| - candidate number | 2365 |
| - NTR Number | NTR837 |
| - ISRCTN | ISRCTN26286159 |
| - Date ISRCTN created | 16-jan-2007 |
| - date ISRCTN requested | 29-dec-2006 |
| - Date Registered NTR | 12-dec-2006 |
| - Secondary IDs | N/A |
| - Public Title | Tumor Necrosis Factor blockade in patients with Rheumatoid Arthritis inhibits Atherothrombosis. |
| - Scientific Title | Tumor Necrosis Factor blockade in patients with Rheumatoid Arthritis inhibits Atherothrombosis. |
| - ACRONYM | TUNDRA |
| - hypothesis | 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. |
| - Healt Condition(s) or Problem(s) studied | Rheumatoid arthritis |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | Factorial |
| - Type | Single arm |
| - Studytype | intervention |
| - planned startdate | 1-jan-2006 |
| - planned closingdate | 31-dec-2007 |
| - Target number of participants | 15 |
| - Interventions | TNF-alpha blockade. (patients are their own control) |
| - 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. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | MD. Sander Leuven, van |
| - CONTACT for SCIENTIFIC QUERIES | MD. Sander Leuven, van |
| - Sponsor/Initiator | Academic Medical Center (AMC) |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Department of Vascular Medicine |
| - Publications | N/A |
| - Brief 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. |
| - Main changes (audit trail) | |
| - RECORD | 12-dec-2006 - 18-jan-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl