Cardio-vascular disease is increased in RA. Everolimus has shown to have beneficial effects on endothelial function in cardiac tranplant patients and renal transplant patients. We want to study the effect of everolimus in patients with active RA.
ID
Bron
Verkorte titel
Aandoening
Rheumatoid arthritis, endothelial activation, endothelial dysfunction, intima media thickness, cardio-vascular disease, everolimus
Ondersteuning
UMC Groningen
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Endothelial activation as measured by von Willebrand factor, soluble vascular adhesion molecule, thrombomodulin;<br>
2. Endothelial dysfunction as measured by small artery elasticity;<br>
3. Premature atherosclerosis as measured by intima media thickness.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Cardio-vascular disease is increased in RA. Everolimus has shown to have beneficial effects on endothelial function in cardiac tranplant patients and renal transplant patients. We want to study the effect of everolimus in patients with active RA.
Onderzoeksopzet
All parameters are measured at t=0 and t= 6 months.
Onderzoeksproduct en/of interventie
Patients are treated with everolimus for six months, target plasma concentration of everolimus 6-10 ng/ml.
Publiek
Lodewijk Groot, de
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 36112945
lodewijk.de.groot@reuma.umcg.nl
Wetenschappelijk
Lodewijk Groot, de
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 36112945
lodewijk.de.groot@reuma.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Fulfill the American College of Rheumatology criteria for RA;
2. DAS-28 score>3,2;
3. Female/male patients 18-80 years of age;
4. Mentally able to understand the written information and to make the decision to participate;
5. Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregnancy or breastfeeding status;
2. Diabetes mellitus (fasting blood glucose =/> 7.0 mmol/L);
3. Renal impairment (eGFR <60ml/min);
4. Recent Surgery;
5. MI or sepsis in the past three months.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2249 |
| NTR-old | NTR2376 |
| CCMO | NL27732.042.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |