To investigate the effect of anti-IL6 therapy with tocilizumab on subclinical arterial inflammation (endothelial dysfunction) and stiffness in patients with treatment resistant rheumatoid arthritis at baseline and after 6 months treatment
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Influence of disease activity on arterial stiffness as measured by pulse wave
velocity in RA patients receiving tocilizumab
Secondary outcome
Pulse Wave Analysis (PWA) measuring central blood pressure (CBP) and
augmentation index (AIx) , using Sphygmocor apparatus, effect on skin
autofluorescence as a marker for tissue AGE accumulation and measuring
endothelial progenitor cells (EPC's) and serum endothelial activation markers
such as thrombomodulin (TM), soluble vascular cell adhesion molecule-1
(sVCAM-1), and von Willebrand factor (vWF) , and Lipopolysaccharide (LPS)
stimulated cytokine (IL-1β, IL-6, IL-8, IL-10 and TNF-α) production in
peripheral blood mononuclear cells. Throughout the study, medication and other
influencing factors of endothelial dysfunction will be kept as steady as
possible. Changes in traditional risk factors as smoking, hypertension, use of
antihypertensive drugs or dyslipidemia and BMI will be recorded.
Background summary
RA is an independent risk factor for the development of cardiovascular disease
(CVD). Biological and non-biological DMARDS that suppress systemic inflammation
have also been shown to decrease cardiovascular disease risk. It is however
unclear which inflammatory mechanisms contribute to the specific
atherosclerotic complication of RA. We therefore want to investigate the
effect of anti-IL6 therapy with tocilizumab (TCZ) on subclinical arterial
inflammation and stiffness in patients with active rheumatoid arthritis with an
indication for TCZ treatment.
Study objective
To investigate the effect of anti-IL6 therapy with tocilizumab on subclinical
arterial inflammation (endothelial dysfunction) and stiffness in patients with
treatment resistant rheumatoid arthritis at baseline and after 6 months
treatment
Study design
observational study
Study burden and risks
Before start of the study and at 6 months 50ml of blood extra will be drawn
beside the routine blood samples for RA.
Secondly, patients will have measurements of arterial stiffness, AGE
accumulation at the vascular department. Measurements of arterial stiffness and
AGE accumulation are usually well tolerated and non-invasive, but do take time
from the patient and patients have to be fasting in the morning of the
measurements.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
• Patients fulfilling the American College of Rheumatology criteria for RA at diagnosis
• Active RA; DAS-28 score > 3.2
• Indication for treatment with tocilizumab.
• Female/male patients 18-80 years of age.
• Mentally able to understand the written information and to make the decision to
participate.
• Written Informed consent
Exclusion criteria
• Pregnancy
• Insulin dependent Diabetes Mellitus
• Renal impairment (eGFR <30ml/min)
• MI or sepsis in the past three months
• Unable to lay flat for 30-45 minutes for the PWV measurement
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46764.042.14 |
| Other | volgt |