|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03288584 |
|
Date of registration:
|
16/09/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis
|
|
Scientific title:
|
The Effect of Inhibition of Interleukin-6 Activity on Vascular, Endothelial and Left Ventricular Function in Patients With Rheumatoid Arthritis |
|
Date of first enrolment:
|
October 27, 2017 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03288584 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Greece
| | | | | | | |
|
Contacts
|
|
Name:
|
Ignatios Ikonomidis, MD |
|
Address:
|
|
|
Telephone:
|
00302105832187 |
|
Email:
|
ignoik@otenet.gr |
|
Affiliation:
|
|
|
|
Name:
|
Ignatios Ikonomidis, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
National and Kapodistrain University of Athens |
|
|
Name:
|
Ignatios Ikonomidis, MD |
|
Address:
|
|
|
Telephone:
|
00302105832187 |
|
Email:
|
ignoik@otenet.gr |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Familiar hyperlipidemia
- Diabetes mellitus
- Chronic obstructive pulmonary disease or asthma
- Moderate or severe valvular heart disease
- Primary cardiomyopathies
- Malignant tumors
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Rheumatoid Arthritis
|
|
Inflammation
|
|
Intervention(s)
|
|
Drug: Tocilizumab (Actemra®)
|
|
Drug: Other biological agent
|
|
Drug: Corticosteroid and non-biological agents.
|
|
Primary Outcome(s)
|
|
Increase of global longitudinal strain after treatment with tocilizumab
[Time Frame: 3 months after treatment]
|
|
Reduction of pulse wave velocity after treatment with tocilizumab
[Time Frame: 3 months after treatment]
|
|
Secondary Outcome(s)
|
|
Reduction of protein carbonyls after treatment with tocilizumab
[Time Frame: 3 months after treatment]
|
|
Reduction of malondialdehyde after treatment with tocilizumab
[Time Frame: 3 months after treatment]
|
|
Increased of endothelial glycocalyx thickness after treatment with tocilizumab
[Time Frame: 3 months after treatment]
|
|
Secondary ID(s)
|
|
RA-IL6-ATTIKON
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|