reumatoide artritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a. Informed consent for POEET trial and this additional study;b. On stable medication (except for TNFi-therapy)
Exclusion criteria
Exclusion criteria: a. Uncontrolled hypertension (RR > 140/90 mmHg average of three measurements at screening after 5 minutes of supine rest);b. Diabetes mellitus;c. Heart failure or any other cardiovascular disease that is expected to induce changes in cardiovascular medication during the study period.;d. Expected to start or change medication that can alter endothelial function (lipid lowering drugs, blood pressure lowering drugs, NSAIDs, immunosuppressive therapy other than TNFi drugs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the interaction between TNFi-withdrawal and the vasodilator response to acetylcholine expressed as difference in FBF between the withdrawal group and the continuing group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the effect of TNFi-withdrawal on circulating VCAM and ICAM Secondary endpoints are The the interaction between TNFi-withdrawal and the vasodilator response to nitroprusside (expressed as difference in FBF between the withdrawal group and the continuing group). The response to SNP serves as an internal vasodilator control to assess potential endothelium-independent effects of TNFi-withdrawal on the response to acetylcholin. | — |
Countries
Netherlands