50 months; a quarter within 25 and three quarters within 113.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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