Effects of Interleukin-1 Inhibition on Vascular and Left Ventricular Function in Rheumatoid Arthritis Patients With Coronary Artery Disease

NCT01566201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-12-03

No results posted yet for this study

Summary

Inhibition of interleukin-1 (IL-1) activity in patients with RA without CAD ameliorates vascular and LV function. Moreover, data from species shows beneficial effect of this treatment on LV function after experimental myocardial infarction. The purpose of this study is to investigate whether anakinra, an IL-1 receptor antagonist, improves vascular and left ventricular (LV) function in patients with coronary artery disease (CAD) and coexistent rheumatoid arthritis (RA).

Conditions

Interventions

DRUG

anakinra

Inhibition of Interleukin-1 activity by anakinra (Kineret®) 100mg od, sc injection

DRUG

placebo

water for injection

Sponsors & Collaborators

  • University of Athens

    lead OTHER

Principal Investigators

  • Ignatios Ikonomidis, MD · 2nd Cardiology Department, University of Athens, Greece

  • Stavros Tzortzis, MD · 2nd Cardiology Department, University of Athens, Greece

  • John P. Lekakis, MD · 2nd Cardiology Department, University of Athens, Greece

  • Ioanna Andreadou, Dr · Department of Pharmaceutical Chemistry, University of Athens Medical School, Greece

  • Ioannis Paraskevaidis, MD · 2nd Cardiology Department, University of Athens, Greece

  • Maria Anastasiou-Nana, MD · 2nd Cardiology Department, University of Athens, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-04-30
Completion
2013-06-30

Countries

  • Greece

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01566201 on ClinicalTrials.gov