Effect of interruption of TNFi on endothelial function in patients with rheumatoid arthritis
Recruiting
- Conditions
- reumatoide artritis1002321310003216
- Registration Number
- NL-OMON37380
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
a. Informed consent for POEET trial and this additional study;b. On stable medication (except for TNFi-therapy)
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)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the interaction between TNFi-withdrawal and the<br /><br>vasodilator response to acetylcholine expressed as difference in FBF between<br /><br>the withdrawal group and the continuing group.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are the effect of TNFi-withdrawal on circulating VCAM and<br /><br>ICAM<br /><br>Secondary endpoints are The the interaction between TNFi-withdrawal and the<br /><br>vasodilator response to nitroprusside (expressed as difference in FBF between<br /><br>the withdrawal group and the continuing group). The response to SNP serves as<br /><br>an internal vasodilator control to assess potential endothelium-independent<br /><br>effects of TNFi-withdrawal on the response to acetylcholin.</p><br>