NCT01566201

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

March 27, 2012

Last Update Submit

December 1, 2014

Conditions

Rheumatoid ArthritisCoronary Artery DiseaseInflammation

Keywords

Arterial stiffnessEndothelial functionLeft ventricular functionApoptosisNitrooxidative stress

Outcome Measures

Primary Outcomes (1)

  • Improvement in vascular and left ventricular function after anakinra

    Improvement in vascular and left ventricular function after administration of anakinra compared to placebo

    3 hours after treatment

Secondary Outcomes (1)

  • Reduction of nitrooxidative stress and apoptosis after anakinra treatment

    3 hours after treatment

Study Arms (2)

anakinra

ACTIVE COMPARATOR
Drug: anakinra

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

anakinraDRUG

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

Also known as: Kineret® (anakinra)
anakinra
placeboDRUG

water for injection

Also known as: water for injection
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with rheumatoid arthritis and coexistent coronary artery disease or without CAD who had an inadequate response to disease modifying antirheumatic drugs (DMARDs) and corticosteroids and were going to initiate treatment with interleukin-1 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Attikon" University General Hospital

Haidari, Athens, Attica, 12462, Greece

Location

Related Publications (1)

  • Ikonomidis I, Tzortzis S, Andreadou I, Paraskevaidis I, Katseli C, Katsimbri P, Pavlidis G, Parissis J, Kremastinos D, Anastasiou-Nana M, Lekakis J. Increased benefit of interleukin-1 inhibition on vascular function, myocardial deformation, and twisting in patients with coronary artery disease and coexisting rheumatoid arthritis. Circ Cardiovasc Imaging. 2014 Jul;7(4):619-28. doi: 10.1161/CIRCIMAGING.113.001193. Epub 2014 Apr 29.

    PMID: 24782115DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidCoronary Artery DiseaseInflammation

Interventions

Interleukin 1 Receptor Antagonist ProteinWaterInjections

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Ignatios Ikonomidis, MD

    2nd Cardiology Department, University of Athens, Greece

    PRINCIPAL INVESTIGATOR

  • Stavros Tzortzis, MD

    2nd Cardiology Department, University of Athens, Greece

    PRINCIPAL INVESTIGATOR

  • John P. Lekakis, MD

    2nd Cardiology Department, University of Athens, Greece

    PRINCIPAL INVESTIGATOR

  • Ioanna Andreadou, Dr

    Department of Pharmaceutical Chemistry, University of Athens Medical School, Greece

    PRINCIPAL INVESTIGATOR

  • Ioannis Paraskevaidis, MD

    2nd Cardiology Department, University of Athens, Greece

    PRINCIPAL INVESTIGATOR

  • Maria Anastasiou-Nana, MD

    2nd Cardiology Department, University of Athens, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Cardiology

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 29, 2012

Study Start

March 1, 2011

Primary Completion

April 1, 2012

Study Completion

June 1, 2013

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

GR(1)