Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis

NCT03288584 | Unknown DMC

• 1 other identifier: RA-IL6-ATTIKON
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Rheumatoid Arthritis; Inflammation

Keywords

Arterial stiffness; Endothelial function; Endothelial glycocalyx; Left ventricular function; Apoptosis; Oxidative stress

Outcome Measures

Primary Outcomes (2)

• Reduction of pulse wave velocity after treatment with tocilizumab

  Reduction of pulse wave velocity (PWV, m/sec) using tonometry after administration of tocilizumab

  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

  3 months after treatment

Secondary Outcomes (3)

• Reduction of malondialdehyde after treatment with tocilizumab

  3 months after treatment

• Reduction of protein carbonyls after treatment with tocilizumab

  3 months after treatment

• Increased of endothelial glycocalyx thickness after treatment with tocilizumab

  3 months after treatment

Study Arms (3)

Tocilizumab

Inhibition of Interleukin-6 activity by tocilizumab (Actemra®) 150mg od, sc injection

Drug: Tocilizumab (Actemra®)

Other biological agent

Other biological agent (TNFa inhibitor, abatacept, rituximab, IL-1Ra)

Drug: Other biological agent

Corticosteroid and non-biological agents.

Enhanced treatment with corticosteroid and non-biological agents.

Drug: Corticosteroid and non-biological agents.

Interventions

Tocilizumab (Actemra®) DRUG

Inhibition of Interleukin-6 activity by tocilizumab (Actemra®) 150mg od, sc injection

Tocilizumab

Other biological agent DRUG

Other biological agent (TNFa inhibitor, abatacept, rituximab, IL-1Ra)

Other biological agent

Corticosteroid and non-biological agents. DRUG

Enhanced treatment with corticosteroid and non-biological agents.

Corticosteroid and non-biological agents.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Familiar hyperlipidemia
• Diabetes mellitus
• Chronic obstructive pulmonary disease or asthma
• Moderate or severe valvular heart disease
• Primary cardiomyopathies
• Malignant tumors

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Attikon Hospital

Athens, Haidari, 12462, Greece

RECRUITING

Related Publications (2)

• 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.

  PMID: 32822775 DERIVED

• 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.

  PMID: 30859382 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Inflammation

Interventions

tocilizumab; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ignatios Ikonomidis, MD

  National and Kapodistrain University of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignatios Ikonomidis, MD

CONTACT

00302105832187; ignoik@otenet.gr

John Lekakis, MD

CONTACT

00302105832187; lekakisster@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology

Study Record Dates

• First Submitted: September 16, 2017
• First Posted: September 20, 2017
• Study Start: October 27, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)