No registrations found.
ID
Source
Brief title
Health condition
Rheumatoid arthritis, endothelial activation, endothelial dysfunction, intima media thickness, cardio-vascular disease, everolimus
Sponsors and support
UMC Groningen
Intervention
Outcome measures
Primary outcome
1. Endothelial activation as measured by von Willebrand factor, soluble vascular adhesion molecule, thrombomodulin;
2. Endothelial dysfunction as measured by small artery elasticity;
3. Premature atherosclerosis as measured by intima media thickness.
Secondary outcome
1. Effect of everolimus on RA;
2. Drop-out due to side effects of everolimus.
Background summary
N/A
Study objective
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.
Study design
All parameters are measured at t=0 and t= 6 months.
Intervention
Patients are treated with everolimus for six months, target plasma concentration of everolimus 6-10 ng/ml.
Lodewijk Groot, de
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 36112945
lodewijk.de.groot@reuma.umcg.nl
Lodewijk Groot, de
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 36112945
lodewijk.de.groot@reuma.umcg.nl
Inclusion criteria
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.
Exclusion criteria
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.
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 | NL2249 |
| NTR-old | NTR2376 |
| CCMO | NL27732.042.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |