search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Tumor Necrosis Factor blockade in patients with Rheumatoid Arthritis inhibits Atherothrombosis.


- candidate number2365
- NTR NumberNTR837
- ISRCTNISRCTN26286159
- Date ISRCTN created16-jan-2007
- date ISRCTN requested29-dec-2006
- Date Registered NTR12-dec-2006
- Secondary IDsN/A 
- Public TitleTumor Necrosis Factor blockade in patients with Rheumatoid Arthritis inhibits Atherothrombosis.
- Scientific TitleTumor Necrosis Factor blockade in patients with Rheumatoid Arthritis inhibits Atherothrombosis.
- ACRONYMTUNDRA
- hypothesisIn 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.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate31-dec-2007
- Target number of participants15
- InterventionsTNF-alpha blockade. (patients are their own control)
- Primary outcome1. Endothelial Function (FMD);
2. Glycocalyx;
Before treatment, 0-4 weeks after treatment, 9-12 weeks after treatment.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. Sander Leuven, van
- CONTACT for SCIENTIFIC QUERIESMD. Sander Leuven, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Vascular Medicine
- PublicationsN/A
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD12-dec-2006 - 18-jan-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl