No registrations found.
ID
Source
Brief title
Health condition
Rheumatoid Arthritis
Sponsors and support
Amsterdam, the Netherlands
Intervention
Outcome measures
Primary outcome
1. Endothelial Function (FMD);
2. Glycocalyx;
Before treatment, 0-4 weeks after treatment, 9-12 weeks after treatment.
Secondary outcome
1. Atherosclerosis:
Plasma: Total cholesterol, LDL, HDL, Triglycerides, Lp(a), ox-LDL;
2. Thrombosis:
D-dimer, F1+2, sTF, PAI-I;
3. Inflammation:
IL-1beta, TNF-alpha, IL-6, IL-8, IL-10, hsCRP.
Before treatment, 0-4 weeks after treatment, 9-12 weeks after treatment.
Background summary
Rationale:
Rheumatoid arthritis is associated with an increased incidence of atherosclerotic vascular disease. It is suggested that systemic inflammation is a risk factor for enhanced atherogenesis which is for instance also observed in SLE. In line with this, TNF-alpha is a central mediator of inflammation in RA and inhibition thereof may exert anti-atherothrombotic effects.
Objective:
In the current study we aim to establish whether TNF-alpha plays a central role in inflammation-mediated acceleration of atherogenesis and the propencity towards development of atherothrombotic disease in RA.
Study design:
This is an observational study in RA patients undergoing therapy with TNF-alpha blockade. Prior to receiving treatment surrogate markers for atherosclerosis, thrombosis, inflammation and angiogenesis will be assessed. These measurements will be repeated to evaluate short-term and long-term effects.
Study population:
We will include RA patients who are experiencing an inflammatory exacerbation of RA and who will be treated with TNF-alpha blockade.
Main study parameters:
Surrogate markers for atherosclerosis (endothelial function, glycocalyx), thrombosis (PMC, plasma markers), inflammation and angiogenesis (plasma markers).
Nature and extent of the burden and risks associated with participation, benefit and group telatedness: This is an observational study evaluating additional benefits (anti-atherothrombotic effects) of standard clinical practice (TNF-alpha blockade). Measurement of endothelial function and glycocalyx volume are routinely performed at the department of vascular medicine.
Study objective
In the current study we aim to establish whether TNF-alpha plays a central role in inflammation-mediated acceleration of atherogenesis and the propencity towards development of atherothrombotic disease in RA.
Study design
N/A
Intervention
TNF-alpha blockade.
(patients are their own control)
P.O. Box 22660
Sander Leuven, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5668675
s.i.vanleuven@amc.uva.nl
P.O. Box 22660
Sander Leuven, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5668675
s.i.vanleuven@amc.uva.nl
Inclusion criteria
1. Male or female patients who were priorly diagnosed with RA, who are currently experiencing an inflammatory episode and who will be treated with TNF-alpha blockade;
2. Age 18-80 years.
Exclusion criteria
1. Patients who were priorly diagnosed with diabetes, hypertension or cardiovascular disease;
2. Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease.
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 |
|---|---|
| NTR-new | NL824 |
| NTR-old | NTR837 |
| Other | : N/A |
| ISRCTN | ISRCTN26286159 |